Status:
COMPLETED
An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)
Lead Sponsor:
Alkermes, Inc.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 schiz...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
291 Patients enrolled
Trial Details
Trial ID
NCT01895452
Start Date
July 1 2013
End Date
June 1 2016
Last Update
August 25 2017
Active Locations (57)
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1
Alkermes Investigational Site
Little Rock, Arkansas, United States, 72201
2
Alkermes Investigational Site
Little Rock, Arkansas, United States, 72211
3
Alkermes Investigational Site
Garden Grove, California, United States, 92845
4
Alkermes Investigational Site
Oakland, California, United States, 94612