Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831

Completed · Phase 3

Conditions studied: Schizophrenia, Schizophreniform Disorder, Bipolar I Disorder

In brief

This study will evaluate the long-term safety, tolerability, and durability of treatment effect of ALKS 3831 in subjects with schizophrenia, schizophreniform disorder, or bipolar I disorder

Key facts

Study ID

NCT03201757

Run by

Alkermes, Inc.

People needed

523

Starts

2017-06-15

Expected to finish

2023-09-06

Last updated by the study team

2024-09-26

Who can join

Age: 16 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Willing and able to give informed consent/assent as per local requirements
• Agrees to use an acceptable method of contraception during the study, and for 30 days after any study drug administration, unless surgically sterile or post-menopausal
• Has the potential to benefit from the administration of ALKS 3831, in the opinion of the investigator
• Subject met the eligibility criteria of the antecedent study at the time of enrollment in the antecedent study and completed the treatment period in one of the following antecedent studies within 7 days: ALK3831-A304, ALK3831-A306, or ALK3831-A307
• Additional criteria may apply

You may not qualify if…

• Has any finding that, in the view of the investigator or medical monitor, would compromise the safety of the subject or affect their ability to fulfill the protocol visit schedule or visit requirements
• Has a positive drug screen for drugs of abuse at study entry
• Currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration
• Additional criteria may apply

Where it is running

• Alkermes Investigational Site — Rogers, 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 — 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 — Palo Alto, 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 — Temecula, California, United States
• Alkermes Investigational Site — Torrance, California, 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 — Atlanta, Georgia, 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
• Alkermes Investigational Site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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