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NCT02120365 · ClinicalTrials.gov registry record · Phase 1
Rapid Determination Of The Clinical Utility Of Perampanel For The Treatment Of Alcohol Dependence
A Phase 1 study of Alcoholism, sponsored by Virginia Commonwealth University.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 4
- Study locations
NCT02120365: Completed Phase 1 study of Alcoholism, sponsored by Virginia Commonwealth University.
NCT02120365 is a Phase 1 study of Alcoholism that has completed, run by Virginia Commonwealth University. The registered enrollment target is 22 participants, below the 375-participant average among 65 other Alcoholism trials with a reported enrollment target (94% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02120365, a Phase 1 study of Alcoholism, has completed, sponsored by Virginia Commonwealth University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of this study is to determine whether perampanel alters the response to alcohol for heavy drinkers. It is hypothesized that perampanel will reduce the rewarding and reinforcing properties of alcohol in the laboratory setting.
Primary Outcome
A 14-item scale with 7 items designed to assess stimulant effects from alcohol intoxication and 7 items developed to measure the sedative effects of alcohol. This scale was selected as a primary outcome measure because it is sensitive to the effect of alcohol. This outcome item reports the Stimulant Subscale results analyzed with mixed models. Each item can be scored a minimum of zero (0) or up to 10 with the 10 representing feeling more or the most intoxicated in that item's description (e.g.,
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Perampanel
Study Locations (4)
Connecticut
- University of Connecticut - Farmington
- Yale New Haven Hospital Research Unit - New Haven
- West Haven Veterans Affairs - West Haven
Virginia
- Albert Arias - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2019-06-01 |
| Est. Completion | 2022-02-16 |
| Phase | Phase 1 |
What the finished NCT02120365 record still lists
NCT02120365 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 375-participant average among 65 other Alcoholism trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Alcoholism appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02120365 reports a single indexed study location in Connecticut, Virginia.
Frequently Asked Questions
What is clinical trial NCT02120365 about?
NCT02120365 is a clinical study titled "Rapid Determination Of The Clinical Utility Of Perampanel For The Treatment Of Alcohol Dependence". The purpose of this study is to determine whether perampanel alters the response to alcohol for heavy drinkers. It is hypothesized that perampanel will reduce the rewarding and reinforcing properties of alcohol in the laboratory setting.
What is the current status of trial NCT02120365?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2019-06-01. Estimated completion is 2022-02-16.
What conditions does trial NCT02120365 study?
This clinical trial studies the following conditions: Alcoholism.
What interventions are being tested in trial NCT02120365?
The interventions under investigation include: Placebo (DRUG), Perampanel (DRUG).
Who is sponsoring clinical trial NCT02120365?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02120365 being conducted?
This trial has 4 study locations across Connecticut, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alcoholism
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02120365's enrollment target sits among peer trials
22 63rd of 65 higher than 3 of 65 other Alcoholism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcoholism 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.
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