A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
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|ClinicalTrials.gov Identifier: NCT04092686|
Recruitment Status : Recruiting
First Posted : September 17, 2019
Last Update Posted : October 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: SEP-363856 75mg Drug: SEP-363856 100mg Drug: Placebo||Phase 3|
This is a multicenter, randomized, double-blind, parallel-group, fixed-dosed study evaluating the efficacy and safety of two doses of SEP-363856 (75 and 100 mg/day) versus placebo over a 6-week Treatment Period in acutely psychotic subjects with schizophrenia. This study is projected to randomize approximately 462 subjects to 3 treatment groups (SEP-363856 75 mg/day, SEP-363856 100 mg/day, or placebo) in a 1:1:1 ratio. Treatment assignment will be stratified by country. Study drug will be taken once a day and may be taken with or without food.
This study is designed to test the hypotheses that treatment with SEP-363856 in adult subjects with schizophrenia will result in significantly greater reduction (i.e. improvement) in PANSS total score and CGI-S score at Week 6 from Baseline when compared to placebo. The overall Type I error is controlled for two hierarchical families of hypotheses. The first family includes hypotheses about the testing of change from Baseline in PANSS total score at Week 6 between each of the SEP-363856 dose levels vs. placebo. The second family of hypotheses are about the testing of change from Baseline in CGI-S score at Week 6 between each of the SEP-363856 dose levels vs. placebo.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||462 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A randomized, double-blind, parallel-group, placebo-controlled, fixed-dose, multicenter study|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Subjects With Schizophrenia|
|Actual Study Start Date :||September 30, 2019|
|Estimated Primary Completion Date :||October 26, 2021|
|Estimated Study Completion Date :||October 26, 2021|
Experimental: SEP-363856 75mg
SEP-363856 75mg dosed once daily
Drug: SEP-363856 75mg
SEP-363856 75mg tablet dosed once daily
Experimental: SEP-363856 100mg
SEP-363856 100mg dosed once daily
Drug: SEP-363856 100mg
SEP-363856 100mg tablet dosed once daily
Placebo Comparator: Placebo
Placebo dosed once daily
Placebo tablet dosed once daily
- Change from Baseline in Positive and negative syndrome scale (PANSS) total score at Endpoint (Week 6) [ Time Frame: Baseline and Week 6 ]PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210.
- Change from Baseline in Clinical Global Impressions - Severity (CGI-S) score at Endpoint (Week 6) [ Time Frame: Baseline and Week 6 ]The CGI-S is a single-item clinician-rated assessment of the subject's current illness state on a 7-point scale (score range: 1-7), where a higher score is associated with greater illness severity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04092686
|Contact: CNS Medical Director||1-866-503-6351||ClinicalTrialDisclosure@sunovion.com|
|Study Chair:||CNS Medical Director||Sunovion|