Alcohol DependencePhase 3NCT01218971
ALK21-003EXT: An Extension of Study ALK21-003 (NCT01218958) to Test the Long-term Safety of Medisorb® Naltrexone (VIVITROL®)
A Phase 3 study testing Medisorb naltrexone 190 mg and Medisorb naltrexone 380 mg in people with Alcohol Dependence, run by Alkermes, Inc..
Trial summary
This was a Phase 3 multicenter extension of Alkermes' Study ALK21-003 (NCT01218958 [the base study]) that evaluated the safety of Medisorb® naltrexone (VIVITROL®) administered every 4 weeks for 48 weeks (13 injections) in alcohol-dependent adults who had completed Study ALK21-003. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- Medisorb naltrexone 190 mg and Medisorb naltrexone 380 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- No sites listed yet
- Study dates
- Aug 2002to Sep 2004
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Primary Inclusion Criteria:
- Completed study drug treatment in Study ALK21-003 (base study [NCT01218958])
- Written informed consent for this extension study
- Stable address and telephone; reconfirmation of contact's address and phone
- Women with childbearing potential must agree to continue to use an approved method of birth control throughout study participation
Primary Exclusion Criteria:
- Positive urine drug screen for opioids at Visit 1
- Early termination of study drug in the base study
- Pregnancy or lactation
About this study
Official title: A Multicenter Double-Blind Extension of Alkermes Study ALK21-003 to Evaluate the Long-Term Safety of Medisorb® Naltrexone
This was a Phase 3 multicenter extension of Alkermes' Study ALK21-003 (NCT01218958 [the base study]) that evaluated the safety of Medisorb® naltrexone (VIVITROL®) administered every 4 weeks for 48 weeks (13 injections) in alcohol-dependent adults who had completed Study ALK21-003.
Read the detailed description
All participants in this study received Medisorb naltrexone at double-blinded dose strengths (ie, 190 mg or 380 mg); no participant received placebo. Participants who had received Medisorb naltrexone in Study ALK21-003 (NCT01218958) continued to receive the same dose strength in this extension study. Those who had received placebo for Medisorb naltrexone 190 mg in the base study were given Medisorb naltrexone 190 mg. Participants who had received placebo for Medisorb naltrexone 380 mg in the base study were given Medisorb naltrexone 380 mg.
Neither the identity or dose of the treatment received in the base study, nor the Medisorb naltrexone dose strength (190 mg or 380 mg) received in this extension were revealed to any participant, the investigator, or any blinded member of the clinical study team during the conduct of the base study or this extension.
All participants were encouraged to receive standardized biopsychosocial support at each clinic visit throughout the study; however, unlike the base study, participation was not mandatory.
Participants eligible for this extension study had received all 6 injections of study drug in the base study; those who received Medisorb naltrexone in the base study who also received all 13 injections in this extension therefore had a duration of exposure of approximately 76 weeks (~1.5 years) upon completion of this extension. For participants who had received placebo in the base study, maximum duration of exposure was approx. 48 weeks (1 year).
- Conditions
- Alcohol Dependence
- Being tested
- Medisorb naltrexone 190 mg, Medisorb naltrexone 380 mg
- Keywords
- Alcohol Dependence
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medisorb naltrexone 190 mgDrug
naltrexone for extended-release injectable suspension
Medisorb naltrexone 380 mgDrug
Also called VIVITROL
naltrexone for extended-release injectable suspension
| Study group | Role | What they receive |
|---|---|---|
| Medisorb naltrexone 380 mg | Experimental | Intramuscular (IM) injection administered once every 4 weeks for up to 48 weeks. Receives: Drug: Medisorb naltrexone 380 mg |
| Medisorb naltrexone 190 mg | Experimental | IM injection administered once every 4 weeks for up to 48 weeks. Receives: Drug: Medisorb naltrexone 190 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While in Study
A TEAE is any adverse event, whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).
Measured: Up to 48 weeks (13 injections), not including base study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startAug 2002
- Primary completionSep 2004
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bernard L Silverman, MD, Study director, Alkermes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01218971
- Sponsor's protocol ID
- ALK21-003-EXT
- Status last verified
- Dec 2010
- First submitted
- 8 Oct 2010
- Last updated
- 24 Dec 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Double-Blind Extension of Alkermes Study ALK21-003 to Evaluate the Long-Term Safety of Medisorb® Naltrexone
- ClinicalTrials.gov ID
- NCT01218971
- Acronym / sponsor ID
- ALK21-003-EXT
- Conditions
- Alcohol Dependence
- Keywords
- Alcohol Dependence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2002
- Primary completion
- Sep 2004 (actual)
- Study completion
- Sep 2004 (actual)
- First posted
- 13 Oct 2010 (estimated)
- Results
- Posted 8 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a Phase 3 multicenter extension of Alkermes' Study ALK21-003 (NCT01218958 [the base study]) that evaluated the safety of Medisorb® naltrexone (VIVITROL®) administered every 4 weeks for 48 weeks (13 injections) in alcohol-dependent adults who had completed Study ALK21-003.
Detailed description
All participants in this study received Medisorb naltrexone at double-blinded dose strengths (ie, 190 mg or 380 mg); no participant received placebo. Participants who had received Medisorb naltrexone in Study ALK21-003 (NCT01218958) continued to receive the same dose strength in this extension study. Those who had received placebo for Medisorb naltrexone 190 mg in the base study were given Medisorb naltrexone 190 mg. Participants who had received placebo for Medisorb naltrexone 380 mg in the base study were given Medisorb naltrexone 380 mg.
Neither the identity or dose of the treatment received in the base study, nor the Medisorb naltrexone dose strength (190 mg or 380 mg) received in this extension were revealed to any participant, the investigator, or any blinded member of the clinical study team during the conduct of the base study or this extension.
All participants were encouraged to receive standardized biopsychosocial support at each clinic visit throughout the study; however, unlike the base study, participation was not mandatory.
Participants eligible for this extension study had received all 6 injections of study drug in the base study; those who received Medisorb naltrexone in the base study who also received all 13 injections in this extension therefore had a duration of exposure of approximately 76 weeks (~1.5 years) upon completion of this extension. For participants who had received placebo in the base study, maximum duration of exposure was approx. 48 weeks (1 year).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medisorb naltrexone 380 mg | Experimental | Drug: Medisorb naltrexone 380 mgIntramuscular (IM) injection administered once every 4 weeks for up to 48 weeks. |
| Medisorb naltrexone 190 mg | Experimental | Drug: Medisorb naltrexone 190 mgIM injection administered once every 4 weeks for up to 48 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medisorb naltrexone 190 mgnaltrexone for extended-release injectable suspension | Drug | Medisorb naltrexone 190 mg |
| Medisorb naltrexone 380 mgAlso: VIVITROLnaltrexone for extended-release injectable suspension | Drug | Medisorb naltrexone 380 mg |
Primary outcome
Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While in Study
Time frame: Up to 48 weeks (13 injections), not including base study
A TEAE is any adverse event, whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- ThirdAge\[TM\]: Alcohol abuse and alcoholism clinical trials listingLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard L Silverman, MD study director
Alkermes, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Medisorb naltrexone 190 mg and Medisorb naltrexone 380 mg in people with Alcohol Dependence, run by Alkermes, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While in Study (time frame: Up to 48 weeks (13 injections), not including base study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2010.