[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Alkermes, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":219},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,47,75,103,129,153,176,196],{"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":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100462546","phase-3-study-to-evaluate-weight-gain-as-assessed-by-change-in-bmi-z-score-in-pediatric-subjects-with-schizophrenia-or-bipolar-i-disorder-100462546",false,"NCT05303064","Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder","A Phase 3, Randomized, Double-Blind, 52-Week Study of OLZ\u002FSAM vs Olanzapine to Evaluate Weight Gain as Assessed by Change in BMI Z-Score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder (ENLIGHTEN-Youth)","Inclusion Criteria:\n\n* Subjects aged 13 to 17 years with schizophrenia or aged 10 to 17 years with bipolar I disorder, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria\n* Subject is an outpatient or will be able to be treated on an outpatient basis (per Investigator judgement) by study Week 2\n* Subject has reliable family\u002Flegal guardian support available for outpatient management\n* Subject is either currently treated with olanzapine, or if treated with another antipsychotic, the subject has had an inadequate response (eg, unsatisfactory clinical response, AEs, or nonadherence to current medication) based on Investigator judgment\n* Subject must not be a danger to self or others (per Investigator judgement)\n\nExclusion Criteria:\n\n* Subject presents with a major depressive episode(bipolar I disorder) or other neuropsychiatric diagnosis (according to DSM-5 criteria) including schizoaffective disorder, current major depressive disorder that is untreated and\u002For unstable, or any other psychiatric condition that could interfere with participation in the study\n* Subject has a history of seizure disorder (exception: history of febrile seizures), severe head trauma with loss of consciousness within the 12 months prior to Screening, or other clinically significant neurological condition within the 12 months prior to Screening\n* Subject poses a current suicide risk as assessed by the Investigator or as confirmed by the baseline Columbia-Suicide Severity Rating Scale (C-SSRS)\n* Subject has received olanzapine for \\>= 14 days during the month prior to screening, or has a history of poor or inadequate response to treatment with olanzapine\n* Subject has taken opioid agonists within 14 days prior to Screening, or within 30 days prior to Screening (for long-acting opioid agonists)\n* Subject anticipates needing to take opioid medication during the study period (eg, planned surgery, including oral surgery)\n* Subject has taken opioid antagonists including naltrexone (any formulation) or naloxone within 60 days prior to Screening\n* Subject has used a long-acting injectable antipsychotic medication within 3 injection cycles prior to Screening\n* Subject has a BMI percentile \\>98th or \\\u003C5th\n* Subject has a diagnosis of diabetes mellitus or presents with prediabetes lab results at Screening (hemoglobin A1c \\[HbA1c\\] \\>= 6%)\n* Subject has started a smoking cessation program within the 6 months prior to Screening or has joined a weight management program or has had significant changes in diet or exercise regimen within 6 weeks prior to Screening\n* Subject has participated in a clinical study of an investigational product within the last 30 days prior to Screening","ALL","10 Years","17 Years",{"count":20,"type":21},220,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","To compare changes in body mass index (BMI) Z-score following treatment with OLZ\u002FSAM vs olanzapine",[27,28],"Schizophrenia","Bipolar I Disorder",[30,27,28,31,32,33],"LYBALVI","Pediatric","Olanzapine","Samidorphan","RECRUITING","2026-08-12",{"date":37,"type":38},"2026-08-14","ACTUAL",{"date":40,"type":38},"2022-06-30",{"date":42,"type":21},"2026-09",{"name":44,"class":45},"Alkermes, Inc.","INDUSTRY",47,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100651060","a-study-to-evaluate-safety-and-efficacy-of-alks-7290-compared-with-placebo-in-adult-participants-with-attention-deficit-hyperactivity-disorder-alks-7290-201-100651060","NCT07755410","A Study to Evaluate Safety and Efficacy of ALKS 7290 Compared With Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder (ALKS 7290-201)","A Phase 2, Randomized, Parallel-Group, Double-Blind, Study to Evaluate the Safety and Efficacy of ALKS 7290 Compared to Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder","Inclusion Criteria:\n\n* Meets the Diagnostic and Statistical Manual of Mental Disorders -5 criteria for ADHD, as confirmed by the Mini-International Neuropsychiatric Interview (MINI) for ADHD Studies 7.0.2.\n* Is otherwise healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring. Participants must be stable on permitted medication for 2 months prior to first visit, without anticipated changes to dose.\n* AISRS total score of ≥26\n* CGI-S score ≥ 4 (moderately ill or worse)\n* Has a Body Mass Index within 18 to 35 kg\u002Fm2\n\nExclusion Criteria:\n\n* Has a known history of intellectual developmental disorder or cognitive impairment that, in the opinion of the Investigator, would interfere with study participation.\n* Has any of the following psychiatric conditions per the DSM-5 criteria, as assessed by the MINI. Conditions not assessable by the MINI should be assessed by clinical judgement; Diagnosis of schizophrenia, schizoaffective disorder, or bipolar I or II disorder, or current, unstable, MDD or GAD.\n* Clinically significant cognitive difficulties including dementia, delirium or amnestic syndromes, or any other cognitive disorder present with the past 2 years that could interfere with participation in the study.\n* Moderate to severe substance use disorder according to DSM-5 guidelines, including use of alcohol, nicotine, cannabis, narcotics, or any illicit substance.\n* Any other psychiatric condition that could interfere with participation in the study.","18 Years","65 Years",{"count":57,"type":21},312,[59],"PHASE2","The purpose of this study is to measure safety and the improvement in symptoms in subjects with ADHD when taking ALKS 7290 tablets compared with placebo tablets.",[62],"Attention Deficit Disorder With Hyperactivity (ADHD)",[64,65],"ADHD","Attention Deficit Disorder with Hyperactivity","2026-08-05",{"date":68,"type":38},"2026-08-10",{"date":70,"type":21},"2026-08",{"date":72,"type":21},"2027-07",{"name":44,"class":45},2,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":100,"leadSponsor":101,"locationsCount":102},"100634531","phase-3-a-study-to-evaluate-the-efficacy-safety-and-tolerability-of-alks-2680-in-adults-with-narcolepsy-type-1-brilliance-nt1---304-100634531","NCT07540897","A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 Study 304)","Inclusion Criteria:\n\n* Meets the diagnostic criteria of NT1 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG\u002FMSLT\\* or CSF hypocretin-1 level)\n\nExclusion Criteria:\n\n* Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle.\n* Has a history or presence at Visit 1 of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise participant safety, interfere with any study assessment, or affect the participant's ability to complete the study.\n* Is currently enrolled in another interventional clinical trial or has received any investigational drug or used any interventional investigational device within 30 days prior to Visit 1. Participants previously enrolled in Study ALKS 2680-201 are not eligible for enrollment.\n* Is currently pregnant, breastfeeding, or is planning to become pregnant during the study.","70 Years",{"count":84,"type":21},150,[24],"The purpose of this study is to measure decreases in daytime sleepiness, cataplexy (sudden loss of muscle tone), and disease symptoms in participants with NT1 when taking ALKS 2680 tablets compared with placebo tablets.",[88],"Narcolepsy Type 1",[88,90,91,92,93,94,95,96],"NT1","Alixorexton","Sleepiness","Orexin-2","Orexin-2 receptor agonist","sleep disorder","excessive daytime sleepiness",{"date":98,"type":38},"2026-08-07",{"date":70,"type":21},{"date":72,"type":21},{"name":44,"class":45},14,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":82,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},"100631573","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-alks-2680-in-adults-with-narcolepsy-type-2-100631573","NCT07502443","A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2 (Brilliance NT2 Study 303)","Brilliance NT2","Inclusion Criteria:\n\n* Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including the following: lifestyle considerations and restrictions, adherence to contraception guidance, adherence to actigraphy and diary requirements, if receiving treatment for OSA, adherence to primary OSA therapy over the 30 days prior to Visit 1, and throughout the study, including during overnight visits.\n* Meets the diagnostic criteria of NT2 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG\u002FMSLT).\n\nExclusion Criteria:\n\n* Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle.\n* Has a history or presence of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise participant safety, interfere with any study assessment, or affect the participant's ability to complete the study.\n* Is currently enrolled in another interventional clinical trial or has received any investigational drug or used any interventional investigational device within 30 days prior to Visit 1. Participants previously enrolled in Study ALKS 2680-202 are not eligible for enrollment.\n* Is currently pregnant, breastfeeding, or is planning to become pregnant during the study",{"count":112,"type":21},176,[24],"The purpose of this study is to measure decreases in daytime sleepiness, and disease symptoms in participants with Narcolepsy Type 2 (NT2) when taking ALKS 2680 tablets compared with placebo tablets.",[116],"Narcolepsy Type 2",[116,118,119,120,121,96],"NT2","Sleep","Sleep disorder","orexin-2 receptor agonist",{"date":98,"type":38},{"date":124,"type":38},"2026-04-22",{"date":126,"type":21},"2027-06",{"name":44,"class":45},28,{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":82,"enrollmentInfo":137,"targetDuration":4,"studyType":22,"phases":138,"briefSummary":86,"conditions":139,"keywords":140,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":147,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":151,"locationsCount":152},"100627957","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-alks-2680-in-adults-with-narcolepsy-type-1-100627957","NCT07455383","A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 Study 302)","Brilliance NT1","Inclusion Criteria:\n\n* Meets the diagnostic criteria of NT1 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG\u002FMSLT\\* or CSF hypocretin-1 level).\n\nExclusion Criteria:\n\n* Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle.\n* Has a history or presence at Visit 1 of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise participant safety, interfere with any study assessment, or affect the participant's ability to complete the study.\n* Is currently enrolled in another interventional clinical trial or has received any investigational drug or used any interventional investigational device within 30 days prior to Visit 1. Participants previously enrolled in Study ALKS 2680-201 are not eligible for enrollment.\n* Is currently pregnant, breastfeeding, or is planning to become pregnant during the study",{"count":84,"type":21},[24],[88],[141,142,88,143,144,145,146,91,94,96],"Brillance","Narcolepsy","Sleep Disorders","Fatigue","Cataplexy","ALKS 2680",{"date":98,"type":38},{"date":149,"type":38},"2026-04-06",{"date":126,"type":21},{"name":44,"class":45},29,{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":82,"enrollmentInfo":160,"targetDuration":4,"studyType":22,"phases":162,"briefSummary":163,"conditions":164,"keywords":166,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":169,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":175},"100575084","phase-2-a-long-term-study-of-alks-2680-in-subjects-with-narcolepsy-and-idiopathic-hypersomnia-100575084","NCT06767683","A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia","An Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Durability of Treatment Effect of ALKS 2680 in Subjects With Narcolepsy Type 1 and Type 2 and Idiopathic Hypersomnia","Inclusion Criteria:\n\n* Was eligible for and has completed end of treatment visit of ALKS 2680 eligible parent study in NT1, NT2 or IH. The current eligible studies are ALKS 2680-201 (Vibrance-1), ALKS 2680-202 (Vibrance-2) and ALKS 2680-203 (Vibrance-3)\n* Is willing and able, and in the opinion of the treating physician can safely discontinue any medications prescribed for the management of narcolepsy symptoms, as applicable, for 5 half-lives prior to Day 1 (for re-entry subjects), and for the duration of study (for all subjects)\n\nExclusion Criteria:\n\n* Developed a new clinically significant health condition, ECG or laboratory abnormality, in the opinion of the Investigator or Sponsor, may impact the subject's participation in the study\n* Is currently pregnant, breastfeeding, or planning to become pregnant during the study\n* Is currently enrolled in another clinical study (other than the parent study) or used any investigational drug or device within 30 days prior to Screening",{"count":161,"type":21},256,[59,24],"The purpose of this study is to continue to measure the safety, tolerability, and durability of treatment effect in subjects with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH) when taking ALKS 2680 tablets.",[88,116,165],"Idiopathic Hypersomnia",[142,88,116,90,118,121,167,95,96,168,165],"sleep","IH",{"date":98,"type":38},{"date":171,"type":38},"2025-01-27",{"date":173,"type":21},"2028-06",{"name":44,"class":45},49,{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":4,"targetDuration":4,"studyType":183,"phases":4,"briefSummary":184,"conditions":185,"keywords":188,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":194,"locationsCount":195},"100650124","an-expanded-access-program-eap-for-olzsam-in-pediatric-participants-with-schizophrenia-or-bipolar-i-disorder-alks-3831-315-100650124","NCT07744113","An Expanded Access Program (EAP) for OLZ\u002FSAM in Pediatric Participants With Schizophrenia or Bipolar I Disorder (ALKS 3831-315)","An Expanded Access Program (EAP) for OLZ\u002FSAM in Pediatric Participants With Schizophrenia or Bipolar I Disorder","Inclusion Criteria:\n\n* The Participant has completed 52-weeks on the ALKS 3831-A313 clinical study.\n* The Participant must not be a danger to self or others (per Investigator judgement) and has family support available to be maintained as an outpatient.\n* The Participant will benefit from continued therapy with OLZ\u002FSAM per the clinical judgment of the Participant's Physician.\n* The Participant can be treated on an outpatient basis.\n* The Participant agrees to abide by the contraception requirements specified in the protocol for the duration of the study.\n* The Participant's parent(s)\u002Flegal guardian(s) is\u002Fare considered reliable by the Physician and has agreed to provide support to the subject to ensure compliance with study treatment, visits, and protocol procedures.\n\nExclusion Criteria:\n\n* The participant is eligible for commercial OLZ\u002FSAM (LYBALVI®) through standard commercial pathways (≥18) for approved use.\n* The participant is at a current risk of suicidal behavior as assessed by the Participant's Physician or answered \"Yes\" to questions 4 or 5 on the C-SSRS and\u002For had a suicide attempt within the past 12 months.\n* The participant has any finding that in the view of the Physician would compromise the safety of the Participant or affect their ability to fulfill the Program requirements.\n* The participant is currently taking medications that are contraindicated with olanzapine or OLZ\u002FSAM use or exhibit drug interaction potential with olanzapine or OLZ\u002FSAM (such as the Participant is currently using opioids or undergoing acute opioid withdrawal).\n* The participant has a positive test for opioids.\n* The participant is currently enrolled in an interventional clinical study or Early (or Expanded) Access Program (other than the OLZ\u002FSAM Program) or used any investigational drug or device (other than the OLZ\u002FSAM) within 30 days prior to starting the Program.\n* The participant has a positive urine pregnancy test, is currently pregnant or breastfeeding, or plans to become pregnant or begin breastfeeding at any point during the Program and for 90 days after any treatment with OLZ\u002FSAM.","EXPANDED_ACCESS","To provide continued access to OLZ\u002FSAM for pediatric participants with schizophrenia or bipolar I disorder who have completed participation in the ALKS 3831-A313 long-term safety extension study.",[186,187],"Bipolar 1 Disorder","Schizophrenia Disorder",[32,31,30,189],"Samidorphin","AVAILABLE","2026-07-29",{"date":193,"type":38},"2026-08-04",{"name":44,"class":45},1,{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":202,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":82,"enrollmentInfo":204,"targetDuration":4,"studyType":22,"phases":206,"briefSummary":207,"conditions":208,"keywords":209,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":218},"100580921","phase-2-a-study-to-evaluate-the-safety-and-effectiveness-of-alks-2680-in-subjects-with-idiopathic-hypersomnia-100580921","NCT06843590","A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia","A Phase 2, Randomized, Parallel-Group, Double-Blind, Dose-Range-Finding Study to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Idiopathic Hypersomnia (Vibrance-3)","Vibrance-3","Inclusion Criteria:\n\n* Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including: lifestyle considerations and restrictions, adherence to contraception guidance, adherence to actigraphy and diary requirements, if receiving treatment for OSA, adherence to primary OSA therapy over the 30 days prior to Visit 1, and throughout the study, including during overnight visits.\n* Meets the diagnostic criteria of Idiopathic Hypersomnia according to ICSD-3-TR guidelines, confirmed by the diagnostic evaluations (PSG\u002FMSLT\u002Factigraphy) within the previous 10 years\n\nExclusion Criteria:\n\n* Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle\n* Has a history or presence at Visit 1 of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise subject safety, interfere with any study assessment, or affect the subject's ability to complete the study\n* Is currently enrolled in another clinical study or used any investigational drug or device within 30 days prior to Visit 1\n* Is currently pregnant, breastfeeding, or is planning to become pregnant during the study",{"count":205,"type":21},126,[59],"The purpose of this study is to measure the safety and decrease in daytime sleepiness in subjects with Idiopathic Hypersomnia when taking ALKS 2680 tablets compared with placebo tablets",[165],[165,168,167,95,121,96],"2026-06-22",{"date":212,"type":38},"2026-06-24",{"date":214,"type":38},"2025-05-22",{"date":216,"type":21},"2026-11",{"name":44,"class":45},50,""]