Adults 21 to 70, any sex, with Alcohol Disorders. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percent Abstinent DaysPrimary· End of treatment, up to 12 weeks
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.
Group
Value
95% CI
Perampanel by Itself
3.13
0 – 6.25
Perapanel With Disulfiram
100
100 – 100
Change in Alcohol CravingSecondary· Baseline to end of treatment, up to 12 weeks
Alcohol craving will be assessed using the Alcohol Urge Questionnaire (AUG). The AUG is an 8-item survey asking participants to rate their craving for alcohol on a 1 to 7 scale. The answers are summed yielding a score ranging from 7 to 56 with higher scores indicated higher alcohol craving.
Group
Value
95% CI
Perampanel by Itself
4
2 – 6
Perapanel With Disulfiram
-1
-2 – 0
Percent Heavy Drinking DaysSecondary· End of treatment, Up to 8 weeks
Participant will report the number of alcoholic drinks they consumed during the previous weeks period. Based on participant report, the percent of days the participant drank heavily will be calculated over the 8 week active treatment period.
Group
Value
95% CI
Perampanel by Itself
73.60
65.6 – 81.6
Perapanel With Disulfiram
0
0 – 0
Adverse events — posted to ClinicalTrials.gov
Time frame: At baseline and weekly for eight weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT04015141 — A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants Wi
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Virginia Commonwealth University
Last refreshed: 7 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04502589.