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A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With 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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and week 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 6
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
48,470 Total Patients Enrolled
45 Trials studying Schizophrenia
8,867 Patients Enrolled for Schizophrenia
Sumitomo Pharma America, Inc.Lead Sponsor
241 Previous Clinical Trials
50,982 Total Patients Enrolled
45 Trials studying Schizophrenia
8,867 Patients Enrolled for Schizophrenia
Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
265 Previous Clinical Trials
168,634 Total Patients Enrolled
81 Trials studying Schizophrenia
21,431 Patients Enrolled for Schizophrenia
CNS Medical DirectorStudy ChairSumitomo Pharma America, Inc.
32 Previous Clinical Trials
5,437 Total Patients Enrolled
14 Trials studying Schizophrenia
2,289 Patients Enrolled for Schizophrenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are experiencing significant decline in one or more areas of your daily functioning.You have severe mental health symptoms that have lasted for up to 2 months before agreeing to participate in the study.
Research Study Groups:
This trial has the following groups:- Group 1: SEP-363856 75mg
- Group 2: Placebo
- Group 3: SEP-363856 100mg
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.