A Clinical Study That Will Evalute How Well SEP-363856 Works and How Safe it is in People With Schizophrenia That Switch to SEP-363856 From Their Current Antisychotic Medication

Sponsor
Sunovion (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05628103
Collaborator
(none)
120
15
1
19.2
8
0.4

Study Details

Study Description

Brief Summary

A clinical study that will evalute how well SEP-363856 works and how safe it is in people with schizophrenia that switch to SEP-363856 from their current antisychotic medication. This study will accept both male and female participants, ages of 18 years to 65 years, with schizophrenia. The study will take place in approxmiately 24 study sites in North America. Particpants should expect to be in the study for up to 12 weeks.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

This is an 8-week, outpatient, multicenter, open-label, single-group, flexible-dose study designed to evaluate the safety and tolerability, as well as effectiveness of switching clinically stable adult subjects with schizophrenia from a typical or atypical antipsychotic to SEP-363856. This study is projected to enroll approximately 120 subjects into a single treatment group (SEP-363856).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An 8-Week, Open-Label Study Evaluating the Effectiveness, Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia Switched From Typical or Atypical Antipsychotic Agents
Actual Study Start Date :
Dec 19, 2022
Anticipated Primary Completion Date :
Jul 24, 2024
Anticipated Study Completion Date :
Jul 24, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: SEP-363856

SEP-363856 flexibly dosed

Drug: SEP-363856
SEP-363856 flexibly dosed

Outcome Measures

Primary Outcome Measures

  1. Percentage of subjects who discontinue for clinical reasons (ie, discontinued due to an adverse event [AE] or lack of efficacy) [Up to Week 12]

Secondary Outcome Measures

  1. Percentage of subjects who discontinue for any reason (ie, all causes for discontinuation) [Up to Week 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

Inclusion Criteria: This list is not all inclusive

  • Male or female subject between 18 to 65 years of age.

  • Subject meets DSM-5 criteria for a diagnosis of schizophrenia.

  • Subject is judged to be clinically stable (ie, no evidence of an acute exacerbation of schizophrenia) by the Investigator for at least 8 weeks prior to Baseline.

  • Subject must be judged by the Investigator to be an appropriate candidate for switching current antipsychotic medication due to safety or tolerability concerns and/or insufficient efficacy.

  • Subject is taking an oral antipsychotic and the antipsychotic regimen has been stable for at least 6 weeks prior to Screening.

Exclusion Criteria:This list is not all inclusive

  • Subject has a current DSM-5 diagnosis or presence of symptoms consistent with a major psychiatric disorder, other than schizophrenia, that is the primary focus of treatment.

  • Subject is at significant risk of harming self or others based on investigator's judgment.

  • Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study.

  • Female subject who is pregnant or lactating.

  • Subject tests positive for drugs of abuse at Screening.

Contacts and Locations

Locations

Site City State Country Postal Code
1 ProScience Research Group Culver City California United States 90230
2 Collaborative Neuroscience Research, LLC Garden Grove California United States 92845
3 Synergy San Diego Lemon Grove California United States 91945
4 Clinical Innovations, Inc Riverside California United States 92506
5 California Neuropsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC) San Diego California United States 92102
6 CMB Clinical Trials Santee California United States 92071
7 Cenexel CNS Research Torrance California United States 90502
8 Larkin Behavioral Health Services Hollywood Florida United States 33021
9 Advanced Discovery Research LLC Atlanta Georgia United States 30318
10 Atlanta Center for Medical Research Atlanta Georgia United States 30331
11 Uptown Research Chicago Illinois United States 60640
12 CBH Health Gaithersburg Maryland United States 20877
13 Hassman Research Institute Berlin New Jersey United States 08009
14 Clinical Trials of America, LLC Hickory North Carolina United States 28601
15 Charak Clinical Research Center Garfield Heights Ohio United States 44125

Sponsors and Collaborators

  • Sunovion

Investigators

  • Study Chair: CNS Medical Director, Sunovion

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sunovion
ClinicalTrials.gov Identifier:
NCT05628103
Other Study ID Numbers:
  • SEP361-308
First Posted:
Nov 28, 2022
Last Update Posted:
Jan 27, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sunovion
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 27, 2023