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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
328
Centre d'Investigation Clinique, Hospital Purpan
Toulouse, Toulouse Cedex, France
Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study
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.
Time frame: Baseline, Week 0, Week 2, Week 4, Week 8, Week 20, Follow-up
Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study
Unified Parkinson's Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson's Disease. Part II assesses activities of daily living (ADL) based on 13 items, such as speech, hygiene, and falling. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.
Time frame: 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
Unified Parkinson's Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson's Disease. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. ON state is when medication is providing benefits to stiffness, slowness, and tremor.
Time frame: 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
ON state is when medication is 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.
Time frame: Baseline, Week 0, Week 2, Week 4, Week 8, Week 20, Follow-up
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