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

NCT04118829 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-09-16

No results posted yet for this study

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

Interventions

DRUG

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.

Sponsors & Collaborators

  • Carilion Clinic

    lead OTHER

Principal Investigators

  • Aashit Shah, MD · Physician

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2022-09-30
Completion
2023-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04118829 on ClinicalTrials.gov