At a glance
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A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaluate the Efficacy of Oral Istradefylline 20 and 40 mg/Day as Treatment for Subjects With Moderate to Severe Parkinson's Disease
In Brief
A Phase 3 clinical trial evaluating Istradefylline 40 mg, Istradefylline 20 mg, and 1 other intervention for Idiopathic Parkinson's Disease. Completed, enrolled 613 participants across 89 sites in 8 countries.
Detailed Summary
This is a study to assess the efficacy and safety of oral Istradefylline (KW-6002) in patients with moderate to severe Parkinson's Disease. While on this study, participants will continue to take their usual, prescribed, stable regimen of Levodopa/Carbidopa or Levodopa/Benserazide therapy plus adjunct Parkinson's medications. Patients will be randomized 1:1:1 to receive either Istradefylline 20 mg per day, or Istradefylline 40 mg per day or an equivalent placebo. Patients will be treated for a 12 week period to demonstrate the effectiveness of Istradefylline in improving Parkinson's disease symptoms (referred to as improvement in patient OFF time) and that Istradefylline has an acceptable safety profile in this group.
Study Details
Timeline
Interventions
Istradefylline 40 mg and placebo
Istradefylline 20 mg and placebo
Placebo