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A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia

NCT02873208 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2021-07-21

Study results available
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Summary

The primary objective of this study is to evaluate the long-term safety and tolerability of ALKS 3831 in subjects with schizophrenia.

Conditions

Interventions

DRUG

ALKS 3831

Coated bilayer tablet containing 10 mg, 15 mg or 20 mg olanzapine and 10 mg samidorphan

Sponsors & Collaborators

  • Alkermes, Inc.

    lead INDUSTRY

Principal Investigators

  • Alkermes Medical Director · Alkermes, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-08-07
Primary Completion
2019-10-17
Completion
2019-10-17

Countries

  • United States
  • Puerto Rico

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 NCT02873208 on ClinicalTrials.gov