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Perampanel Titration and Cognitive Effects

NCT04417907 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2024-06-06

Study results available
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Summary

The objective of this study is to determine whether there are any differences in the cognitive abilities and/or behavioral response of normal healthy volunteers across different titration rates of perampanel.

Conditions

Interventions

DRUG

Perampanel 1 week titration

Healthy adults will take 2mg perampanel PO QD for one week followed 4mg perampanel PO QD for five weeks.

DRUG

Perampanel 2 week titration

Healthy adults will take 2mg perampanel PO QD for two weeks followed 4mg perampanel PO QD for four weeks.

DRUG

Perampanel 4mg

Healthy adults will take 4mg perampanel PO QD for six weeks

DRUG

Placebo

Healthy adults will take 2mg placebo PO QD for six weeks

Sponsors & Collaborators

  • Eisai Inc.

    collaborator INDUSTRY

  • Kimford Jay Meador

    lead OTHER

Principal Investigators

  • Kimford Meador, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-20
Primary Completion
2023-05-01
Completion
2023-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT04417907 on ClinicalTrials.gov