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COMPLETED Phase 1

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

NCT04502589 · View on ClinicalTrials.gov ↗

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.

Conditions Studied

Interventions

  • DRUG Disulfiram
  • DRUG Perampanel Tablet

Study Locations (1)

Virginia

  • Virginia Commonwealth University Inst. for Drug and Alcohol Studies — Richmond

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2020-10-15
Est. Completion 2021-08-11
Phase Phase 1

Sponsor

Virginia Commonwealth University

513 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04502589

The ClinicalTrials.gov registry entry for NCT04502589 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Virginia Commonwealth University, which has 513 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04502589 reports 1 study location spanning 1 distinct geographic area — top geographies include Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04502589?

The interventions under investigation include: Disulfiram (DRUG), Perampanel Tablet (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04502589?

This trial is sponsored by Virginia Commonwealth University, which has 513 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial