Overview

A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)

Status:
Completed
Trial end date:
2015-04-01
Target enrollment:
0
Participant gender:
All
Summary
This study will evaluate the safety and durability of effect of ALKS 9072 (also known as ALKS 9070) during long-term treatment of subjects with stable schizophrenia.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Alkermes, Inc.
Criteria
Inclusion Criteria:

(Subjects who participated in ALK9072-003)

- Completed the ALK9072-003 Day 85 visit

- Continues to require treatment with an antipsychotic medication

(New Subjects)

- On a stable dose of oral antipsychotic medication

- Diagnosis of chronic schizophrenia based on Diagnostic and Statistical Manual of
Mental Disorders, Fourth Edition (DSM-IV) criteria that is clinically stable

- Has been able to achieve outpatient status for more than 3 months prior to screening

- Body Mass Index (BMI) of 18.5 to 40.0 kg/m2 (inclusive)

- Resides in a stable living situation

Exclusion Criteria:

(Subjects who participated in ALK9072-003)

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

- Missed more than 1 scheduled study visit during participation in study ALK9072-003

- 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 in the next 12 months, or has pending legal action
which may impact compliance with study participation or procedures

(New Subjects)

- History of poor or inadequate clinical response to treatment with aripiprazole

- History of treatment resistance

- Diagnosis of current substance dependence (including alcohol)

- Pregnant, lactating, or breastfeeding

- Has received any long-acting intramuscular antipsychotic medication within 60 days
prior to screening

- Currently under involuntary hospitalization

- Current or expected incarceration

Additional inclusion/exclusion criteria may apply