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

Completed · Phase 3

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT01895452

Run by

Alkermes, Inc.

People needed

291

Starts

2013-07-01

Expected to finish

2016-06-01

Last updated by the study team

2017-08-25

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Alkermes Investigational Site — Little Rock, Arkansas, United States
• Alkermes Investigational Site — Garden Grove, California, United States
• Alkermes Investigational Site — Oakland, California, United States
• Alkermes Investigational Site — Oceanside, California, United States
• Alkermes Investigational Site — Orange, California, United States
• Alkermes Investigational Site — Washington D.C., District of Columbia, United States
• Alkermes Investigational Site — Fort Lauderdale, Florida, United States
• Alkermes Investigational Site — Leesburg, Florida, United States
• Alkermes Investigational Site — Atlanta, Georgia, United States
• Alkermes Investigational Site — Chicago, Illinois, United States
• Alkermes Investigational Site — Chicago, Illinois, United States
• Alkermes Investigational Site — Hoffman Estates, Illinois, United States
• Alkermes Investigational Site — Shreveport, Louisiana, United States
• Alkermes Investigational Site — Oklahoma City, Oklahoma, United States
• Alkermes Investigational Site — Dallas, Texas, United States
• Alkermes Investigational Site — Dallas, Texas, United States
• Alkermes Investigational Site — Burgas, Bulgaria
• Alkermes Investigational Site — Novi Iskar, Bulgaria
• Alkermes Investigational Site — Pazardzhik, Bulgaria
• Alkermes Investigational Site — Plovdiv, Bulgaria
• Alkermes Investigational Site — Sofia, Bulgaria
• Alkermes Investigational Site — Targovishte, Bulgaria
• Alkermes Investigational Site — Veliko Tarnovo, Bulgaria
• Alkermes Investigational Site — Vratsa, Bulgaria
• Alkermes Investigational Site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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