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drugset / Trial / NCT02120365

Rapid Determination Of The Clinical Utility Of Perampanel For The Treatment Of Alcohol Dependence

NCT02120365 ↗

Phase 1/2 Completed 22 enrolled Virginia Commonwealth University National Institute on Alcohol Abuse and Alcoholism (NIAAA) · collabUniversity of Connecticut · collabYale University · collab
RandomizedCrossoverTriple-blindTreatment

Summary

The purpose of this study is to determine whether perampanel alters the response to alcohol for heavy drinkers. It is hypothesized that perampanel will reduce the rewarding and reinforcing properties of alcohol in the laboratory setting.

Timeline

Start
2019-06-01
Primary completion
2022-02-15
Completion
2022-02-16

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo Medication Dose vs Perampanel 6mg Dose vs Perampanel 10mg Dose; p = 0.867; NCT02120365 ↗

registry analysis (superiority test); Placebo vs Perampanel 6mg vs Perampanel 10 mg; p = 0.071; NCT02120365 ↗

registry analysis (superiority test); Placebo Medication Dose vs Perampanel 6mg Dose vs Perampanel 10mg Dose; p = 0.667; NCT02120365 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Perampanel Small molecule 6 mg —
Subject Perampanel Small molecule 10 mg —

Indications

alcohol dependence