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

Schizophrenia Clinical Trial

Official title:

A 26-Week Open-label Safety and Tolerability Extension Study of SEP-363856 in Adult Subjects With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02970929
• Other study ID #: SEP361-202
• Secondary ID: 2016-001556-21
• Status: Completed
• Phase: Phase 2
• Start date: January 31, 2017
• Est. completion date: January 29, 2019

Study information

• Verified date: February 2022
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This is a 26 week, multiregional, open-label extension study designed to evaluate the long-term safety and tolerability of SEP-363856 for the treatment of subjects with schizophrenia who have completed the 4 week double-blind treatment phase of Study SEP361-201 (NCT02969382) Subjects received open-label SEP-363856 50 mg/day from Day 1 through Day 3, and then received flexible dosing of SEP-363856 (25, 50, or 75 mg/day) for the rest of the trial. No statistical hypothesis tests will be performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: January 29, 2019
• Est. primary completion date: January 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
Hungary	Bugát Pál Kórház-Rendelointézet, Rehabilitációs Elmegyógyászati Osztály	Gyongyos	Dózsa György
Hungary	Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza, Pszichiatriai Osztaly	Gyula
Romania	Centrul de Evaluarea si Tratament al Toxicodependentelor pentru Tineri "Sf. Stelian", Sectia Psihiatrie	Bucuresti
Romania	Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila"	Bucuresti
Romania	spitalul Clinic de Neuropsihiatrie Craiova ,Clinica II Psihiatrie	Craiova
Romania	Institutul de Psihiatrie Socola Iasi, Sectia Psihiatrie III Acuti	Iasi
Russian Federation	Sverdlov Regional Psychiatric Clinical Hospital	Ekaterinburg
Russian Federation	St-Petersburg SHI Psychiatrical hospital #1 n.a. Kaschenko	Gatchina
Russian Federation	SPHI "City Mental Hospital #3 n.a. I.I.Skvortsov-Stepanov"	Saint-Petersburg
Russian Federation	SHI Regional Clinical Psychiatry Hospital of St. Sofia	Saratov
Russian Federation	FSBEI HE "Smolensk State Medical University" of the MoH of the RF	Smolensk
Russian Federation	City Psychiatric Hospital of St. Nikolay Chudotvorets	St. Petersburg
Russian Federation	FB=SBI"Saint Petersburg Scientific and Research Psychoneurological Institute n.a. V.M. Bekhterev"	St. Petersburg
Russian Federation	SPb SBIH "City Psychoneurological Dispensary #7 (with inpatient facilities)"	St. Petersburg
Ukraine	Regional Psychoneurological Hospital #3, Dept of Crisis Cond & Primary Psych Episode #1	Ivano Frankivsk
Ukraine	CHI Kharkiv RCPH#3 Center of Emerg PsychSI Inst of Neur, Psych & Narc of NAMSU, Unit of Emergency Psychiatry and Narcology	Kharkiv
Ukraine	CHI Kharkiv Regional Clinical Psychiatric Hospital #3, Psychiatric Department of Primary Psychotic Episod	Kharkiv
Ukraine	CI Kherson Regional Psychiatric Hospital of Kherson RC	Kherson, Vil Stepanivka
Ukraine	TMA Psychiatry in Kyiv Center of NT & Rehabilitation of Psychotic Conditions	Kyiv
Ukraine	CI Odesa Regional Medical Center of Mental Health	Odesa
Ukraine	CI Cherkasy Regional Psychiatric Hospital of ChRC, Femail Dept #11, Male Dept #12	Smila
Ukraine	Ternopil RCCPH Depts of Psychiatry #2 (m) & Psychiatry #6 Ternopil I.ya. Gorbachevskyi SMU	Ternopil
Ukraine	Transcarpathian Regional Narcological Dispensary	Uzhgorod
Ukraine	CI O.I. Yuschenko VRPsH Depts #7 & #10 M.I. Pyrogov VNMU	Vinnytsia
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Pillar Clinical Research, LLC	Dallas	Texas
United States	Kashinath Yadalam	Lake Charles	Louisiana
United States	Woodland International research Group	Little Rock	Arkansas
United States	CNRI-Los Angeles, LLC	Pico Rivera	California
United States	UCSD Medical Center UCSD Department of Psychiatry	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Countries where clinical trial is conducted

United States,  Hungary,  Romania,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Frequency of Suicidal Ideation (SI) and Suicidal Behavior (SB) Using the Columbia - Suicide Severity Rating Scale (C-SSRS)	Number of participants with suicidal ideation (SI) and suicidal behavior (SB) using the Columbia - Suicide Severity Rating Scale (C-SSRS). The C-SSRS is a tool designed to systematically assess and track suicidal behavior and suicidal ideation for life time, one month prior to the screening visit for suicidal ideation and 6 months prior to the screening visit for suicidal behavior, and throughout the study. The strength of this suicide classification system is in its ability to comprehensively identify suicidal events while limiting the over-identification of suicidal behavior.	Overall post Open-label Baseline treatment period (26 weeks)
Secondary	Severity of Suicidal Ideation (SI) and Suicidal Behavior (SB) Using the Columbia - Suicide Severity Rating Scale (C-SSRS)	The C-SSRS is a tool designed to systematically assess and track suicidal behavior and suicidal ideation for life time, one month prior to the screening visit for suicidal ideation and 6 months prior to the screening visit for suicidal behavior, and throughout the study. The strength of this suicide classification system is in its ability to comprehensively identify suicidal events while limiting the over-identification of suicidal behavior.	Overall post Open-label Baseline treatment period (26 weeks)
Secondary	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	Relapse is defined as the earliest occurrence of any of the following: - An increase in PANSS total score by = 30% from the PANSS total score at clinical response and a CGI-S score = 3; - Re-hospitalization for worsening of psychosis; - Emergence of suicidality, homicidality, and/or risk of harm to self or others.	From the time of clinical response to relapse or censor (one day after the last study drug dose)
Secondary	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	Relapse is defined as the earliest occurrence of any of the following: - An increase in PANSS total score by = 30% from the PANSS total score at clinical response and a CGI-S score = 3; - Re-hospitalization for worsening of psychosis; - Emergence of suicidality, homicidality, and/or risk of harm to self or others.	From the time of clinical response to relapse or censor (one day after the last study drug dose)
Secondary	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)	PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210.	Double-blind Baseline (DB BLN), Open-label Baseline (OL BLN), Week 26 (Wk 26)
Secondary	Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Clinical Global Impression - Severity (CGI-S) Score	The CGI-S is a single-item clinician-rated assessment of the subject's current illness state on a 7-point scale (score range: 1-7), where a higher score is associated with greater illness severity.	Double-blind (DB) Baseline, Open-label (OL) Baseline, Week 26
Secondary	Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Brief Negative Symptom Scale (BNSS) Total Score	The BNSS is a rating scale to measure the current level of severity of negative symptoms in schizophrenia and schizoaffective disorder. The measure is comprised of 13 individual items organized in 6 subscales. The 13 individual items provide a composite total score (ranging from 0 to 78). Each of the items are scored on a Likert-type 7-point scale from 0 - 6, where values of 0 indicates symptom is absent and a value of 6 means the symptom is a severe form.	Double-blind (DB) Baseline, Open-label (OL) Baseline, Week 26
Secondary	Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	The MADRS is a clinician-rated assessment of the subject's level of depression. The measure contains 10 items that measure apparent and reported sadness, inner tension, reduced sleep and appetite, difficulty concentrating, lassitude, inability to feel, and pessimistic and suicidal thoughts. Each item is scored in a range of 0 to 6 points, with higher scores indicating increased depressive symptoms.; Total score will be equal to the sum of the 10 items (range between 0 and 60).	Double-blind (DB) Baseline, Open-label (OL) Baseline, Week 26
Secondary	Proportion of Subjects Who Achieved a Response, Defined as a 20% or Greater Improvement in Positive and Negative Syndrome Scale (PANSS) Total Score From Double-blind Baseline of Study SEP361-201	PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210.	Week 26