Conditions: Parkinson's Disease
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 997
Healthy volunteers: no

Brief summary:
Patients who have completed one of the core trials (E2007-E044-301 or E2007-A001-302) and who meet inclusion/exclusion criteria will be enrolled and will enter the Titration Phase, lasting 4 weeks (weeks 0-3) followed by the Maintenance Phase, lasting 52 weeks (weeks 4-56). All patients will receive active study drug. During the Titration Phase, patients will receive E2007 2 mg once daily (o.d.) for 2 weeks followed by 4 mg o.d. for 2 weeks. During the Maintenance Phase, patients will receive 4 mg o.d. Patients not tolerating the study drug at 4 mg, will be allowed to down titrate to 2 mg. Patients not tolerating 2 mg will be withdrawn from the study.

Patients will have visits at 2, 4, 8, 20, 32, 44, and 56 weeks after study entry. In addition, a follow-up visit will occur 4 weeks after study treatment has ended (week 60).

A home diary will be completed in which patients rate themselves as either:

1. OFF
2. ON without dyskinesia
3. ON with non-troublesome dyskinesias
4. ON with troublesome dyskinesias
5. Asleep

These entries will be completed every half hour during the waking day and will be completed for 3 consecutive days following the visits at weeks 4, 8, 20, 32 and 44, and three days prior to the visits at weeks 56 and 60. At entry into the study (week 0) and at weeks 8, 20, 32, 44 and 56, the Unified Parkinson's Disease Rating Scale (UPDRS), Clinician's Global Impression of Change (CGIC) and Clinical Global Impression of Tolerance (CGIT) will be performed.

Detailed description:

Arms:
arm 1: During the first two weeks of the study, Patients received 1 x 2mg E2007 tablet. At the week 2 visit, patients who tolerated the 2 mg/day dose were up-titrated to receive 4mg/day (2 x 2 mg E2007 tablets). Patients not tolerating the 4 mg dose were allowed to down titrate to 2 mg. Patients who did not tolerate the 2 mg dose were withdrawn from the study. Patients returned at week 4, if their tolerance to the 4 mg/day dose was acceptable they remained on this dose for the maintenance phase of the study. If at any time their tolerance declined, they were to return for an unscheduled visit and the daily dose was reduced to 2 mg. If at any stage, 2 mg day wass not tolerated, the patient was withdrawn from the study.

Interventions: intervention 1: E2007
Intervention descriptions: intervention 1: None

Protocol document: