A Study in Healthy Subjects to Determine the Effects When Alcohol is Administered With Perampanel

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A Phase 1 study in healthy subjects to determine the safety, tolerability, psychomotor function, and cognitive effects of perampanel when administered alone and with alcohol.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02120365

Alcoholism

COMPLETED PHASE1/PHASE2

Alcohol Interaction Study

NCT01181908

Alcoholism

COMPLETED PHASE1

COMT Inhibition Among Individuals With Comorbid AUD/ADHD

NCT03904498

Alcohol Use Disorder Attention Deficit Hyperactivity Disorder

RECRUITING PHASE2

The Effects of Topiramate on Alcohol Use in Alcohol Dependent Subjects

NCT00329407

Alcoholism

COMPLETED PHASE4

A Multicenter, Randomized, Double-blind, Placebo-controlled, 3-parallel-group Comparison Trial to Investigate the Effect of Nalmefene on Alcohol Consumption Reduction in Patients With Alcohol Dependence (Phase 3 Trial)

NCT02364947

Alcohol Dependence

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Central Nervous System

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

alcohol + placebo

Part A alcohol + placebo

Group Type OTHER

alcohol + placebo

Intervention Type DRUG

Part A alcohol + placebo

alcohol + perampanel

Part A : alcohol + perampanel

Group Type OTHER

alcohol + perampanel

Intervention Type DRUG

Part A: alcohol + perampanel

perampanel + alcohol

Part B: perampanel + alcohol

Group Type OTHER

perampanel + alcohol

Intervention Type DRUG

Part B: perampanel + alcohol

placebo + alcohol

Part B: placebo + alcohol

Group Type OTHER

placebo + alcohol

Intervention Type DRUG

Part B: placebo + alcohol

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

alcohol + placebo

Part A alcohol + placebo

Intervention Type DRUG

alcohol + perampanel

Part A: alcohol + perampanel

Intervention Type DRUG

perampanel + alcohol

Part B: perampanel + alcohol

Intervention Type DRUG

placebo + alcohol

Part B: placebo + alcohol

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy male and female subjects
* Females agreed to use two medically acceptable methods of contraception, unless they were surgically sterile
* Aged 18-55 yrs, inclusive
* Achieved a Continuous Tracking Test (CTT )score increase of \>1.5 pixels from pre-alcohol when dosed with alcohol during the Screening Period (Day minus 8 plus/minus 2 days)
* Had a current driving license and drove regularly (e.g., more than 1000 miles a year (Part B only)

Exclusion:

* Any history of significant alcohol abuse or psychiatric disease, requiring inpatient admission or prolonged treatment with psychotropic medication
* Unable to follow the instructions for the psychometric testing
* Intolerant to the driving simulator (Part B only)
* Unable to adhere to long periods of confinement (subjects who could not follow the instructions of the protocol, including the meals)
* Use of prescription drugs or over-the-counter (OTC) medications within 2 weeks prior to Screening (unless drug had a long half life \[i.e., 5 x t 1/2\>2 weeks\]) with the exception of paracetamol (up to 4 g/day), which was allowed up to 12 hours prior to dosing
* Had taken any inhibitor of CYP450 within 2 weeks prior to the first dosing (e.g., grapefruit, grapefruit juice, grapefruit-containing beverages, or Seville orange products)
* Had taken St John's Wort or other dietary aids known to induce CYP3A4 within 4 weeks prior to dosing

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes