An Extension Study of Safety and Tolerability of SEP-363856 in Adult Subjects With Schizophrenia

NCT02970929 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: SEP361-2022016-001556-21
• Study Type: interventional
• Target: 157
• Locations: 5 countries
• Sites: 30

Brief Summary

An extension study of safety and tolerability of SEP-363856 in adult subjects with schizophrenia

Conditions

Schizophrenia

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• The Incidence of Overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Discontinuation

  Number of Participants with overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to discontinuation

  From first dose of study drug to last study visit (27 weeks)

Secondary Outcomes (9)

• Frequency of Suicidal Ideation (SI) and Suicidal Behavior (SB) Using the Columbia - Suicide Severity Rating Scale (C-SSRS)

  Overall post Open-label Baseline treatment period (26 weeks)

• Severity of Suicidal Ideation (SI) and Suicidal Behavior (SB) Using the Columbia - Suicide Severity Rating Scale (C-SSRS)

  Overall post Open-label Baseline treatment period (26 weeks)

• Time to Relapse During the 26-week Open-label Treatment Period for Subjects Who Demonstrated a Clinical Response to 4 Weeks of Treatment With SEP-363856

  From the time of clinical response to relapse or censor (one day after the last study drug dose)

• Rate of Relapse During the 26-week Open-label Treatment Period for Subjects Who Demonstrated a Clinical Response to 4 Weeks of Treatment With SEP-363856

  From the time of clinical response to relapse or censor (one day after the last study drug dose)

• Changes From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Positive and Negative Syndrome Scale (PANSS) Total Score and Subscale Scores (Positive, Negative, and General Psychopathology)

  Double-blind Baseline (DB BLN), Open-label Baseline (OL BLN), Week 26 (Wk 26)

Study Arms (1)

SEP-363856

EXPERIMENTAL

SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily

Drug: SEP-363856

Interventions

SEP-363856 DRUG

One SEP-363856 capsule (25 mg, 50 mg or 75 mg (flex)) daily for 26 weeks

SEP-363856

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject must give written informed consent and privacy authorization prior to participation in the study and able to comply with the protocol, in the opinion of the investigator.
• Subject has completed Study SEP361 201 through Week 4
• Subject has not taken any medication other than the study drug for the purpose of controlling schizophrenia symptoms during Study SEP361 201.
• Female subject must have a negative urine pregnancy test at Visit 7 of Study SEP361 201; females who are post-menopausal (defined as at least 12 months of spontaneous amenorrhea) and those who have undergone hysterectomy or bilateral oophorectomy will be exempted from the pregnancy test.
• Male subjects with female partner(s) of childbearing potential must agree to avoid fathering a child and use acceptable methods of birth control from screening until at least 30 days after the last study drug administration

You may not qualify if:

• Subject answers "yes" to "suicidal ideation" Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at Visit 7 of Study SEP361 201. Subjects who answer "yes" to this question must be referred to the Investigator for follow up evaluation.
• Subject has a clinically significant abnormality including physical examination, vital signs, ECG, or laboratory test at Visit 7 of Study SEP361 201 that the investigator in consultation with the medical monitor considers to be inappropriate to allow participation in the study.
• Subject has a positive urine drug screen (UDS) or breath alcohol test at Visit 7 of Study SEP361 201.
• Subject is pregnant or lactating.
• Subject is at high risk of non-compliance in the Investigator's opinion.
• Subject is in the opinion of the Investigator, unsuitable in any other way to participate in this study.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (30)

Woodland International research Group

Little Rock, Arkansas, 72211, United States

Location

CNRI-Los Angeles, LLC

Pico Rivera, California, 90660, United States

Location

UCSD Medical Center UCSD Department of Psychiatry

San Diego, California, 92103-8229, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

Kashinath Yadalam

Lake Charles, Louisiana, 70629, United States

Location

Pillar Clinical Research, LLC

Dallas, Texas, 75243, United States

Location

Bugát Pál Kórház-Rendelőintézet, Rehabilitációs Elmegyógyászati Osztály

Gyöngyös, Dózsa György, út 20-22, Hungary

Location

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza, Pszichiatriai Osztaly

Gyula, 5700, Hungary

Location

Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila"

Bucharest, 010825, Romania

Location

Centrul de Evaluarea si Tratament al Toxicodependentelor pentru Tineri "Sf. Stelian", Sectia Psihiatrie

Bucharest, 060222, Romania

Location

spitalul Clinic de Neuropsihiatrie Craiova ,Clinica II Psihiatrie

Craiova, 200473, Romania

Location

Institutul de Psihiatrie Socola Iasi, Sectia Psihiatrie III Acuti

Iași, 700282, Romania

Location

St-Petersburg SHI Psychiatrical hospital #1 n.a. Kaschenko

Gatchina, 188357, Russia

Location

City Psychiatric Hospital of St. Nikolay Chudotvorets

Saint Petersburg, 190121, Russia

Location

FB=SBI"Saint Petersburg Scientific and Research Psychoneurological Institute n.a. V.M. Bekhterev"

Saint Petersburg, 192019, Russia

Location

SPHI "City Mental Hospital #3 n.a. I.I.Skvortsov-Stepanov"

Saint Petersburg, 197341, Russia

Location

SPb SBIH "City Psychoneurological Dispensary #7 (with inpatient facilities)"

Saint Petersburg, 198020, Russia

Location

SHI Regional Clinical Psychiatry Hospital of St. Sofia

Saratov, 410060, Russia

Location

FSBEI HE "Smolensk State Medical University" of the MoH of the RF

Smolensk, 214019, Russia

Location

Sverdlov Regional Psychiatric Clinical Hospital

Yekaterinburg, 620030, Russia

Location

Regional Psychoneurological Hospital #3, Dept of Crisis Cond & Primary Psych Episode #1

Ivano-Frankivsk, 76014, Ukraine

Location

CHI Kharkiv RCPH#3 Center of Emerg PsychSI Inst of Neur, Psych & Narc of NAMSU, Unit of Emergency Psychiatry and Narcology

Kharkiv, 61068, Ukraine

Location

CHI Kharkiv Regional Clinical Psychiatric Hospital #3, Psychiatric Department of Primary Psychotic Episod

Kharkiv, 61068, Ukraine

Location

CI Kherson Regional Psychiatric Hospital of Kherson RC

Kherson, 73488, Ukraine

Location

TMA Psychiatry in Kyiv Center of NT & Rehabilitation of Psychotic Conditions

Kyiv, 04080, Ukraine

Location

CI Odesa Regional Medical Center of Mental Health

Odesa, 65006, Ukraine

Location

CI Cherkasy Regional Psychiatric Hospital of ChRC, Femail Dept #11, Male Dept #12

Smila, 20708, Ukraine

Location

Ternopil RCCPH Depts of Psychiatry #2 (m) & Psychiatry #6 Ternopil I.ya. Gorbachevskyi SMU

Ternopil, 46020, Ukraine

Location

Transcarpathian Regional Narcological Dispensary

Uzhhorod, 88000, Ukraine

Location

CI O.I. Yuschenko VRPsH Depts #7 & #10 M.I. Pyrogov VNMU

Vinnytsia, 21005, Ukraine

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

SEP-363856

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: CNS Medical Director
• Organization: Sunovion Pharmaceuticals Inc.

clinicaltrialdisclosure@sunovion.com

1 866-503-6351

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: November 22, 2016
• Study Start: January 31, 2017
• Primary Completion: January 29, 2019
• Study Completion: January 29, 2019
• Last Updated: July 5, 2024
• Results First Posted: February 9, 2022

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
• Access Criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/

Locations

UA (10); RU (8); US (6); HU (2); RO (4)