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

Alkermes

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: ALKS 3831

Study type: Interventional

Funder types: Industry

Identifiers

NCT02669758

ALK3831-A306

Details and patient eligibility

About

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

Enrollment: 281 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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281 participants in 1 patient group

ALKS 3831

Experimental group

Description:

Olanzapine + samidorphan; administered as a coated bilayer tablet.

Treatment:

Drug: ALKS 3831