[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Eisai Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":197},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,40,64,89,113,148,174],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100651996","phase-1-a-study-to-evaluate-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-e2511-in-participants-with-early-alzheimers-disease-ad-100651996",false,"NCT07768592","A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2511 in Participants With Early Alzheimer's Disease (AD)","A Proof-of-Mechanism, Open-Label, Parallel Group Study With an Open-Label Extension Phase to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2511 in Participants With Early Alzheimer's Disease","Inclusion Criteria:\n\n1. For participants diagnosed with mild cognitive impairment (MCI) due to AD-intermediate likelihood:\n\n   1. Meet the National Institute on Aging and the Alzheimer's Association (NIA-AA) core clinical criteria for MCI due to AD-intermediate likelihood.\n   2. Have a global Clinical Dementia Rating Scale (CDR) score of 0.5 and a CDR Memory Box score of greater than or equal to (\\>=) 0.5 at Screening and Baseline.\n2. For participants diagnosed with mild AD dementia:\n\n   1. Meet the NIA-AA core clinical criteria for probable AD dementia.\n   2. Have a global CDR score of 0.5 to 1.0 and a CDR Memory Box score of \\>=0.5 at Screening and Baseline.\n3. Mini Mental State Examination (MMSE) score \\>=22 and less than or equal to (\\\u003C=) 30 at Screening.\n4. Evidence of brain amyloid pathology as indicated by one of the following:\n\n   1. Plasma phosphorylated tau217 (p-tau217) assay performed at Screening.\n   2. Historical plasma p-tau217 assay performed before screening.\n   3. Historical cerebrospinal fluid (CSF) or amyloid PET assessment performed before Screening.\n5. Nonsmoking and nonvaping, male or female, aged \\>=50 years and \\\u003C=85 years old, at the time of informed consent.\n6. Body Mass Index (BMI) greater than 17 and less than 35 at Screening.\n7. Have an identified trial partner (defined as a person able to support the participant for the duration of the trial and who spends at least 8 hours per week with the participant). The trial partner must provide separate written informed consent. In addition, this person must be willing and able to provide follow-up information on the participant throughout the course of the trial. This person must, in the opinion of the investigator, spend sufficient time with the participant on a regular basis such that the trial partner can reliably fulfill the trial requirements. A permanent trial partner need not be living in the same residence with the participant. For such a trial partner not residing with the participant, the investigator has to be satisfied that the participant can contact the trial partner readily during the times when the trial partner is not with the participant. If in doubt about whether a participant's care arrangements are suitable for inclusion, the investigator should discuss this with the medical monitor. Trial partners need to participate in person for visits where clinical assessments, such as CDR (global and CDR-SB), take place.\n8. Able to undergo CSF lumbar puncture and not receiving any anticoagulant therapy or currently suffering from a medical condition that may require initiation of any anticoagulant therapy at Screening.\n9. Provide written informed consent. If a participant lacks the capacity to consent in the investigator's opinion, the participant's assent should be obtained, if required in accordance with local laws, regulations, and customs, plus the written informed consent of a legal representative should be obtained (capacity to consent and definition of legal representative should be determined in accordance with applicable local laws and regulations).\n10. Willing and able to comply with all aspects of the protocol including multiple CSF collections.\n\nExclusion Criteria:\n\n1. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin \\[β-hCG\\] or human chorionic gonadotropin \\[hCG\\] test with a minimum sensitivity of 25 International Units per Liter \\[IU\u002FL\\] or equivalent units of β-hCG \\[or hCG\\]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of trial drug.\n2. Females of childbearing potential who:\n\n   * Within 28 days before trial entry, did not use a highly effective method of contraception, which includes any of the following:\n\n     * total abstinence (if it is their preferred and usual lifestyle)\n     * an intrauterine device or intrauterine hormone-releasing system (IUS)\n     * a contraceptive implant\n     * an oral contraceptive (participant must have been on a stable dose of the same oral contraceptive product for at least 28 days before dosing and must agree to stay on the same dose of the oral contraceptive throughout the trial and for 28 days after trial drug discontinuation)\n     * have a vasectomized partner with confirmed azoospermia.\n   * Do not agree to use a highly effective method of contraception (as described above) throughout the entire trial period and for 28 days after trial drug discontinuation.\n\n   NOTE: It is permissible that if a highly effective method of contraception is not appropriate or acceptable to the participant, then the participant must agree to use a medically acceptable method of contraception, i.e., double-barrier methods of contraception such as latex or synthetic condom plus diaphragm or cervical\u002Fvault cap with spermicide. All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).\n3. Males who have not had a successful vasectomy (confirmed azoospermia) if their female partners meet the exclusion criteria above (i.e., the female partners are of childbearing potential and are not willing to use a highly effective contraceptive method throughout the trial period and for 5 times the half-life of the trial drug plus 90 days after trial drug discontinuation). No sperm donation is allowed during the trial period and for 5 times the half-life of the trial drug plus 90 days after trial drug discontinuation.\n4. Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the participant's MCI or AD.\n5. History of transient ischemic attacks, stroke, or seizures within 12 months of Screening.\n6. Any lifetime history of psychiatric disease (including but not limited to depression or other mood disorders, bipolar disorder, psychotic disorders, including schizophrenia, panic attacks, anxiety disorders).\n7. Any suicidal ideation with intent with or without a plan at Screening or within 6 months of Screening (i.e., answering \"Yes\" to questions 4 or 5 on the Suicidal Ideation section of the C-SSRS).\n8. Any lifetime suicidal behavior (per the Suicidal Behavior Section of the C-SSRS).\n9. Contraindications to magnetic resonance imaging (MRI) scanning, including cardiac pacemaker\u002Fdefibrillator, and ferromagnetic metal implants (eg, in skull and cardiac devices other than those approved as safe for use in MRI scanners).\n10. Evidence of other clinically significant lesions on brain MRI at Screening that could indicate a dementia diagnosis other than AD.\n11. Other significant pathological findings on brain MRI at Screening, including but not limited to: evidence of cerebral contusion, encephalomalacia, aneurysms, vascular malformations, or infective lesions; evidence of multiple lacunar infarcts or stroke involving a major vascular territory, severe small vessel, or white matter disease; space occupying lesions; or brain tumors (however, lesions diagnosed as meningiomas or arachnoid cysts and less than 1 centimeter \\[cm\\] at their greatest diameter need not be exclusionary). Other minor or clinically insignificant MRI abnormalities, as agreed by the medical monitor and after discussion with the investigator, may not be exclusionary.\n12. Malignant neoplasms within 3 years of Screening (except for basal or squamous cell carcinoma in situ of the skin, localized prostate cancer in male participants, or localized breast cancer in female participants). Participants who had malignant neoplasms but who have had at least 3 years of documented uninterrupted remission before Screening need not be excluded.\n13. A clinically significant ECG abnormality, including a marked prolonged corrected QT interval (Fridericia's Correction Formula) (eg, a repeated demonstration of a QTcF interval greater than \\[\\>\\] 450 milliseconds \\[ms\\]).\n14. Participants with a bleeding disorder that is not under adequate control (including a platelet count \\\u003C50,000 or international normalized ratio \\[INR\\] \\>1.5). Participants who are on anticoagulant therapy are not permitted to be enrolled.\n15. Have thyroid-stimulating hormone above the normal range. Other tests of thyroid function with results outside the normal range should only be exclusionary if they are considered clinically significant by the investigator. This applies to all participants whether or not they are taking thyroid supplements. If the thyroid-stimulating hormone returns to normal range with thyroid replacement therapy, then participants may be allowed to enroll without rescreening if they meet all other inclusion criteria and did not meet any exclusion criteria.\n16. Abnormally low serum vitamin B12 levels for the testing laboratory (if a participant is taking vitamin B12 injections, level should be at or above the lower limit of normal for the testing laboratory). Levels of vitamin B12 may be confirmed with reflex testing to include methylmalonic acid analysis, if available in the region. If vitamin B12 levels return to normal range with supplement treatment, then participants may be allowed to enroll without rescreening if they meet all other inclusion criteria and did not meet any exclusion criteria.\n17. Evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, and renal disease) that in the opinion of the investigator(s) could affect the participant's safety or interfere with the trial assessments. Any other medical conditions (eg, cardiac, respiratory, gastrointestinal, and renal disease) that are not stably and adequately controlled or that in the opinion of the investigator(s) could affect the participant's safety or interfere with the trial assessments.\n18. Any history of or concomitant medical condition that in the opinion of the investigator(s) would compromise the participant's ability to safely complete the trial.\n19. Planned surgery that requires general, spinal, or epidural anesthesia that would take place during the trial. Planned surgery that requires only local anesthesia and that can be undertaken as a day case without inpatient stay postoperatively need not result in exclusion if in the opinion of the investigator this operation does not interfere with trial procedures and participant's safety.\n20. Known to be human immunodeficiency virus positive.\n21. Known or suspected history of drug or alcohol abuse or dependence within 2 years before Screening or a positive urine drug test at Screening. Participants who test positive for benzodiazepines or opioids in urine drug testing need not be excluded if, in the clinical opinion of the investigator, this is due to the participant taking prior\u002Fconcomitant medications containing benzodiazepines or opioids for a medical condition and not due to drug abuse.\n22. Severe visual or hearing impairment that would prevent the participant from performing psychometric tests accurately.\n23. Active viral hepatitis (A, B, or C) as demonstrated by positive serology at Screening.\n24. Currently enrolled in another clinical trial or used any investigational drug or device within 28 days or 5 half-lives of the other investigational drug, whichever is longer, preceding informed consent.\n25. Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week of dosing.\n26. Participants who contravene the restrictions on medications, food, beverages, physical activities, and others as defined in the protocol at Screening or Baseline.\n27. Participants with contraindications to lumbar puncture.\n28. Known hypersensitivity to donepezil hydrochloride or to piperidine derivatives.\n29. Taking a cholinesterase inhibitor unless willing to discontinue cholinesterase inhibitor treatment for 21 days before Screening and until the last visit during the Core Trial.\n30. Participation in a clinical trial for AD involving any antisense oligonucleotide or silencing ribonucleic acid (RNA) therapies targeting amyloid or tau unless it can be documented that the participant only received placebo.\n31. Participation in a clinical trial for AD involving pharmaceutical intervention other than antisense oligonucleotide or silencing RNA therapies (eg, small molecules, monoclonal antibodies) within 6 months of Screening unless it can be documented that the participant only received placebo.\n32. Participants who have taken approved anti-amyloid monoclonal antibodies (eg, LEQEMBI, KISUNLA) within 6 months of Screening.\n33. Any history of surgery that may affect pharmacokinetic (PK) profiles of trial drug (eg, hepatectomy, nephrectomy, digestive organ resection) or participants who have a congenital abnormality in metabolism at Screening.\n34. Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.","ALL","50 Years","85 Years",{"count":20,"type":21},32,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The primary purpose of this study is to evaluate proof of mechanism (POM) and long-term safety and tolerability of E2511 in participants with Early AD. The study consists of 2 parts. In Part A, participants will be randomly assigned to receive either E2511 or donepezil. In Part B, participants will receive E2511 only. Once Part A and Part B participants complete the Core Trial (which includes Pretreatment and Treatment phases) they will have the option to enter the Extension Phase where they will receive E2511 for 18 months.",[27],"Alzheimers Disease","NOT_YET_RECRUITING","2026-08-12",{"date":31,"type":32},"2026-08-17","ACTUAL",{"date":34,"type":21},"2026-10-15",{"date":36,"type":21},"2030-05-06",{"name":38,"class":39},"Eisai Inc.","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100651743","phase-1-a-study-to-assess-potential-drug-drug-interactions-of-e2086-in-healthy-participants-100651743","NCT07766369","A Study to Assess Potential Drug-Drug Interactions of E2086 in Healthy Participants","A Phase 1, Open-label, 3-Part Study to Assess Potential Drug-Drug Interactions of E2086 When Coadministered Orally With Itraconazole, Carbamazepine, Midazolam, Dextromethorphan, Bupropion, or Combined Oral Contraceptives in Healthy Subjects","Inclusion Criteria:\n\n1. Body Mass Index (BMI) greater than or equal to (≥) 18 and less than (\\\u003C) 30 kilograms per square meter (kg\u002Fm2) at Screening\n2. Non-smoking and non-vaping, healthy male or female, age ≥18 years and ≤55 years old at the time of informed consent (only Parts A and B).\n3. Non-smoking and non-vaping, healthy female, age ≥18 years and ≤55 years old at the time of informed consent (only Part C).\n\nExclusion Criteria:\n\n1. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin \\[ß-hCG\\] or human chorionic gonadotropin \\[hCG\\] test with a minimum sensitivity of 25 international units per liter (IU\u002FL) or equivalent units of ß-hCG or hCG). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug\n2. Females of childbearing potential who did not use a highly effective method of contraception (as described below) within 28 days before study entry, or who do not agree to use an approved method of contraception from 28 days before study entry throughout the entire study period, and for 28 days after study drug discontinuation.\n\n   Approved (highly effective) methods of contraception for this study include at least 1 of the following:\n   * Total abstinence (if it is her preferred and usual lifestyle)\n   * Have a vasectomized partner with confirmed azoospermia\n   * Double-barrier method (such as condom plus diaphragm with spermicide) NOTE: All females will be considered of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).\n3. Subjects who are using steroidal hormones including for contraceptives, implants and intrauterine system, or for any other indications from 4 weeks before informed consent until study discharge from the final period\n4. Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing\n5. Evidence of disease that may influence the outcome of the study within 4 weeks before dosing; eg, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system\n6. Any history of surgery that may affect pharmacokinetics (PK) profiles of E2086 (eg, hepatectomy, nephrectomy, digestive organ resection) or subjects who have a congenital abnormality in metabolism at Screening\n7. Any clinically abnormal symptom or organ impairment found by medical history at Screening, including estimated glomerular filtration rate (eGFR) \\\u003C90 milliliters per minute (ml\u002Fmin), and physical examinations, vital signs, ECG findings, or laboratory test results that require medical treatment at Screening or Baseline\n8. A prolonged QT\u002Fcorrected (QTc) interval (QT interval corrected for heart rate using Fridericia's formula \\[QTcF\\] \\>450 millisecond \\[ms\\]) as demonstrated by the mean of triplicate ECGs (recorded at least 1 minute \\[min\\] apart) at Screening or Baseline\n9. Systolic blood pressure \\>140 millimeters of mercury (mmHg) or diastolic blood pressure \\>90 mmHg at Screening or Baseline\n10. Heart rate \\\u003C50 beats per (\u002F) min or \\>100 beats\u002Fmin at Screening or Baseline\n11. Any lifetime history of suicidal ideation or any lifetime history of suicidal behavior as indicated by the Columbia-Suicide Severity Rating Scale (C-SSRS).\n12. Any lifetime history of psychiatric disease (including, but not limited to, depression or other mood disorders, bipolar disorder, psychotic disorders, including schizophrenia, panic attacks, and anxiety disorders \\[if ever treated with medication\\]).\n13. Known history of clinically significant drug allergy at Screening\n14. Known history of food allergies or presently experiencing significant seasonal or perennial allergy at Screening\n15. Known to be human immunodeficiency virus (HIV) positive at Screening\n16. History of drug or alcohol dependency or abuse within the 2 years before Screening, or those who have a positive urine drug test or breath alcohol test at Screening or Baseline.\n17. Currently enrolled in another clinical study or used any investigational drug or device within 28 days (or 5 half-lives, whichever is longer) preceding informed consent\n18. Use of illegal recreational drugs and marijuana\n19. Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week before dosing.\n20. A history of noncompliance in any previous study or inability to comply with study conduct, as assessed by the investigator\n21. Any other findings that the investigator feels would increase the risk of having an adverse outcome from participating in the study\n22. Subjects carrying human leukocyte antigen (HLA)-B\\*1502 or HLA-A\\*3101 (only Part A -CBZ treatment group)\n23. Genetically determined poor metabolizers of CYP2D6 substrates (only Part B - MDZ, DEX, and BUP)",true,"18 Years","55 Years",{"count":51,"type":21},93,[24],"The primary purpose of this study is to assess potential drug-drug interactions of E2086 when coadministered orally with Itraconazole, Carbamazepine, Midazolam, Dextromethorphan, Bupropion, or Combined Oral Contraceptives in Healthy Participants",[55],"Healthy Volunteers","2026-08-11",{"date":58,"type":32},"2026-08-14",{"date":29,"type":21},{"date":61,"type":21},"2026-11-12",{"name":38,"class":39},1,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":73,"phases":4,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":4},"100648414","a-retrospective-database-study-for-the-development-and-validation-of-algorithms-for-intracerebral-hemorrhage-and-seizures-in-alzheimers-disease-100648414","NCT07723950","A Retrospective Database Study for the Development and Validation of Algorithms for Intracerebral Hemorrhage and Seizures in Alzheimer's Disease","Development and Validation of Algorithms for Identifying Intracerebral Hemorrhage and Seizures in Patients With Alzheimer's Disease: A Retrospective Database Study Using United States Healthcare Administrative Claims Data","Inclusion Criteria:\n\n* Before or on the outcome event date, have at least 1 ICD-10-CM diagnosis code for AD in medical claims in an inpatient setting; or have at least 2 ICD-10-CM diagnosis codes in medical claims in an outpatient setting, at least 7 days and less than 365 days apart\n* Have at least 365 days of continuous coverage with medical and pharmacy benefits before the outcome event date\n* Have EHR data available for (1) the outcome event date or (2) during the period of up to 30 days before and up to 90 days after the outcome event date\n* Have unstructured EHR information (ie, clinical notes) available for any encounter (1) on the outcome event date or (2) during the period of 30 days before to up to 45 days after the outcome event date\n\nExclusion Criteria:\n\n* New-onset seizure outcome only: Have any ICD-10-CM diagnosis code for seizure or epilepsy before the outcome event date",{"count":72,"type":21},600,"OBSERVATIONAL","The primary objective of this study is to develop and validate claims-based algorithms to identify intracerebral hemorrhage \\>1 cm in diameter, ensuring differentiation from amyloid-related imaging abnormality-microhemorrhage and hemosiderin deposit (ARIA-H; microhemorrhage, superficial siderosis) in participants with Alzheimer's disease (AD) using claims data in the United States (US) with linkage to electronic health records (EHRs), and to estimate the positive predictive values (PPVs) of the algorithms. The secondary objective of the study is to validate claims-based algorithms to identify new-onset seizures in participants with AD using US claims data with linkage to EHRs and to estimate the PPVs of the algorithms.",[76],"Alzheimer's Disease",[76,78,79,80],"Intracerebral Hemorrhage","Seizures","US Healthcare Claims Data","2026-07-20",{"date":83,"type":32},"2026-07-23",{"date":85,"type":21},"2026-07-30",{"date":87,"type":21},"2026-12-31",{"name":38,"class":39},{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":96,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":97,"phases":4,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":111,"locationsCount":112},"100345493","an-extended-access-program-eap-for-participants-who-have-completed-rufinamide-study-e2080-g000-303-100345493","NCT03778424","An Extended Access Program (EAP) for Participants Who Have Completed Rufinamide Study E2080-G000-303","An Extended Access Program (EAP) for Rufinamide in Pediatric Participants With Inadequately Controlled Lennox-Gastaut Syndrome","Inclusion Criteria:\n\n* Participants who were on rufinamide treatment and have completed Study E2080-G000-303 in Poland.\n\nExclusion Criteria:\n\n* Participants were randomized to the other antiepileptic drug (AED) treatment group in study E2080-G000-303.","4 Years","EXPANDED_ACCESS","This is an extended access study for participants who have completed Rufinamide Study E2080-G000-303 to continue to have access to rufinamide until it becomes commercially available in Poland or until no participants remain in the EAP.",[100],"Lennox Gastaut Syndrome",[102,103,104,105,79,106],"Central Nervous System","E2080","Rufinamide","Epilepsy","Brain Diseases","AVAILABLE","2026-07-07",{"date":110,"type":32},"2026-07-08",{"name":38,"class":39},2,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":22,"phases":122,"briefSummary":124,"conditions":125,"keywords":127,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},"100385580","phase-1-a-study-to-evaluate-the-safety-tolerability-and-efficacy-of-morab-202-herein-referred-to-as-farletuzumab-ecteribulin-a-folate-receptor-alpha-fr-targeting-antibody-drug-conjugate-adc-in-participants-with-selected-tumor-types-100385580","NCT04300556","A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types","A Multicenter, Open-Label Phase 1\u002F2 Trial Evaluating the Safety, Tolerability, and Efficacy of MORAb-202, a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Subjects With Selected Tumor Types","Inclusion Criteria:\n\n1. Aged \\>=18 years\n2. For Dose-Escalation: Females (TNBC, EC and OC) or males\u002Ffemales (NSCLC, adenocarcinoma). Participants with the following disease characteristics:\n\n   Participants with the following tumor types, each as a separate arm:\n   1. TNBC: Histologically confirmed diagnosis of metastatic TNBC (that is, estrogen receptor (ER) negative\u002Fprogesterone receptor negative\u002F human epidermal growth factor receptor 2 (HER2) negative (defined as immunohistochemistry (IHC) less than (\\\u003C) 2 plus (+) or fluorescence in situ hybridization (FISH) negative) breast cancer). Previously treated with at least one line of systemic anticancer therapy (cytotoxic or targeted anticancer agents) in the metastatic setting.\n   2. NSCLC adenocarcinoma: Histologically or cytologically confirmed metastatic NSCLC adenocarcinoma: participants who have failed previous treatment for metastatic disease, are not indicated or failed epidermal growth factor receptor (EGFR)-, Anaplastic lymphoma kinase (ALK) -, B-Raf proto-oncogene (BRAF) - or c-ros oncogene 1 (ROS1) - targeted therapy, and for whom no alternative standard therapy exists.\n   3. EC: Histologically confirmed diagnosis of advanced, recurrent or metastatic EC. Relapsed or failure of at least one platinum-based regimen or one immunotherapy-based regimen.\n   4. OC or primary peritoneal cancer or fallopian tube cancer: Histologically confirmed diagnosis of high grade serous epithelial ovarian cancer or primary peritoneal cancer or fallopian tube cancer.\n\n   Participants must have:\n   * platinum-resistant disease (defined as progression within 6 months after the last dose of at least 4 cycles of the last platinum containing chemotherapy regimen)\n   * received up to 4 lines of systemic therapy post development of platinum resistance.\n\n   For Dose-Confirmation and Dose Optimization:\n\n   Note: Only participants with histologically confirmed diagnosis of advanced, recurrent, or metastatic EC will be enrolled at sites in France.\n\n   High-grade serous ovarian cancer or primary peritoneal cancer or fallopian tube cancer:\n   * Platinum-resistant disease:\n\n     * For participant with 1 line of platinum-containing therapy: progression greater than (\\>) 1 month and less than or equal to (\\\u003C=) 6 months after the last dose of the first platinum-containing chemotherapy regimen (of at least 4 cycles)\n     * For participant with 2-3 lines of platinum-containing therapy: progression during or within 6 months after the last dose of the 2nd or 3rd platinum-containing chemotherapy regimen.\n   * Have received up to 3 prior lines of systemic therapy and for whom single-agent therapy is appropriate as the next line of therapy. Participants may have been treated with up to one line of therapy subsequent to determination of platinum-resistance. In Dose Optimization Part B participants may have received up to 3 prior lines of systemic therapy, up to 4 prior lines is permitted for participants who have received prior mirvetuximab soravtansine\n\n     * Neoadjuvant plus\u002Fminus (±) adjuvant will be considered 1 line of therapy.\n     * Maintenance therapy (example, bevacizumab, PARP inhibitors) will be considered part of the preceding line of therapy (will not be counted as an independent line of therapy).\n     * Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance.\n     * Therapy changed due to toxicity in the absence of progression will be considered part of the same line.\n\n   Endometrial cancer (not enrolled in Dose Optimization Part B):\n   * Participants must have histologically confirmed diagnosis of advanced, recurrent, or metastatic EC. All histologic (including carcinosarcoma \\[no more than one participant at any dose level\\]) and molecular subtypes will be included. Participants may have been treated with an Immune Checkpoint Inhibitor (ICI) containing regimen (or be ineligible for ICI treatment) and must have had no more than 2 prior regimens (not including adjuvant therapy if progression or recurrent\u002Fmetastatic disease occurred more than 6 months after the completion of the last cycle of adjuvant therapy).\n   * Note: There is no restriction regarding prior hormonal therapy.\n3. Available tumor tissue for FRA expression percent (%) by IHC analysis as assessed at a central laboratory. There is no minimum requirement for FRA expression (%). However, the tumor sample must be evaluable for IHC analysis (that is, of sufficient quality with adequate tumor content). Sample resubmission will be permitted for participants with tissue result of \"non-evaluable\" who are otherwise eligible. Tumor sample submission must be archival formalinfixed, paraffin-embedded (FFPE) tissue block, or unstained slides sectioned within 45 days from the latest FFPE block, or a fresh biopsy sample obtained during screening but prior to initiation of study treatment. Participants who have received prior treatment with mirvetuximab soravtansine will be required to provide a fresh biopsy sample during screening.\n4. Radiological disease progression on or after the most recent therapy by investigator assessment.\n5. Measurable disease meeting the following criteria (confirmed by central radiographic review, in the Dose-Confirmation Part only):\n\n   * At least one lesion of \\>1.0 centimeter (cm) in long axis diameter for non-lymph nodes or \\>1.5 cm in short axis diameter for lymph nodes that is serially measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 using either computed tomography (CT) or magnetic resonance imaging (MRI),\n   * Lesions that have had external beam radiotherapy (EBRT) or loco-regional therapies such as radiofrequency (RF) ablation must show evidence of PD based on RECIST 1.1 to be deemed a target lesion.\n6. ECOG PS of 0 or 1.\n7. Participants who are expected to survive a minimum of 3 months after the first administration of the study drug.\n8. Adequate renal function as evidenced by serum creatinine less than or equal to (\\\u003C=) 1.5 milligram per deciliter (mg\u002FdL) or calculated creatinine clearance \\>=50 milliliter per (mL) \u002Fminute according to a 12 or 24 hour urine collection.\n\n   For Dose Optimization Part B, adequate renal function as evidenced by calculated creatinine clearance \\>=50 milliliters per minute (mL\u002Fmin) by Cockcroft-Gault formula.\n9. Adequate bone marrow function, as evidenced by:\n\n   * Absolute neutrophil count (ANC) \\>=1.0\\*10\\^9 per liter (\u002FL) (MORAb-202 monotherapy cohorts only)\n   * ANC \\>=1.5\\*10\\^9\u002FL (MORAb-202 plus lenvatinib cohorts)\n   * Hemoglobin (Hgb) \\>=9.0 gram per deciliter (g\u002FdL)\n   * Platelet count \\>=75\\*10\\^9\u002FL Growth factors or transfusions as per institutional practice, are allowed if needed to achieve the above values. Growth factor and platelet transfusion should not be used within 7 days of initiation of study treatment.\n10. Adequate liver function, as evidenced by:\n\n    * Total bilirubin \\\u003C=1.5\\*upper limit of normal (ULN) except for unconjugated hyperbilirubinemia (example, Gilbert's syndrome)\n    * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C=3\\*ULN (in the case of liver metastases \\\u003C=5\\*ULN). Participants with Alkaline Phosphatase (ALP) \\\u003C=3\\*ULN unless they and are known to have bone metastases in which case higher ALP values will also be allowed.\n    * Albumin \\>3.0 g\u002FdL.\n11. Participants must undergo a washout period required from the end of prior treatment to the first administration of the study drug that will be as follows:\n\n    Prior anticancer therapy:\n    * Prior chemotherapy, surgical therapy, radiation therapy: \\>3 weeks. Prior chest radiotherapy or pneumonectomy is an exclusion.\n    * Antibody and other biologic therapeutic agents: \\>=4 weeks.\n    * Endocrine therapy or, small-molecule targeted therapy: \\>2 weeks.\n    * Immunotherapy \\>=4 weeks.\n12. Participants with a history of deep vein thrombosis (DVT) within 3 months of enrollment must be on a stable dose of anticoagulation as demonstrated by appropriate laboratory parameters (depending on the anticoagulant agent) for a minimum of 2 weeks before to starting study treatment. Anticoagulation must continue while on study treatment.\n13. Participants at risk for DVT secondary to central venous catheters or with past medical history of DVT or clinical symptoms suggestive of DVT must have venous Doppler ultrasonography to rule out DVT during the screening period and before to initiation of study treatment.\n14. If a participant has undergone major surgery, the participant must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting study treatment.\n15. Resolution of anticancer therapy-related or radiation-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy (Grade \\\u003C=2), anemia (\\[haemoglobin\\] Hgb \\>=9.0 g\u002FdL), and alopecia (any grade).\n16. Participant must be willing and able to comply with all aspects of the protocol.\n17. Participant must provide written informed consent prior to any study-specific screening procedures.\n18. For cohorts where MORAb-202 is used in combination with lenvatinib: Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP \\\u003C=150\u002F90 millimeter of mercury (mm Hg) and no change in antihypertensive medications within 1 week before the first administration of the study drug.\n\nExclusion Criteria:\n\n1. Participants with endometrial leiomyosarcoma, endometrial stromal sarcoma or other soft tissue sarcoma histology.\n2. Participants who received previous treatment with any folate receptor targeting agents, except for mirvetuximab soravtansine in the setting of FRA \\>=75%.\n3. Participants with platinum refractory ovarian cancer (defined as disease progression during the initial platinum-based chemotherapy treatment).\n4. Currently enrolled in another clinical study or used any investigational drug or device, which in the opinion of the Sponsor may interfere with the study treatment, within the past 28 days or 5 times the half-life (where prior drug therapy falls under the parameters these Inclusion Criteria should be followed) of any investigational drug preceding informed consent.\n5. Participants with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 2 weeks before starting treatment in this study. Brain metastases must be stable for at least 4 weeks on 2 consecutive scans of the brain before starting study treatment.\n6. Diagnosed with meningeal carcinomatosis.\n7. Any other invasive malignancy that required treatment (other than definitive surgery) or has shown evidence of recurrence\u002Fprogression (except for non-melanoma skin cancer, or histologically confirmed complete excision of carcinoma in situ) during the 2 years prior to starting study treatment.\n8. Significant cardiovascular impairment. History within 6 months prior to the first dose of study drug of: congestive heart failure greater than New York Heart Association (NYHA) Class II); unstable angina; myocardial infarction; stroke; cardiac arrhythmia associated with hemodynamic instability.\n\n   In addition, for participants enrolled in the MORAb-202 plus lenvatinib cohorts, significant cardiovascular impairment also includes: History of arterial thromboembolism within 12 months of starting study treatment; Left ventricular ejection fraction (LVEF) \\\u003C50% or below the institutional normal range determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).Note: Medically controlled arrhythmia is permitted.\n9. Clinically significant ECG abnormality, including marked prolonged baseline QT as corrected using Fridericia's formula (QTcF) (repeated demonstration of a QTcF interval \\>500 milliseconds \\[ms\\]). A history of risk factors for torsade de pointes (example, heart failure, hypokalemia, family history of long QT Syndrome) or the use of concomitant medications that prolong the QTcF.\n\n   For participants enrolled in the MORAb-202 plus lenvatinib cohorts, prolongation of the QTcF interval to \\>480 ms.\n10. Known to be Human Immunodeficiency Virus (HIV) positive. Testing at entry not required.\n11. Active viral hepatitis (B or C as demonstrated by positive serology). Testing at entry if there are no symptoms or history is not required unless as per local requirements.\n12. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta human chorionic gonadotropin \\[ß-hCG\\] or human chorionic gonadotropin \\[hCG\\]) with a minimum sensitivity of 25 International units per liter (IU\u002FL) or equivalent units of ß-hCG \\[or hCG\\]. A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first administration of the study drug.\n13. Females of childbearing potential who\n\n    * within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:\n\n      * total abstinence (if it is their preferred and usual lifestyle)\\*\n      * an intrauterine device or intrauterine hormone-releasing system (IUS)\n      * a contraceptive implant\n      * combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) or progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable). Participants using an oral contraceptive (participant must be on a stable dose of the same oral contraceptive product for at least 28 days before dosing and throughout the study and for 7 months (5\\*half-life plus 180 days) after study drug discontinuation)\n      * bilateral tubal occlusion\n      * have a vasectomized partner with confirmed azoospermia\n    * do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 7 months (5\\*half-life plus 180 days) after study drug discontinuation.\n\n    For sites outside of the EU, it is permissible that if a highly effective method of contraception is not appropriate or acceptable to the participant, then the participant must agree to use a medically acceptable method of contraception, that is, double-barrier methods of contraception such as latex or synthetic condom plus diaphragm or cervical\u002Fvault cap with spermicide. NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (that is, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).\n\n    \\*Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study intervention. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.\n14. For Dose-Escalation only: Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria above (that is, not of childbearing potential or practicing highly effective contraception throughout the study period and for 7 months (5\\*half-life plus 180 days) after study drug discontinuation). If the female partner is pregnant, then males who do not agree to use latex or synthetic condoms throughout the study period and for 4 months (5\\*half-life plus 90 days) after study drug discontinuation. No sperm donation is allowed during the study period and for 4 months (5\\*half-life plus 90 days) after study drug discontinuation.\n15. Pulmonary Function Test (PFT) abnormalities: FEV1\u002FFVC \\\u003C0.7, FEV1 or FVC \\\u003C80%, DLCO \\\u003C80% or less than the lower limit of normal according to local institutional standards.\n16. Current ILD\u002Fpneumonitis, or ILD\u002Fpneumonitis is suspected at Screening or history of interstitial lung disease (ILD)\u002Fpneumonitis of any severity including ILD\u002Fpneumonitis from prior anticancer therapy.\n17. Current infectious pneumonia, history of viral pneumonia (including COVID-19-related infection) with evidence of persistent radiologic abnormalities.\n18. Lung-specific clinically significant illnesses including, but not limited to any underlying pulmonary disorder (example, pulmonary embolism), asthma, chronic obstructive pulmonary disease (COPD), and restrictive lung disease, or currently receiving any medication that is associated with a clinically significant risk of developing ILD.\n19. Clinically significant pleural or pericardial effusion requiring drainage or ascites requiring peritoneal shunt.\n20. Prior pneumonectomy.\n21. History of chest radiotherapy. Participants with history of chest wall radiation (example, history of breast cancer) may be permitted if chest wall radiation is documented \\> 2 years before starting study treatment.\n22. Any autoimmune, connective tissue, or inflammatory disorders (example, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc) where there is documented (or suspicion of) pulmonary involvement.\n23. A known history of active TB (bacillus tuberculosis).\n24. Scheduled for surgery during the study, other than minor surgery which would not delay study treatment.\n25. An active clinically significant (in the opinion of the Investigator) infection requiring systemic therapy within 2 weeks prior to the first dose of study drug.\n26. Administration of a live, attenuated vaccine within 4 weeks prior to the first dose of study drug, or anticipation that such a live attenuated vaccine will be required during the study. Inactivated vaccines (such as hepatitis A or polio vaccines) are permitted during the study. Seasonal influenza and COVID-19 vaccines that do not contain live virus are permitted.\n27. Any prior hypersensitivity to monoclonal antibodies or contraindication to the receipt of corticosteroids or any of the excipients (investigators should refer to the prescribing information for the selected corticosteroid).\n28. Known intolerance to either of the components of the study drug.\n29. Any medical or other condition which, in the opinion of the investigator would preclude the participants participation in the clinical study.\n30. Receiving any medication prohibited in combination with the study treatment(s) as described in the product label for eribulin, unless medication was stopped within 7 days prior to enrollment.\n31. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n\n    Dose Optimization Part B participants who receiving MORAb-202 in combination with lenvatinib:\n32. \\>1+ proteinuria on dipstick, 24-hour urine protein is \\>=1 gram.\n33. Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib.\n34. Unable to take oral medication.\n35. Major surgery within 3 weeks before the first dose of study treatment. Note: adequate wound healing after major surgery must be assessed clinically and independent of time elapsed for eligibility.\n36. Serious nonhealing wound, ulcer or bone fracture.\n37. Pre-existing Grade \\>=3 gastrointestinal (GI) or non-GI fistula.\n38. Radiographic evidence of major blood vessel invasion\u002Finfiltration. The degree of tumor invasion \u002F infiltration of major blood vessels should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage\u002Fnecrosis following lenvatinib therapy.",{"count":121,"type":21},182,[24,123],"PHASE2","The primary objectives of the study are: (1) in the dose-escalation part: to evaluate safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of farletuzumab ecteribulin (MORAb-202) in participants with selected tumor types (ovarian cancer \\[OC\\], endometrial cancer \\[EC\\], non-small cell lung carcinoma \\[NSCLC\\], triple-negative breast cancer \\[TNBC\\]), and (2) in dose-confirmation part: to evaluate preliminary efficacy measured by objective response rate (ORR) of farletuzumab ecteribulin (MORAb-202) in participants with OC and EC at selected doses and to further evaluate the safety and tolerability of farletuzumab ecteribulin (MORAb-202) and (3) dose-optimization part. (divided in two parts: Part A \\[OC and EC participants\\] and Part B \\[OC only\\]): Part A: to evaluate other farletuzumab ecteribulin (MORAb-202) treatment regimens for safety, tolerability and preliminary efficacy in participants with OC and EC; to evaluate the addition of short course of oral corticosteroids following every dose of farletuzumab ecteribulin (MORAb-202) administered every 21 days; and to select treatment regimens with farletuzumab ecteribulin (MORAb-202) for further evaluation in Part B. Part B: to evaluate the safety and tolerability of different doses of farletuzumab ecteribulin (MORAb-202) as monotherapy and in combination with lenvatinib and to determine the recommended dose (RD) of farletuzumab ecteribulin (MORAb-202) as monotherapy and in combination with lenvatinib.",[126],"Solid Tumor",[128,129,130,131,132,133,134,135,136,137],"Lenvatinib","Farletuzumab ecteribulin","Neoplasms","Endometrial Neoplasms","Triple-Negative Breast Cancer","Endometrial Carcinoma","Carcinoma, Non-Small-Cell Lung","Adenocarcinoma","Ovarian Neoplasms","Folate Receptor Alpha (FRA)","RECRUITING","2026-06-03",{"date":141,"type":32},"2026-06-04",{"date":143,"type":32},"2020-08-06",{"date":145,"type":21},"2030-08-08",{"name":38,"class":39},58,{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":22,"phases":157,"briefSummary":158,"conditions":159,"keywords":161,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},"100630868","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-e2086-in-adults-with-narcolepsy-100630868","NCT07493265","A Study to Evaluate the Efficacy and Safety of E2086 in Adults With Narcolepsy","A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of E2086 in Adults With Narcolepsy","Inclusion Criteria:\n\nParticipants must meet all of the following criteria to be included in this study:\n\n1. Male or female, age greater than or equal to (\\>=) 18 years (or as regionally appropriate) at the time of informed consent\n2. NT1 Cohort: Must fulfill Inclusion Criteria 2a and 2b\n\n   1. Diagnosis of NT1 within the last 10 years of screening, as confirmed by at least one of the following:\n\n      * Polysomnography (PSG) and Multiple Sleep Latency Test (MSLT) results, and clinical history, consistent with the 2023 International Classification of Sleep Disorders, 3rd edition, text revision (ICSD-3-TR) criteria for NT1\n      * Cerebrospinal fluid orexin-A\u002Fhypocretin-1 concentration less than or equal to (\\\u003C=) 110 picograms per milliliter (pg\u002FmL)\n   2. At least 4 or more episodes of cataplexy\u002Fweek as averaged over 2 weeks minimum and confirmed by the cataplexy portion of the Diary If PSG or MSLT results are not available within the last 10 years of screening to fulfill Criterion 2a then screening assessment results for PSG or MSLT can be used instead\n3. NT2 Cohort: Diagnosis of NT2 within the last 10 years of screening, as confirmed by PSG and MSLT results, and clinical history, consistent with the 2023 ICSD-3-TR criteria for NT2 If PSG or MSLT results are not available within the last 10 years of screening to fulfill Criterion 3 then screening assessment results for PSG or MSLT can be used instead\n4. ESS score \\>=10\n5. Reports regular bedtime, defined as the time that the participant attempts to sleep, between 22:00 and 01:00 (based on data from the screening Diary)\n6. Reports regular waketime, defined at the time the participant gets out of bed for the day, between 05:00 and 10:00 (based on data from the screening Diary)\n7. Reports being in bed between 7 and 9 hours per night (based on data from the sleep portion of the Diary)\n8. Compliance rate \\>=80 percentage (%) for completion of the Diary during screening\n9. Body mass index (BMI) \\>=18 to less than (\\\u003C) 35 kilograms per square meter (kg\u002Fm\\^2) at Screening\n\nExclusion Criteria:\n\n1. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin \\[ß-hCG\\] (or human chorionic gonadotropin \\[hCG\\]) test with a minimum sensitivity of 25 international units per liter (IU\u002FL) or equivalent units of ß-hCG \\[or hCG\\]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug\n2. Females of childbearing potential who:\n\n   * Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:\n\n     1. total abstinence (if it is their preferred and usual lifestyle)\n     2. an intrauterine device or intrauterine hormone-releasing system (IUS)\n     3. a contraceptive implant\n     4. Combined estrogen and progestogen-containing hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception associated with inhibition of ovulation, such as desogestrel (oral, injectable). Participants using hormonal contraceptives must be on a stable dose of the same contraceptive product for at least 28 days before dosing, throughout the study and for at least 28 days following study drug discontinuation\n     5. have a vasectomized partner with confirmed azoospermia\n   * Do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after study drug discontinuation.\n\n   Participants on an oral contraceptive must use an additional study method throughout the study and for 28 days after study drug discontinuation. For sites outside of Europe, it is permissible that if a highly effective method of contraception is not appropriate or acceptable to the participant, then the participant must agree to use a medically acceptable method of contraception, that is, double-barrier methods of contraception such as latex or synthetic condom plus diaphragm or cervical\u002Fvault cap with spermicide.\n\n   NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (that is, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).\n3. Clinically significant illness that requires medical treatment within 8 weeks of dosing or a clinically significant infection that requires medical treatment within 4 weeks of dosing\n4. Evidence of disease that may influence the outcome of the study within 4 weeks before dosing (for example, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system)\n5. Any history of surgery that may affect PK profiles of E2086 (for example, hepatectomy, nephrectomy, digestive organ resection) or who have a congenital abnormality in metabolism at Screening\n6. Any clinically abnormal symptom or organ impairment found by medical history at Screening, including severe renal impairment (estimated glomerular filtration rate \\[eGFR\\] \\\u003C30 milliliters per minute (mL\u002Fmin), and physical examinations, vital signs, ECG findings, or laboratory test results that require medical treatment at Screening or Baseline\n7. A prolonged QTc interval calculated using Fridericia's formula (QTcF) greater than 450 milliseconds (ms) according to central reading at Screening or Baseline. If the QTcF machine read is greater than 450 ms on the first single 12-lead ECG, 2 additional 12-lead ECGs will be performed 1 minute apart and the mean of the 3 QTcF values will be calculated\n8. Persistent systolic BP greater than (\\>) 130 or \\\u003C100 millimeters of mercury (mmHg) or diastolic BP \\>85 or \\\u003C50 mmHg at Screening (based on BP measured on at least 3 occasions over 2 weeks), or at Baseline. If outside of these limits at Screening or Baseline, BP should be repeated twice with at least 5 minutes between measurements\n9. Persistent HR less than 50 beats\u002Fmin or more than 100 beats\u002Fmin at Screening (based on HR measured on at least 3 occasions over 2 weeks), or at Baseline. If outside of these limits at Screening or Baseline, HR should be repeated twice with at least 5 minutes between measurements\n10. Any lifetime history of suicidal behavior as indicated by the C-SSRS\n11. Current unstable psychiatric disorder, current active major depressive episode or an active major depressive episode in the past 6 months\n12. Any suicidal ideation with intent with or without a plan at Screening or within 6 months of Screening (that is, answering \"Yes\" to questions 4 or 5 on the Suicidal Ideation section of the C-SSRS)\n13. Psychotic disorder(s) or unstable recurrent affective disorder(s) evident by use of antipsychotics within 2 years before Screening\n14. Hypersensitivity to the study drug or any of the excipients\n15. Intake of herbal preparations containing St. John's Wort within 5x the half-life before dosing\n16. Any history of or concomitant medical condition that in the opinion of the investigator(s) would compromise the participant's ability to safely complete the study\n17. Planned surgery that requires general, spinal, or epidural anesthesia that would take place during the study. Planned surgery which requires only local anesthesia and that can be undertaken as a day case without inpatient stay postoperatively need not result in exclusion if in the opinion of the investigator this operation does not interfere with study procedures and participant safety\n18. Known to be human immunodeficiency virus (HIV) positive\n19. Acute Epstein Barr virus (EBV) infection with a positive EBV Viral Capsid Antigen Antibody (VCA) IgM at Baseline\n20. Known to be hepatitis B virus (HBV)-positive with a detectable HBV (for example, hepatitis B surface antigen \\[HBsAg\\] reactive) within 6 months before the 1st dose of study drug, or hepatitis C virus (HCV) positive with a detectable (for example, HCV ribonucleic acid (RNA) \\[qualitative\\]) viral load. Note: Participants who are HCV positive due to prior resolved disease can be enrolled, only if a confirmatory negative HCV RNA test is obtained and the participant has completed active treatment\n21. Initiation of statin therapy, or a change to a different statin, or an increase in the dose of a statin within the 6 months before the planned start of study drug\n22. History of formally diagnosed moderate to severe obstructive sleep apnea (OSA)\n23. Current use of continuous positive airway pressure (CPAP), hypoglossal nerve stimulator, oral device, or other therapy for the treatment of OSA\n24. Symptomatic restless legs syndrome\n25. Apnea-hypopnea index \\>=15 on Screening PSG\n26. Use of anticataplectic medications (including but not limited to antidepressants) within 5× the half-life before Screening\n27. Use of psychostimulant medications, prescription and over-the-counter (OTC), within 5× the half-life before Screening until after the Follow-Up Visit. Examples of prohibited medications include OTC stimulants (for example, pseudoephedrine), methylphenidate, amphetamines, modafinil, armodafinil, sodium oxybate, pitolisant, solriamfetol, and pemoline\n28. Use of sleep promoting or sedating medications, prescription and OTC, within 5x the half-life before Screening until after the Follow-Up Visit. Examples of prohibited medication include OTC sleep aids, trazodone, hypnotics, benzodiazepines, barbiturates,cannabinoids, melatonin, melatonin receptor agonists, dual orexin receptor antagonists, and opioids\n29. Inability to discontinue use of strong (such as antifungal itraconazole and antibiotic clarithromycin) and moderate (such as antifungal fluconazole) Cytochrome P450 3A (CYP) 3A inhibitors within 5x the half-life before dosing until after the Follow-Up Visit\n30. Inability to discontinue use of CYP3A inducers (such as antibiotic rifampicin and anti-convulsant phenytoin) within 5x the half-life before dosing until after the Follow-Up Visit\n31. History of drug or alcohol dependency or abuse within 2 years before Screening, or those who have a positive urine drug test or breath (or urine) alcohol test at Screening or Baseline\n32. Does not agree to abstain from use of recreational drugs during the study\n33. Currently enrolled in another clinical study or used any investigational drug or device within 28 days or 5x the half-life, whichever is longer, preceding informed consent\n34. Receipt of blood products within 4 weeks of dosing, donation of blood within 8 weeks of dosing, or donation of plasma within 1 week of dosing\n35. Past participation in a study of an orexin agonist if discontinuation of orexin agonist use was related to an adverse drug reaction or inefficacy",{"count":156,"type":21},64,[123],"The primary purpose of this study is to evaluate the optimal doses of E2086 compared to placebo in participants with narcolepsy for reduction of excessive daytime sleepiness (EDS) as assessed by Mean Sleep Latency (MSL) (measured from the first 4 maintenance of wakefulness tests \\[MWTs\\]).",[160],"Narcolepsy",[162,163,164],"Narcolepsy type 1 (NT1)","Narcolepsy type 2 (NT2)","E2086","2026-05-11",{"date":167,"type":32},"2026-05-14",{"date":169,"type":32},"2026-03-26",{"date":171,"type":21},"2027-03-01",{"name":38,"class":39},57,{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":16,"minAge":181,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":97,"phases":4,"briefSummary":182,"conditions":183,"keywords":186,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":195,"locationsCount":196},"100397635","extended-access-program-with-lorcaserin-for-the-treatment-of-dravet-syndrome-and-other-refractory-epilepsies-100397635","NCT04457687","Extended Access Program With Lorcaserin For The Treatment of Dravet Syndrome and Other Refractory Epilepsies","Extended Access Program and Retrospective Chart Review for Lorcaserin in Dravet Syndrome and Other Refractory Epilepsies","Inclusion Criteria:\n\n1. Confirmed diagnosis of Dravet syndrome (according to Recommendation from a North American Consensus Panel, 2017) or other refractory epilepsy (per the judgment of the treating physician)\n2. Male or female, age at least 2 years at the time of informed consent\n3. Currently treated with lorcaserin, that the treatment is for Dravet syndrome or other refractory epilepsies, and the treatment was initiated before 13 Feb 2020; or has completed Study E2023-A001-304\n4. Has a clinical benefit from lorcaserin in the opinion of the treating physician\n\nExclusion Criteria:\n\nNone","2 Years","The primary purpose of this study is to provide continued access of lorcaserin to participants with Dravet syndrome and other refractory epilepsies.",[184,185],"Epilepsies, Myoclonic","Drug Resistant Epilepsy",[187,188,189,190,191],"Extended Access Program","Expanded Access Program","Dravet Syndrome","Refractory Epilepsies","Lorcaserin","2025-01-28",{"date":194,"type":32},"2025-01-30",{"name":38,"class":39},22,""]