[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653514":3},{"organization":4,"outcomesModule":7,"designInfo":47,"detailedDescription":11,"studyPopulation":11,"armGroups":53,"interventions":60,"overallOfficials":11,"centralContacts":67,"locations":11,"responsibleParty":73,"collaborators":11,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":11,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":11,"enrollmentInfo":84,"targetDuration":11,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":96,"whyStopped":11,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":11},{"fullName":5,"class":6},"Otsuka Pharmaceutical Development & Commercialization, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation",null,"Throughout the trial (up to Week 27)",[14,18],{"measure":15,"description":16,"timeFrame":17},"Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score","The HAM-A is a clinician-administered rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is scored on a 5-point Likert-type scale ranging from 0 (absent) to 4 (very severe). The total score ranges from 0 to 56, with higher scores indicating greater severity.","Baseline, Weeks 8, 14, and 26",{"measure":19,"description":20,"timeFrame":17},"Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score","The CGI-S is a clinician-rated assessment of the participant's current illness state on a 7-point Likert-type scale (1=normal, not at all ill; 7=among the most extremely ill participants), where a higher score is associated with greater illness severity. A decrease in value indicates improvement.",[22,25,29,32,34,38,41,44],{"measure":23,"description":11,"timeFrame":24},"Percentage of Participants With Any Change in Laboratory Tests Values From Baseline","Baseline, Weeks 8, 20, and 26",{"measure":26,"description":27,"timeFrame":28},"Percentage of Participants With Any Change in Potentially Clinically Relevant Vital Signs From Baseline","Vital signs including blood pressure, heart rate and body temperature will be recorded.","From Baseline up to Week 26",{"measure":30,"description":11,"timeFrame":31},"Percentage of Participants With Any Change From Baseline in Weight, Body Mass Index (BMI) and Waist Circumference","Baseline, Weeks 8 and 26",{"measure":33,"description":11,"timeFrame":28},"Percentage of Participants With Any Change From Baseline in 12-Lead Electrocardiogram (ECG)",{"measure":35,"description":36,"timeFrame":37},"Number of Participants With Changes in Frequency and Severity of Suicidal Ideation and Suicidal Behavior as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)","The C-SSRS is a clinician administered, interview-based rating scale which systematically assesses suicidal ideation, suicidal behavior and non-suicidal self-injurious behavior. The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, suicidal behavior, completed suicide), suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan and intent) and non-suicidal self-injurious behavior.","Up to Week 26",{"measure":39,"description":40,"timeFrame":17},"Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)","The AIMS total score commonly uses the sum of items 1-7 and ranges from 0 to 28 (0 = no abnormal movements; 28 = maximum severity on rated items); higher scores indicate more severe abnormal involuntary movements (worse outcome). A higher total score indicates more frequent or severe involuntary movements across multiple muscle groups.",{"measure":42,"description":43,"timeFrame":17},"Change From Baseline in Barnes Akathisia Rating Scale (BARS)","The BARS is a rating scale intended for the assessment of neuroleptic-induced akathisia. The global score ranges from 0 to 5 (0 = no akathisia; 5 = severe akathisia), and higher scores indicate more severe akathisia (worse outcome).",{"measure":45,"description":46,"timeFrame":17},"Change From Baseline in the Modified Simpson Angus Scale (MSAS)","The MSAS consists of a list of 10 symptoms of Parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). Each item will be rated on a 5-point scale, with a score of zero representing absence of symptoms, and a score of 4 representing a severe condition. The MSAS Total Score is the sum of the scores for all 10 items, ranging from 0 to 40. Higher scores indicate more severe movement disorder.",{"allocation":48,"interventionModel":49,"interventionModelDescription":11,"primaryPurpose":50,"observationalModel":11,"timePerspective":11,"maskingInfo":51},"NA","SINGLE_GROUP","TREATMENT",{"masking":52,"maskingDescription":11,"whoMasked":11},"NONE",[54],{"label":55,"type":56,"description":57,"interventionNames":58},"SEP-363856","EXPERIMENTAL","Participants will receive SEP-363856 50 mg or 75 mg tablet, orally, once daily for up to 26 weeks.",[59],"Drug: SEP-363856",[61],{"type":62,"name":55,"description":63,"armGroupLabels":64,"otherNames":65},"DRUG","Oral tablet",[55],[66],"Ulotaront",[68],{"name":69,"role":70,"phone":71,"phoneExt":11,"email":72},"Otsuka Call Center","CONTACT","844-687-8522","ProfessionalServices@otsuka-us.com",{"type":74,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100653514","phase-3-a-trial-of-the-safety-and-tolerability-of-sep-363856-in-adults-with-generalized-anxiety-disorder-100653514",false,"NCT07786454","A Trial of the Safety and Tolerability of SEP-363856 in Adults With Generalized Anxiety Disorder","A Phase 3, Multicenter, Open-Label Extension Trial to Evaluate the Safety and Tolerability of SEP-363856 in the Treatment of Adults With Generalized Anxiety Disorder","Key Inclusion Criteria\n\n1. Male or female participants at least 18 years of age at the time of informed consent\n2. Completed one of the prior GAD Phase 3 studies involving SEP-363856 through Week 8 without discontinuation of trial intervention\n3. Able to continue treatment without interruption, and is considered by investigator to potentially benefit from SEP-363856\n4. Participant is willing and able to comply with study procedures and visit schedule\n5. i) Females of childbearing potential: negative pregnancy test and agreement to use acceptable contraception ii) Males: agreement to follow protocol-defined contraception and reproductive restrictions\n\nKey Exclusion Criteria\n\n1. Diagnosis other than GAD that is the primary focus of treatment\n2. Clinically significant psychiatric or medical condition that may interfere with study participation\n3. Lifetime history of meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for, or was diagnosed during the prior study with, a psychiatric disorder that would compromise accurate assessment of safety and efficacy outcomes\n4. Clinically significant abnormal laboratory values or ECG findings\n5. Significant suicide risk\n6. Substance use\u002Fpositive drug screen\n7. Use of prohibited medications\u002Ftherapies\n8. Known sensitivity to SEP-363856","ALL","18 Years",{"count":85,"type":86},1120,"ESTIMATED","INTERVENTIONAL",[89],"PHASE3","This is a global, Phase 3, multicenter, open-label extension trial designed to evaluate the long-term safety, tolerability and efficacy of SEP-363856 administered at doses of 50 milligrams (mg) or 75 mg per day in adult participants with generalized anxiety disorder (GAD) over a treatment period of 26 weeks.",[92],"Generalized Anxiety Disorder",[92,94,95],"GAD","Anxiety","NOT_YET_RECRUITING","2026-08-20",{"date":99,"type":100},"2026-08-26","ACTUAL",{"date":102,"type":86},"2026-10-06",{"date":104,"type":86},"2029-06-02",{"name":5,"class":6}]