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NCT04502589 · ClinicalTrials.gov registry record · Phase 1
Open Label Pilot Study of Perampanel for the Treatment of Alcohol Use Disorder
A Phase 1 study of Alcohol Disorders, sponsored by Virginia Commonwealth University.
- Completed
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
- 1
- Study location
NCT04502589: Completed Phase 1 study of Alcohol Disorders, sponsored by Virginia Commonwealth University.
NCT04502589 is a Phase 1 study of Alcohol Disorders that has completed, run by Virginia Commonwealth University. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04502589, a Phase 1 study of Alcohol Disorders, has completed, sponsored by Virginia Commonwealth University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research study is to test the safety, tolerability, and effectiveness of the drug Perampanel when used in persons who drink and wish to stop drinking. Perampanel has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of seizures but has not yet been approved to treat alcohol use disorders. For this reason, it is considered an investigational drug. Some people in this study will receive Perampanel alone and some people will receive Perampanel and Disulfiram, this will be determined by the pharmacy.
Primary Outcome
Participant will report the number of alcoholic drinks they consumed during the previous weeks period. Participants will be accessed for the full 12 week titration plus treatment period. However, for the purposes of the study, the percent of days the participant was abstinent will be calculated and reported only for the 8 week active treatment period.
Conditions Studied
Interventions
- DRUG Disulfiram
- DRUG Perampanel Tablet
Study Locations (1)
Virginia
- Virginia Commonwealth University Inst. for Drug and Alcohol Studies - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2020-10-15 |
| Est. Completion | 2021-08-11 |
| Phase | Phase 1 |
What the finished NCT04502589 record still lists
NCT04502589 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Alcohol Disorders appearing as the primary indexed condition, and to 2 interventions - of which Disulfiram is the first listed.
NCT04502589 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT04502589 about?
NCT04502589 is a clinical study titled "Open Label Pilot Study of Perampanel for the Treatment of Alcohol Use Disorder". The purpose of this research study is to test the safety, tolerability, and effectiveness of the drug Perampanel when used in persons who drink and wish to stop drinking. Perampanel has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of seizures but has not yet been ap...
What is the current status of trial NCT04502589?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2020-10-15. Estimated completion is 2021-08-11.
What conditions does trial NCT04502589 study?
This clinical trial studies the following conditions: Alcohol Disorders.
What interventions are being tested in trial NCT04502589?
The interventions under investigation include: Disulfiram (DRUG), Perampanel Tablet (DRUG).
Who is sponsoring clinical trial NCT04502589?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04502589 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04502589's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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