NCT03288129

Study to Evaluate the Efficacy and Safety of Perampanel as Monotherapy or First Adjunctive Therapy in Subjects With Partial Onset Seizures With or Without Secondarily Generalized Seizures or With Primary Generalized Tonic-Clonic Seizures

Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Perampanel as Monotherapy or First Adjunctive Therapy in Subjects With Partial Onset Seizures With or Without Secondarily Generalized Seizures or With Primary Generalized Tonic-Clonic Seizures

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 4 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the retention rate of perampanel when given as monotherapy or first adjunctive therapy in participants with partial-onset seizures or primary generalized tonic clonic seizures. The study consists of 4 periods: a Screening Period (to start no earlier than 6 weeks before the first dose of study drug), a Titration Period (up to 13 weeks), a Maintenance Period (39 weeks), and a Follow-Up Period (4 weeks).

Conditions

• Partial Onset Seizures
• Secondarily Generalized Seizures
• Primary Generalized Tonic-Clonic Seizures

Interventions

Type	Name	Description
DRUG	Perampanel	film-coated tablets

Timeline

• Start date: 2017-08-23
• Primary completion: 2021-04-27
• Completion: 2021-04-27
• First posted: 2017-09-19
• Last updated: 2022-05-16
• Results posted: 2022-05-16

Locations

24 sites across 1 country: United States

Regulatory

• FDA-regulated drug study