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Completed

NCT Number: NCT02669758

A Long-Term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia

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

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alkermes Investigational Site, Burgas, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject has completed the 4-week treatment period (all visits up to and including end of treatment visit) in the antecedent study ALK3831-A305 within 7 days.
  • Agrees to use an acceptable method of contraception for the duration of the study.
  • Additional criteria may apply.

Exclusion criteria

  • Subject is currently taking medications that are contraindicated with olanzapine use.
  • Subject has a positive test for drugs of abuse at study entry.
  • Subject is pregnant, planning to become pregnant, or breastfeeding during the study.
  • Additional criteria may apply.

Treatment and study plan

ALKS 3831

Drug

Tablets were administered for daily dosing

Primary outcomes

  1. Number of Participants With Adverse Events (AEs)

    Time frame: Up to 52 weeks

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study title

A Phase 3, Multicenter Study to Assess the Long Term Safety and Tolerability of ALKS 3831 in Subjects With Schizophrenia

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 1, 2016
Registry last updated
Jul 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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