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Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831

NCT03201757 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 523

Last updated 2024-09-26

Study results available
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Summary

This study will evaluate the long-term safety, tolerability, and durability of treatment effect of ALKS 3831 in subjects with schizophrenia, schizophreniform disorder, or bipolar I disorder

Conditions

Interventions

DRUG

ALKS 3831

Olanzapine + samidorphan, daily oral dosing

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
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-15
Primary Completion
2023-09-06
Completion
2023-09-06
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Bulgaria
  • Ireland
  • Israel
  • Italy
  • Poland
  • Puerto Rico
  • Russia
  • Serbia
  • South Korea
  • Ukraine
  • United Kingdom

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 NCT03201757 on ClinicalTrials.gov