NCT04417907

Perampanel Titration and Cognitive Effects

Effects of Titration Rate on Cognitive and Behavioral Side Effects of Perampanel

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Kimford Jay Meador · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Epilepsy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-10-20
• Primary completion: 2023-05-01
• Completion: 2023-05-01
• First posted: 2020-06-05
• Last updated: 2024-06-06
• Results posted: 2024-06-06

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study