drugset / Trial / 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

NCT03288129

Phase 4 Completed 54 enrolled Eisai Inc.
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2017-08-23
Primary completion
2021-04-27
Completion
2021-04-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Perampanel Small molecule 2 mg Oral
Subject Perampanel Small molecule 4 mg Oral
Subject Perampanel Small molecule 6 mg Oral
Subject Perampanel Small molecule 8 mg Oral
Subject Perampanel Small molecule 10 mg Oral
Subject Perampanel Small molecule 12 mg Oral