A Long-Term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia

Completed · Phase 3

Conditions studied: Schizophrenia

In brief

The primary objective of this study is to evaluate the long term safety and tolerability of ALKS 3831 in subjects with schizophrenia.

Key facts

Study ID

NCT02669758

Run by

Alkermes, Inc.

People needed

281

Starts

2016-01-20

Expected to finish

2018-06-29

Last updated by the study team

2019-07-26

Who can join

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

You may qualify if…

• Subject has completed the 4-week treatment period (all visits up to and including end of treatment visit) in the antecedent study ALK3831-A305 within 7 days.
• Agrees to use an acceptable method of contraception for the duration of the study.
• Additional criteria may apply.

You may not qualify if…

• Subject is currently taking medications that are contraindicated with olanzapine use.
• Subject has a positive test for drugs of abuse at study entry.
• Subject is pregnant, planning to become pregnant, or breastfeeding during the study.
• Additional criteria may apply.

Where it is running

• Alkermes Investigational Site — Little Rock, Arkansas, United States
• Alkermes Investigational Site — Springdale, Arkansas, United States
• Alkermes Investigational Site — Culver City, California, United States
• Alkermes Investigational Site — Garden Grove, California, United States
• Alkermes Investigational Site — Lemon Grove, California, United States
• Alkermes Investigational Site — Orange, California, United States
• Alkermes Investigational Site — San Diego, California, United States
• Alkermes Investigational Site — Miami, Florida, United States
• Alkermes Investigational Site — Chicago, Illinois, United States
• Alkermes Investigational Site — St Louis, Missouri, United States
• Alkermes Investigational Site — Las Vegas, Nevada, United States
• Alkermes Investigational Site — Marlton, New Jersey, United States
• Alkermes Investigational Site — Dayton, Ohio, United States
• Alkermes Investigational Site — Dallas, Texas, United States
• Alkermes Investigational Site — Burgas, Bulgaria
• Alkermes Investigational Site — Kazanlak, Bulgaria
• Alkermes Investigational Site — Lovech, Bulgaria
• Alkermes Investigational Site — Novi Iskar, Bulgaria
• Alkermes Investigational Site — Plovdiv, Bulgaria
• Alkermes Investigational Site — Sofia, Bulgaria
• Alkermes Investigational Site — Tserova Koria, Bulgaria
• Alkermes Investigational Site — Veliko Tarnovo, Bulgaria
• Alkermes Investigational Site — Vratsa, Bulgaria
• Alkermes Investigational Site — Belgrade, Serbia
• Alkermes Investigational Site — Kragujevac, Serbia

Full record on ClinicalTrials.gov

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