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

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Alkermes

Status and phase

Completed
Phase 3

Conditions

Alcoholism

Treatments

Drug: Medisorb naltrexone 190 mg
Drug: Medisorb naltrexone 380 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT00156923
ALK21-010

Details and patient eligibility

About

This was a Phase 3, multi-center extension of Alkermes' Study ALK21-003EXT (NCT01218971) to further assess the long-term safety of repeat monthly doses of Medisorb® naltrexone (VIVITROL®).

Full description

Enrolled subjects continued to receive the same dose strength of Medisorb naltrexone (ie, 190 mg or 380 mg) they had received in Study ALK21-003-EXT (NCT01218971). Assigned dose strength (high or low) was not revealed to the subject, the study investigators, or any blinded member of the clinical study team for the duration of the study period. Placebo was not administered.

Enrollment

108 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and 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)

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

108 participants in 2 patient groups

Medisorb naltrexone 380 mg
Experimental group
Treatment:
Drug: Medisorb naltrexone 380 mg
Medisorb naltrexone 190 mg
Experimental group
Treatment:
Drug: Medisorb naltrexone 190 mg

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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