A Study of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations
Status:
Terminated
Trial end date:
2008-04-01
Target enrollment:
Participant gender:
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withdrawn from the study.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.