An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an extension of a previous study (ALK9072-003EXT). The purpose of this study is to continue to evaluate the long-term safety and durability of effect of ALKS 9072 in subjects with stable schizophrenia, and to allow subjects who are doing well on ALKS 9072 to continue treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alkermes, Inc.

Criteria

Inclusion Criteria:

• Completed the treatment period of Study ALK9072-003EXT

• Continues to require chronic treatment with an antipsychotic medication

• Continues to reside in a stable living situation

• Continues to have an identified reliable informant

Exclusion Criteria:

• Abnormal clinical laboratory value, vital sign, or electrocardiogram (ECG) finding during participation in Study ALK9072-003EXT that was clinically relevant and related to study drug

• Missed more than 1 scheduled study visit during participation in the preceding Study ALK9072-003EXT

• Has a significant or unstable medical condition that would preclude safe completion of the current study

• Subject is pregnant or breastfeeding

• Subject expects to be incarcerated, or has pending legal action which may impact compliance with study participation or procedures