A Phase 3, 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

NCT02873208

ALK3831-A304

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: 266 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Agrees to use an acceptable method of contraception for the duration of the study
• Subject has completed the 24-week treatment period in the antecedent study, ALK3831-A303, within 7 days
• Additional criteria may apply

Exclusion criteria

• Subject is currently taking medications that are contraindicated with olanzapine use or exhibit drug-interaction potential with olanzapine
• 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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266 participants in 1 patient group

ALKS 3831

Experimental group

Description:

Oral tablet, daily dosing

Treatment:

Drug: ALKS 3831