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NCT02511886 · ClinicalTrials.gov registry record · Phase 2
A Dose-Escalation Study to Determine the Maximum Tolerated Dose of Arbaclofen Placarbil in Subjects With Alcohol Use Disorder
A Phase 2 study, sponsored by Indivior.
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT02511886: Completed Phase 2 study, sponsored by Indivior.
NCT02511886 is a Phase 2 study that has completed, run by Indivior. The registered enrollment target is 18 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02511886, a Phase 2 study, has completed, sponsored by Indivior.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study Summary
This study will determine the maximum tolerated dose (MTD) of arbaclofen placarbil (AP) in the treatment of subjects with Alcohol Use Disorder (AUD). For every two subjects receiving AP, one subject will receive placebo.
Primary Outcome
A data monitoring committee (DMC) will review and make a recommendation to stop dosing escalation based on the review of the unblinded AE and safety assessments or when at least one subject on active investigational product experiences an SAE related to the investigational product. The MTD and the dosage that will not be exceeded in the further development of this compound will be based upon a comprehensive review of the safety data.
Interventions
- DRUG Placebo
- DRUG Arbaclofen Placarbil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2015-09 |
| Est. Completion | 2016-01 |
| Phase | Phase 2 |
What the finished NCT02511886 record still lists
NCT02511886 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02511886 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02511886 about?
NCT02511886 is a clinical study titled "A Dose-Escalation Study to Determine the Maximum Tolerated Dose of Arbaclofen Placarbil in Subjects With Alcohol Use Disorder". This study will determine the maximum tolerated dose (MTD) of arbaclofen placarbil (AP) in the treatment of subjects with Alcohol Use Disorder (AUD). For every two subjects receiving AP, one subject will receive placebo.
What is the current status of trial NCT02511886?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2015-09. Estimated completion is 2016-01.
What interventions are being tested in trial NCT02511886?
The interventions under investigation include: Placebo (DRUG), Arbaclofen Placarbil (DRUG).
Who is sponsoring clinical trial NCT02511886?
This trial is sponsored by Indivior, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02511886's enrollment target sits among peer trials
18 1898th of 2000 higher than 98 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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