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Investigational Drug 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 53 weeks
Awards & highlights

Study Summary

This trial is to study the long-term safety of an investigational drug for people with schizophrenia. The study is open to males and females between 13-65 years old who have completed Study SEP361-301 or SEP361-302. The study will last one year and will be conducted at 80 study centers worldwide.

Who is the study for?
This trial is for males and females aged 13-65 with schizophrenia who've completed prior studies SEP361-301 or SEP361-302. Participants must not be pregnant, agree to use effective birth control, and have used only allowed medications for schizophrenia during previous studies.Check my eligibility
What is being tested?
The study tests the long-term safety of a new drug called SEP-363856 over one year. It's open to those previously in related trials and will take place across roughly 80 global centers.See study design
What are the potential side effects?
While specific side effects are not listed here, they typically include any negative reactions participants experience from the investigational drug throughout the trial duration.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~53 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 53 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The incidence of overall Adverse Events (AEs), Serious Adverse Events (AEs), and Adverse Events (AEs) leading to discontinuation

Side effects data

From 2020 Phase 2 trial • 39 Patients • NCT02969369
22%
Hallucination
19%
Fall
19%
Dizziness
16%
Confusional state
13%
Nausea
9%
Somnolence
9%
Anxiety
9%
Delusion
9%
Insomnia
9%
Hypotension
6%
Fatigue
6%
Urinary tract infection
6%
Aggression
6%
Agitation
6%
Pain
6%
Hypertension
3%
Corneal abrasion
3%
Asthenia
3%
Balance disorder
3%
Hip fracture
3%
Mental disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
SEP-363856

Trial Design

1Treatment groups
Experimental Treatment
Group I: SEP-363856Experimental Treatment1 Intervention
SEP-363856 25mg, 50mg, 75mg, 100mg flexibly dosed once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SEP-363856
2016
Completed Phase 2
~850

Find a Location

Who is running the clinical trial?

SunovionLead Sponsor
191 Previous Clinical Trials
50,263 Total Patients Enrolled
45 Trials studying Schizophrenia
8,887 Patients Enrolled for Schizophrenia
Sumitomo Pharma America, Inc.Lead Sponsor
236 Previous Clinical Trials
52,268 Total Patients Enrolled
45 Trials studying Schizophrenia
8,887 Patients Enrolled for Schizophrenia
CNS Medical DirectorStudy ChairSumitomo Pharma America, Inc.
33 Previous Clinical Trials
6,330 Total Patients Enrolled
14 Trials studying Schizophrenia
2,309 Patients Enrolled for Schizophrenia

Media Library

Schizophrenia Research Study Groups: SEP-363856
Schizophrenia Clinical Trial 2023: SEP-363856 Highlights & Side Effects. Trial Name: NCT04109950 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

If an elderly patient is not yet 70, can they still qualify for this treatment program?

"This particular clinical trial is only testing subjects that are between the ages of 13 and 65. There are a total of 49 studies testing subjects below the age of 18 and 179 studies testing subjects above the age of 65."

Answered by AI

Could you tell me how many different hospitals or medical centers are participating in this research?

"19 different centres are enrolling patients for this trial, which include South Florida Research Phase I-IV, Inc. in Miami Springs, Alliance for Research in Long Beach, and iResearch Atlanta, LLC in Decatur."

Answered by AI

How do I know if I can join this research project?

"This clinical trial is looking for 555 participants between the ages of 13 and 65 who have been diagnosed with schizophrenia. In addition to meeting this age and diagnosis criteria, potential subjects must also:-Have given written informed consent and privacy authorization prior to participating in the study (or have a parent/legal guardian do so for adolescents); adolescents must also provide informed assent.-Have a negative urine pregnancy test at the End of Treatment (EOT) Visit of Study SEP361-301 or Study SEP361-302.-Have completed the Treatment Period of Study SEP361-301 or Study SEP"

Answered by AI

What makes this research project unique compared to others like it?

"SEP-363856 has undergone 6 clinical trials in 9 countries and 64 cities since 2019. The first Phase 1 trial, sponsored by Sunovion, included 22 patients and completed in 2019. Since then, 11 more trials have concluded."

Answered by AI

What are the findings of earlier SEP-363856 medical studies?

"There are currently 6 ongoing clinical trials researching SEP-363856, with 5 of them in Phase 3. The majority of the research is taking place in Pazardzhik, Mississippi; however, there are a total of 272 research sites for SEP-363856."

Answered by AI

What is the maximum patient sample size for this particular research project?

"In order to run this trial, the sponsor needs to recruit 555 patients that meet the required criteria. The trial will be conducted by Sunovion at multiple sites, such as South Florida Research Phase I-IV, Inc. in Miami Springs, Florida and Alliance for Research in Long Beach, Georgia."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What state do they live in?
New Jersey
California
Texas
What site did they apply to?
Fort Lauderdale Behavioral Health Center
Hassman Research Institute
Schuster Medical Research Institute
Other
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

I’ve trying 3 other drugs hopefully this program works. I'm in a seemingly endless downward spiral with less and less hope for my existence.
PatientReceived no prior treatments
I've been in the hospital 3 times when I was diagnosed with schizophrenia. I feel like research should be the best option to do since i've had this issue for a while now.
PatientReceived no prior treatments
I’m currently on some other AP’s but really find no benefit from them for addressing negative symptoms. I’m also interested in this drug for targeting the underlying anhedonia and depression that led to the development of schizophrenia for me thank you!
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Most responsive sites:
  1. Schuster Medical Research Institute: < 48 hours
Recent research and studies
clinicaltrials.govStudy
A Clinical Study to Evaluate the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia
2019. "A Clinical Study to Evaluate the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04109950.
~82 spots leftby Apr 2025
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