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

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Drug: ALKS 3831

• Registration Number: NCT02669758
• Lead Sponsor: Alkermes, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-20
• Study First Submitted: 2016-01-28
• Study First Submitted QC: 2016-01-28
• Study First Posted: 2016-02-01
• Primary Completion: 2018-06-29
• Study Completion: 2018-06-29
• Results First Submitted: 2019-06-18
• Results First Submitted QC: 2019-06-18
• Status Verified: 2019-07
• Results First Posted: 2019-07-09
• Last Update Submitted: 2019-07-15
• Last Update Posted: 2019-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 281

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ALKS 3831	ALKS 3831	Olanzapine + samidorphan; administered as a coated bilayer tablet.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs)	Up to 52 weeks

Trial Locations

Locations (1)

Alkermes Investigational Site; 🇺🇦 Vinnytsia, Ukraine