drugset / Trial / NCT00505622

Evaluation of the Long-term Safety, Tolerability, and Efficacy of Perampanel (E2007) as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects With Motor Fluctuations

NCT00505622 ↗

Phase 3 Terminated 328 enrolled Eisai Inc.
NaSingle-groupOpen-labelTreatment

Summary

This is a multicentre, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of Perampanel (E2007) as an adjunctive therapy in levodopa treated PD subjects with motor fluctuations. All subjects who have completed E2007-E044-213 or E2007-G000-309 will be candidates for entering this extension trial, provided that they meet the inclusion/exclusion criteria and have completed the core study, up to and including the final efficacy visit.

Timeline

Start
2007-07
Primary completion
2008-04
Completion
2008-04

Outcome

Outcome not reported

Stopped: “Study stopped due to lack of efficacy.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Perampanel Small molecule 2 mg —
Subject Perampanel Small molecule 4 mg —

Indications