NCT03754582

A Study of Intravenous Perampanel in Japanese Participants With Epilepsy

A Multicenter, Uncontrolled, Open-label Study to Evaluate the Safety and Tolerability of Intravenous Perampanel as Substitute for Oral Tablet in Subjects With Partial Onset Seizures (Including Secondarily Generalized Seizures) or Primary Generalized Tonic-clonic Seizures

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the safety and tolerability of perampanel administered as a 30-minute intravenous infusion after switching from oral tablets (8 to 12 milligrams per day \[mg/day\]) as an adjunctive therapy in participants with epilepsy with partial onset seizures (POS) (including secondarily generalized seizures) or primary generalized tonic-clonic (PGTC) seizures.

Conditions

• Epilepsy
• Seizures

Interventions

Type	Name	Description
DRUG	Perampanel	Oral tablets.
DRUG	Perampanel	Intravenous infusion.

Timeline

• Start date: 2018-11-27
• Primary completion: 2019-12-10
• Completion: 2019-12-10
• First posted: 2018-11-27
• Last updated: 2021-01-05
• Results posted: 2021-01-05

Locations

13 sites across 1 country: Japan