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

Status:	Completed
Conditions:	Schizophrenia
Therapuetic Areas:	Psychiatry / Psychology
Healthy:	No
Age Range:	18 - 70
Updated:	7/15/2016
Start Date:	July 2013
End Date:	June 2016

A Phase 3, Multicenter Extension of Study ALK9072-003EXT to Assess the Long-term Safety and Durability of Effect of ALKS 9072 in Subjects With Stable Schizophrenia

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.

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

We found this trial at

sites

Alkermes Investigational Site

Leesburg, Florida 34748

1106

from

Leesburg, FL