A Phase 3, 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

NCT02873208

Run by

Alkermes, Inc.

People needed

266

Starts

2016-08-07

Expected to finish

2019-10-17

Last updated by the study team

2021-07-21

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Agrees to use an acceptable method of contraception for the duration of the study
• Subject has completed the 24-week treatment period in the antecedent study, ALK3831-A303, within 7 days
• Additional criteria may apply

You may not qualify if…

• Subject is currently taking medications that are contraindicated with olanzapine use or exhibit drug-interaction potential with olanzapine
• 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 — Anaheim, California, United States
• Alkermes Investigational Site — Cerritos, California, United States
• Alkermes Investigational Site — Culver City, California, United States
• Alkermes Investigational Site — Garden Grove, California, United States
• Alkermes Investigational Site — Glendale, California, United States
• Alkermes Investigational Site — Lemon Grove, California, United States
• Alkermes Investigational Site — Long Beach, 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 — Pico Rivera, California, United States
• Alkermes Investigational Site — Redlands, California, United States
• Alkermes Investigational Site — San Diego, California, United States
• Alkermes Investigational Site — San Diego, California, United States
• Alkermes Investigational Site — Temecula, California, United States
• Alkermes Investigational Site — Torrance, California, United States
• Alkermes Investigational Site — Hollywood, Florida, United States
• Alkermes Investigational Site — Lauderhill, Florida, United States
• Alkermes Investigational Site — North Miami, Florida, United States
• Alkermes Investigational Site — Atlanta, Georgia, United States
• Alkermes Investigational Site — Augusta, Georgia, United States
• Alkermes Investigational Site — Decatur, Georgia, United States
• Alkermes Investigational Site — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.