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

NCT04502589 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2022-10-07

Study results available
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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.

Conditions

  • Alcohol Disorders

Interventions

DRUG

Perampanel Tablet

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

DRUG

Disulfiram

Disulfiram will be kept at 250mg daily

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Albert Arias, MD, PhD · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-15
Primary Completion
2021-08-11
Completion
2021-08-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04502589 on ClinicalTrials.gov