Long Term Study of Istradefylline in Subjects With Moderate to Severe Parkinson's Disease
Status:
Completed
Trial end date:
2017-12-20
Target enrollment:
Participant gender:
Summary
This is a Phase 3, 52-week, open-label, flexible-dose, multinational, multicenter study to
evaluate the safety and tolerability of istradefylline 20 or 40 mg/d in subjects with
moderate to severe PD with motor fluctuations and dyskinesia on levodopa combination
(levodopa/carbidopa or levodopa/benserazide) therapy plus at least one adjunctive PD
medication. Subjects who completed 12 weeks of double-blind treatment and the 30-day
follow-up period in Study No. 6002-014 will undergo Screening and Baseline evaluations for
eligibility for the study. Eligible subjects will be treated with istradefylline at a
starting dose of 20 mg/d with an option for a dose adjustment to 40 mg/d at Week 12 based on
the Investigator's judgment of each subject's response and tolerability. If deemed necessary,
one unscheduled dose adjustment visit between Week 2 to Week 12 is allowed in accordance with
clinical judgment of the Investigator. Subjects who had a dose adjustment to 40 mg/d can have
their dose decreased to 20 mg/d by the Investigator at a second unscheduled dose adjustment
visit if there are tolerability issues. The istradefylline dose should remain fixed between
Week 26 to Week 52. Consultation with the Sponsor's Medical Monitor is required prior to any
unscheduled dose adjustment visits. A subject may discontinue from the study at any time.