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SEP-363856 75mg for Schizophrenia

Phase 3
Waitlist Available
Research Sponsored by Sunovion
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 6
Awards & highlights

Study Summary

This trial is testing a new drug for people with schizophrenia who are in a psychotic state. The drug will be given to some people, and others will receive a placebo. The study will last up to 9 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Positive and negative syndrome scale (PANSS) total score at Endpoint (Week 6)
Secondary outcome measures
Change from Baseline in Clinical Global Impressions - Severity (CGI-S) score at Endpoint (Week 6)

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: SEP-363856 75mgExperimental Treatment1 Intervention
SEP-363856 75mg dosed once daily
Group II: SEP-363856 50mgExperimental Treatment1 Intervention
SEP-363856 50mg dosed once daily
Group III: PlaceboPlacebo Group1 Intervention
Placebo dosed once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SEP-363856 50mg
2019
Completed Phase 3
~470
SEP-363856 75mg
2019
Completed Phase 3
~930

Find a Location

Who is running the clinical trial?

SunovionLead Sponsor
191 Previous Clinical Trials
50,252 Total Patients Enrolled
45 Trials studying Schizophrenia
8,876 Patients Enrolled for Schizophrenia
Sumitomo Pharma America, Inc.Lead Sponsor
237 Previous Clinical Trials
52,250 Total Patients Enrolled
45 Trials studying Schizophrenia
8,876 Patients Enrolled for Schizophrenia
CNS Medical DirectorStudy ChairSunovion Pharmaceuticals In.
33 Previous Clinical Trials
6,319 Total Patients Enrolled
14 Trials studying Schizophrenia
2,298 Patients Enrolled for Schizophrenia
~82 spots leftby Jun 2025
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