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

NCT04502589 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: HM20015846R21AA026681
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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

Alcohol Disorders

Outcome Measures

Primary Outcomes (1)

• Percent Abstinent Days

  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.

  End of treatment, up to 12 weeks

Secondary Outcomes (2)

• Change in Alcohol Craving

  Baseline to end of treatment, up to 12 weeks

• Percent Heavy Drinking Days

  End of treatment, Up to 8 weeks

Study Arms (2)

perampanel by itself

ACTIVE COMPARATOR

Drug: Perampanel Tablet

Perapanel with Disulfiram

ACTIVE COMPARATOR

Drug: Perampanel Tablet; Drug: Disulfiram

Interventions

Perampanel Tablet DRUG

Subjects will be titrated over 3 weeks to a target dose of 8mg perampanel daily in both groups

Perapanel with Disulfiram; perampanel by itself

Disulfiram DRUG

Disulfiram will be kept at 250mg daily

Perapanel with Disulfiram

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women ages 21-70 with DSM-5 AUD;
• regular heavy drinkers as defined by averaging ≥ 2 heavy drinking days per week over the 60 days baseline pre-treatment TLFB, and recognize a need to completely stop drinking;
• willingness to provide written, informed consent to participate in the study;
• Individuals with LFTs that are no more than 2-3 times above the normal levels and with a Child-Pugh score of no greater than 5 will be included and
• women of child-bearing potential (i.e., no hysterectomy, bilateral oophorectomy, or tubal ligation or \<2 years postmenopausal), must be non-lactating, practicing a reliable method of birth control, and have a negative serum pregnancy test prior to initiation of treatment.

You may not qualify if:

• a current, clinically significant physical disease \[i.e., neurologic, renal, pulmonary, cardiovascular, hepatic\] on the basis of medical history, physical examination, or routine laboratory evaluation that, in the context of the study would represent a risk to the subject, or significant laboratory abnormalities related to hepatic function such as marked elevations of hepatic aminotransferase levels (i.e., AST and ALT) or direct bilirubin;
• history of renal compromise or current renal disease (as evidenced by serum creatinine above our laboratory's reference limit of 1.7 mg/dL;
• history of seizure disorder;
• use of any of a number of medications that might prominently influence drinking patterns or cause risk of harm or injury (e.g., other anticonvulsants, medications to treat AUD, opioid pain medication), currently taking CNS depressants (e.g. benzodiazepines, barbiturates, sedating antihistamines;
• schizophrenia, bipolar disorder, current major depressive episode, or substantial suicide or violence risk on the basis of history or psychiatric examination;
• currently dependent on stimulants, opioids or sedatives;
• subjects with any substantial alcohol withdrawal will be required to be detoxified by regular clinical services prior to study entry;
• are currently taking any medication that is a moderate to strong CYP3A4 inhibitor or inducer if participants are required to initiate these medications by an outside provider during the course of this study, they will be tapered off the study regimen and we will have them terminate early)
• are taking phenytoin or warfarin

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Virginia Commonwealth University Inst. for Drug and Alcohol Studies

Richmond, Virginia, 23219, United States

Location

MeSH Terms

Conditions

Alcohol-Related Disorders

Interventions

perampanel; Disulfiram

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Ditiocarb; Thiocarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Disulfides; Sulfides; Sulfur Compounds

Results Point of Contact

• Title: Albert Arias, M.D.
• Organization: Virginia Commonwealth University

albert.arias@vcuhealth.org

(804) 828-5793

Study Officials

• Albert Arias, MD, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 20 subjects with AUD will be randomized 1:1 to one of two groups; perampanel by itself, and perampanel combined with disulfiram.

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 6, 2020
• Study Start: October 15, 2020
• Primary Completion: August 11, 2021
• Study Completion: August 11, 2021
• Last Updated: October 7, 2022
• Results First Posted: October 7, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)