NCT02120365

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

Completed Phase 1, PHASE2 Results posted Last updated 18 August 2023

What this trial tests

Phase 1, PHASE2 trial testing Perampanel in Alcoholism in 22 participants. Completed in 16 February 2022.

Timeline

1 June 2019

Primary endpoint
15 February 2022

16 February 2022

Quick facts

Lead sponsor	Virginia Commonwealth University
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	treatment
Enrollment	22
Start date	1 June 2019
Primary completion	15 February 2022
Estimated completion	16 February 2022
Sites	4 locations across United States

Drugs / interventions tested

• Perampanel (PERAMPANEL) — full drug profile →
• Placebo

Conditions studied

• Alcoholism — all drugs for Alcoholism →

Sponsor

Virginia Commonwealth University

Who can join

Adults 21 to 70, any sex, with Alcoholism. 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.

Biphasic Alcohol Effects Scale (BAES): Stimulant Subscale Primary · 98 minutes

A 14-item scale with 7 items designed to assess stimulant effects from alcohol intoxication and 7 items developed to measure the sedative effects of alcohol. This scale was selected as a primary outcome measure because it is sensitive to the effect of alcohol. This outcome item reports the Stimulant Subscale results analyzed with mixed models. Each item can be scored a minimum of zero (0) or up to 10 with the 10 representing feeling more or the most intoxicated in that item's description (e.g., "excited"). The minimum score is 0 and the maximum score is 70. For the time frame, the values at di

Group	Value	95% CI
Placebo Medication Dose	13.756	± 2.747
Perampanel 6mg Dose	14.053	± 2.658
Perampanel 10mg Dose	13.026	± 2.816

Biphasic Alcohol Effects Scale (BAES)- Sedative Subscale Primary · 98 minutes

A 14-item scale with 7 items designed to assess stimulant effects from alcohol intoxication and 7 items developed to measure the sedative effects of alcohol. This scale was selected as a primary outcome measure because it is sensitive to the effect of alcohol. This entry item show the results for the sedative subscale evaluated in mixed models. Each item can be scored a minimum of zero (0) or up to 10 with the 10 representing feeling more or the most intoxicated in that item's description (e.g., "sedated"). The minimum score is 0 and the maximum score is 70. For the time frame, the values at d

Group	Value	95% CI
Placebo	4.624	± 1.784
Perampanel 6mg	7.159	± 1.649
Perampanel 10 mg	10.263	± 1.797

Drug Effects Questionaire (DEQ) Primary · 98 min

consists of four items that measure current alcohol effects: 'feel alcohol', 'feel high', 'like alcohol', and 'want more alcohol'. For the time frame, the values at different time points were combined (averaged) into a single value that represents the effect during the time interval of interest (12 to 110 minutes). There are five items on the scale with scores of 0 to 100, and the total score is used by averaging all five items, thus, the minimum total score on the scale is 0 and the maximum is 100. The lowest score 0 represents "not at all" or not experiencing any drug effects from alcohol, a

Group	Value	95% CI
Placebo Medication Dose	42.538	± 3.379
Perampanel 6mg Dose	40.619	± 3.269
Perampanel 10mg Dose	43.267	± 3.442

Alcohol Urge Questionnaire (AUQ) Secondary · 98 min

A valid eight-item Likert-type scale designed to assess acute alcohol craving. Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 are reverse scored. A total score is computed by averaging the item scores. Higher scores reflect greater craving. The minimum score is 7, and the maximum is 49. For the time frame, the values at different time points were combined (averaged) into a single value that represents the effect during the time interval of interest (12 to 110 minutes).

Group	Value	95% CI
Placebo Medication Dose	16.481	± 1.266
Perampanel 6mg Dose	17.314	± 1.177
Perampanel 10mg Dose	18.723	± 1.289

Side Effect Questionnaire (SEQ) Secondary · 98 minutes

This consists of a list of side effects associated with perampanel (e.g., fatigue, dizziness), rated from 0="none" to 4="severe". The mean for each subject across all items is included in each group/arm mean. The lowest score on the scale would be 0 and the maximum 4, as the mean across items is taken and not a sum. For the time frame, the values at different time points were combined (averaged) into a single value that represents the effect during the time interval of interest (12 to 110 minutes).

Group	Value	95% CI
Placebo Medication Dose	0.895	± .294
Perampanel 6mg Dose	.992	± .261
Perampanel 10mg Dose	1.13	± .280

Profile of Mood States (POMS) 2 Short Version Total Score Secondary · 98 minutes

The Profile of Mood States (POMS) 2 short version contains a subset of 35 items from the full-length versions. This subset comprises those five items on full version POMS scale that exhibited good item-total correlations and best predicted their respective scale scores, this is a TOTAL score Representing total mood disturbance. For the time frame, the values at different time points were combined (averaged) into a single value that represents the effect during the time interval of interest (12 to 110 minutes). The minimum is 0 and the maximum is 100 with higher numbers indicating greater mood

Group	Value	95% CI
Placebo Medication Dose	20.25	± 1.490
Perampanel 6mg Dose	21.75	± 1.335
Perampanel 10mg Dose	20.619	± 1.533

Adverse events — posted to ClinicalTrials.gov

Time frame: 40 days of participation. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 0/22 (0%)

Deaths: 0/22

Perampanel 6mg

Serious: 0/22 (0%)

Deaths: 0/22

Perampanel 10 mg

Serious: 0/22 (0%)

Deaths: 0/22

Other adverse events (6 terms — click to expand)

Reaction	System	Placebo	Perampanel 6mg	Perampanel 10 mg
nausea/vomiting	Gastrointestinal disorders	—	—	—
IV site bruising/thrombosis	Skin and subcutaneous tissue disorders	—	—	—
Viral cold symptoms	Infections and infestations	—	—	—
dysuria	Renal and urinary disorders	—	—	—
Dry Mouth	Gastrointestinal disorders	—	—	—
Fatigue	Psychiatric disorders	—	—	—

Data from ClinicalTrials.gov NCT02120365 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Allosteric Modulation of Ionotropic Glutamate Receptors: An Outlook on New Therapeutic Approaches To Treat Central Nervous System Disorders.
   Brogi S, Campiani G, Brindisi M, Butini S. · · 2019 · cited 31× · PMID 30891118 · DOI 10.1021/acsmedchemlett.8b00450