CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 4 enrolled
Drug / intervention
Perampanel Tablet +1 moredrug
Likely dose
Perampanel Tablet 8mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04502589
NCT04502589Phase 2Completed
CompareCT.gov

Open Label Pilot Study of Perampanel for the Treatment of Alcohol Use Disorder

Virginia Commonwealth University·interventional·Posted Aug 6, 2020·Updated Oct 7, 2022

In Brief

A Phase 2 clinical trial evaluating Perampanel Tablet and Disulfiram for Alcohol Disorders. Completed, enrolled 4 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol Disorders
CountriesUnited States
CollaboratorsNational Institute on Alcohol Abuse and Alcoholism (NIAAA)

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedAug 6, 2020
Enrollment StartOct 15, 2020
Primary CompletionAug 11, 2021
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 5.9 years ago

Interventions

Perampanel Tabletdrug

Subjects will be titrated over 3 weeks to a target dose of 8mg perampanel daily in both groups

Disulfiramdrug

Disulfiram will be kept at 250mg daily