A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Perampanel (E2007) as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects With Motor Fluctuations
Overview
- Phase
- Phase 3
- Intervention
- Perampanel
- Conditions
- Parkinson's Disease
- Sponsor
- Eisai Limited
- Enrollment
- 328
- Locations
- 1
- Primary Endpoint
- Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
E2007
E2007 2 mg (one 2 mg tablet taken daily in the evening), or 4 mg (two 2 mg tablets daily in the evening).
Intervention: Perampanel
Outcomes
Primary Outcomes
Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study
Time Frame: Baseline, Week 0, Week 2, Week 4, Week 8, Week 20, Follow-up
OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. All data was collected using a 3-day diary within a window of a defined visit.
Secondary Outcomes
- Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study(Baseline, Week 0, Week 20, Week 32)
- Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open-label Extension Study(Baseline, Week 0, Week 20, Week 32)
- Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study(Baseline, Week 0, Week 2, Week 4, Week 8, Week 20, Follow-up)