Perampanel Titration and Cognitive Effects

Kimford Jay Meador

Status and phase: Terminated; Phase 4

Conditions: Epilepsy

Treatments: Drug: Perampanel 1 week titration; Drug: Placebo; Drug: Perampanel 4mg; Drug: Perampanel 2 week titration

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04417907

54358

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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29 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

PER 1 Week Titration

Experimental group

Description:

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

Treatment:

Drug: Perampanel 1 week titration

PER 2 Week Titration

Experimental group

Description:

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

Treatment:

Drug: Perampanel 2 week titration

PER 4 mg

Experimental group

Description:

Participants will take 4mg perampanel PO QD for six weeks

Treatment:

Drug: Perampanel 4mg