Clinical trial NCT04417907: Perampanel Titration and Cognitive Effects
Official title: Effects of Titration Rate on Cognitive and Behavioral Side Effects of Perampanel
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Epilepsy
Keywords: Perampanel
Cognition
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Eisai Inc.
First posted: 2020-06-05
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall Neuropsychological Composite Z-score as a Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment.
timeFrame: At the end of each week of treatment for 6 weeks.
measure: Composite Z-score of Objective Measures as a Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment.
timeFrame: At the end of each week of treatment for 6 weeks.
measure: Composite Z-score of Subjective Measures as a Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment.
timeFrame: At the end of each week of treatment for 6 weeks.
Secondary outcomes:
measure: Treatment Emergent Adverse Events (TEAEs) Across the Six-week Treatment Period Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment.
timeFrame: At the end of each week of treatment for 6 weeks.
measure: Dropouts Across the Six-week Treatment Period Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment.
timeFrame: At the end of each week of treatment for 6 weeks.
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: New York
country: United States
facility: New York University
state: New York
Study officials:
affiliation: Stanford University
name: Kimford Meador, MD
role: PRINCIPAL_INVESTIGATOR
References: