Perampanel Titration and Cognitive Effects

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-20

Study Completion Date

2023-05-01

Brief Summary

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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.

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Detailed Description

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This is a randomized, double-blind, parallel group design across different titration rates of perampanel in healthy volunteers. The study consists of 8 visits, 4 of which will occur at the participant's home, over a 7-week period. One hundred and three (103) normal healthy subjects will be treated with perampanel (PER) at one of four different titration rates: (1) 2mg/day PER for one week followed by 4mg/day PER for five weeks, (2) 2mg/day PER for two weeks followed by 4mg/day PER for four weeks, (3) 4mg/day PER for six weeks, or (4) placebo (0mg/day PER) for six weeks. Cognitive and behavioral function testing along with safety testing will be conducted at screening, pretreatment baseline, the end of each week during the titration and maintenance period.

Conditions

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Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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PER 1 Week Titration

Participants will take 2mg perampanel PO QD for one week, followed by 4mg perampanel PO QD for five weeks.

Group Type EXPERIMENTAL

Perampanel 1 week titration

Intervention Type DRUG

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

PER 2 Week Titration

Participants will take 2mg perampanel PO QD for two weeks, followed by 4mg perampanel PO QD for four weeks.

Group Type EXPERIMENTAL

Perampanel 2 week titration

Intervention Type DRUG

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

PER 4 mg

Participants will take 4mg perampanel PO QD for six weeks

Group Type EXPERIMENTAL

Perampanel 4mg

Intervention Type DRUG

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

Placebo

Participants will take 2mg placebo PO QD for six weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Perampanel 1 week titration

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

Intervention Type DRUG

Perampanel 2 week titration

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

Intervention Type DRUG

Perampanel 4mg

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Fycompa Fycompa Fycompa

Eligibility Criteria

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Inclusion Criteria

1. Healthy adults between the ages of 18 and 55 years
2. Male or female (using approved birth control methods)
3. Informed consent obtained

Exclusion Criteria

1. Presence of clinically significant cardiovascular, endocrine, hematopoietic, hepatic, neurologic, psychiatric, or renal disease.
2. Presence or history of drug or alcohol abuse or positive urine drug test at screening.
3. The use of concomitant medications, which are known to affect perampanel or the use of any concomitant medications that may alter cognitive function (see Section VIII.F for a partial list).
4. Prior adverse reaction to or prior hypersensitivity to perampanel.
5. Prior participation in studies involving perampanel.
6. Subjects who have received any investigational drug within the previous thirty days.
7. Subjects with IQ \< 80 as determined by the Peabody Picture Vocabulary Test after enrollment.
8. Positive pregnancy test. Women of childbearing potential will be required to use approved birth control methods during the study.
9. Presence of lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the C-SSRS at Screening.
10. Invalid results on computerized cognitive tests at screening as indicated by a 'No' on any of the validity indicators generated in the CNS Vital Signs report.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes