← Back to Search

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 6
Awards & highlights
Pivotal Trial

Summary

This trial is testing a new drug called SEP-363856 to see if it helps adults with severe schizophrenia symptoms. The drug aims to make people feel better by reducing their symptoms.

Eligible Conditions
  • Schizophrenia

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

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 100mgExperimental Treatment1 Intervention
SEP-363856 100mg 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 100mg
2019
Completed Phase 3
~470
SEP-363856 75mg
2019
Completed Phase 3
~930

Find a Location

Who is running the clinical trial?

SunovionLead Sponsor
189 Previous Clinical Trials
48,909 Total Patients Enrolled
45 Trials studying Schizophrenia
8,867 Patients Enrolled for Schizophrenia
Sumitomo Pharma America, Inc.Lead Sponsor
241 Previous Clinical Trials
51,421 Total Patients Enrolled
45 Trials studying Schizophrenia
8,867 Patients Enrolled for Schizophrenia
Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
265 Previous Clinical Trials
170,060 Total Patients Enrolled
81 Trials studying Schizophrenia
21,431 Patients Enrolled for Schizophrenia

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04092686 — Phase 3
Schizophrenia Research Study Groups: SEP-363856 75mg, Placebo, SEP-363856 100mg
Schizophrenia Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04092686 — Phase 3
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04092686 — Phase 3
~76 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top