MedTrace Logo

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

NCT02970929 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2024-07-05

Study results available
· View outcomes & findings →

Summary

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

Conditions

Interventions

DRUG

SEP-363856

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

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2019-01-29
Completion
2019-01-29
FDA Drug
Yes

Countries

  • United States
  • Hungary
  • Romania
  • Russia
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02970929 on ClinicalTrials.gov