Alcoholism
Conditions
Keywords
Alcohol dependence
Brief summary
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®).
Detailed 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.
Interventions
Administered via intramuscular (IM) injection once every 4 weeks for up to 3.5 years.
Administered via IM injection once every 4 weeks for up to 3.5 years.
Sponsors
Alkermes, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) | Up to 3.5 years of monthly treatment | A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration in this extension through the end of the follow-up period). |
Participant flow
Recruitment details
Subjects who successfully completed Alkermes' Study ALK21-003EXT (NCT01218971) and who continued to meet eligibility criteria were given the option to enroll into this extension study.
Participants by arm
| Arm | Count |
|---|---|
| Medisorb Naltrexone 380 mg Administered via intramuscular (IM) injection once every 4 weeks. | 56 |
| Medisorb Naltrexone 190 mg Administered via IM injection once every 4 weeks. | 52 |
| Total | 108 |
Baseline characteristics
| Characteristic | Medisorb Naltrexone 190 mg | Medisorb Naltrexone 380 mg | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 3 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 47 Participants | 53 Participants | 100 Participants |
| Age, Continuous | 48.1 years STANDARD_DEVIATION 10 | 45.9 years STANDARD_DEVIATION 9 | 46.9 years STANDARD_DEVIATION 9.5 |
| Region of Enrollment United States | 52 participants | 56 participants | 108 participants |
| Sex: Female, Male Female | 20 Participants | 19 Participants | 39 Participants |
| Sex: Female, Male Male | 32 Participants | 37 Participants | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 51 / 56 | 49 / 52 |
| serious Total, serious adverse events | 9 / 56 | 9 / 52 |
Outcome results
Primary
Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE)
A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration in this extension through the end of the follow-up period).
Time frame: Up to 3.5 years of monthly treatment
Population: Subjects who received at least 1 injection of study drug were included in the safety analyses
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medisorb Naltrexone 380 mg | Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) | 49 Participants |
| Medisorb Naltrexone 190 mg | Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) | 51 Participants |