A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease
Status:
Completed
Trial end date:
2016-10-01
Target enrollment:
Participant gender:
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.