Recruiting

Perampanel

Sponsor:

Carilion Clinic

Code:

NCT04118829

Conditions

Epilepsy

Seizures

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Perampanel

Study Details

Brief summary:

Perampanel is a drug used to treat patients with epilepsy/seizures. This study is designed to determine how much perampanel actually crosses the blood brain barrier into the cerebral spinal fluid when the drug is taken.

Conditions

Epilepsy

Seizures

Study ID

NCT04118829

Start date

Nov 1, 2019

Status verified date

Sep, 2021

Completion date

Mar, 2023

Anticipated

Primary completion date

Sep, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults (>18 years-old) who are scheduled to undergo brain surgery and need antiepileptic medication for prophylaxis or treatment of seizures
  • Able to provide informed consent

Exclusion Criteria:

  • Patient unable to provide informed consent
  • Allergy to PER or its component
  • Patient with significant renal (creatinine clearance 35 ml/min) or hepatic impairment
  • Pregnant or lactating females will be excluded from the study.

Study Design

Enrollment

25 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group one

The Group 1 patients will be taking PER up to 14 days following surgical intervention as per discretion of the treating neurosurgeon.

experimental: Group Two

The Group 2 patients will be taking PER as part of their maintenance AED regimen and will continue on the same maintenance dosage postoperatively.

Interventions

Perampanel

For group 1 the PER dose will be administered 2-14 hours prior to sample collection. They will be administered a single dose of PER (8 mg, 12 mg or 16 mg) followed by 4 mg/day for 14 days starting on postoperative day 1 (if continued prophylaxis with PER is needed).

It is anticipated that patients in group 2 will have the daily dose of PER in these individuals will range from 4 - 12 mg/day.

Primary outcome measure

  • Blood brain barrier serum levels [ Time Frame: 3 weeks ]

Central Contacts and Locations

Central contacts

Jordan Darden, PhD

540-981-7942jadarden@carilionclinic.org

Locations

Carilion Clinic

Recruiting

Roanoke, Virginia, United States, 24016

Contacts

Jordan Darden, PhD

540-981-7942jadarden@carilionclinic.org

Ruth Ndolo, RN

540-519-3428rmndolo@carilionclinic.org

More Information

Sponsor

Carilion Clinic

Last update posted

Sep 16, 2021

Last verified

Sep, 2021

Keywords

  • Perampanel

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Carilion Clinic on 2021-09-16.