Correlation of Serum Level of Perampanel (PER) Level to Cerebrospinal Fluid (CSF) Levels of PER

NCT04118829 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: IRB-19-347
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

Perampanel

Outcome Measures

Primary Outcomes (1)

• Blood brain barrier serum levels

  To determine the blood brain barrier(BBB) penetration of PER by measuring ratio of serum level to that of CSF measured on simultaneously obtained samples

  3 weeks

Study Arms (2)

Group one

EXPERIMENTAL

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

Drug: Perampanel

Group Two

EXPERIMENTAL

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

Drug: Perampanel

Interventions

Perampanel DRUG

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.

Group Two; Group one

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carilion Clinic: lead

Study Sites (1)

Carilion Clinic

Roanoke, Virginia, 24016, United States

RECRUITING

MeSH Terms

Conditions

Epilepsy; Seizures

Interventions

perampanel

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aashit Shah, MD

  Physician

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordan Darden, PhD

CONTACT

540-981-7942; jadarden@carilionclinic.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Neurology

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: October 8, 2019
• Study Start: November 1, 2019
• Primary Completion: September 1, 2022
• Study Completion: March 1, 2023
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)