ALK21-010: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol-dependent Adults

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00156923
• Date of registration: 07/09/2005
• Prospective Registration: No
• Primary sponsor: Alkermes, Inc.
• Public title: ALK21-010: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol-dependent Adults
• Scientific title: A Multi-Center Extension of Alkermes' Study ALK21-003-EXT (NCT01218971) to Evaluate the Long-Term Safety of Medisorb® Naltrexone
• Date of first enrolment: October 2003
• Target sample size: 108
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00156923
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Bernard L. Silverman, MD
• Affiliation: Alkermes, Inc.

Key inclusion & exclusion criteria

Primary Inclusion Criteria:

- Completed Study ALK21-003-EXT (NCT01218971), receiving all 13 injections

- Willing and able to return for scheduled clinic visits and study assessments

- Noncustodial, stable address and phone

- Written, informed consent

Primary Exclusion Criteria:

- Pregnancy or lactation

- Terminated early from study drug in Study ALK21-003-EXT (NCT01218971)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Alcoholism

Intervention(s)

Drug: Medisorb naltrexone 380 mg

Drug: Medisorb naltrexone 190 mg

Primary Outcome(s)

Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) [Time Frame: Up to 3.5 years of monthly treatment]

Secondary ID(s)

ALK21-010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 03/12/2010
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00156923