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A Clinical Study to Evaluate the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia

NCT04109950 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 463

Last updated 2024-12-16

No results posted yet for this study

Summary

This is a clinical trial to determine the long-term safety and tolerability of an investigational drug in people with schizophrenia. Participants in the study will receive the drug being studied. This study is accepting male and female participants between 13 and 65 years old who have been diagnosed with schizophrenia and have completed Study SEP361-301 (NCT04072354) or Study SEP361-302 (NCT04092686). This study will be conducted in approximately 80 study centers worldwide. The treatment duration for this study is one (1) year.

Conditions

  • Schizophrenia

Interventions

DRUG

SEP-363856

SEP-363856 25mg, 50mg, 75mg, 100mg tablet flexibly dosed once daily

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-20
Primary Completion
2023-11-09
Completion
2023-11-09
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Colombia
  • Croatia
  • Latvia
  • Russia
  • Serbia
  • Ukraine

Study Locations

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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 NCT04109950 on ClinicalTrials.gov