A Long-Term, Safety Study With a Flexible Dose Range of KW-6002 in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy
A Long-Term, Safety Study With a Flexible Dose Range of KW-6002 in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy
The primary objective of this study was to establish the long-term tolerability and safety of
 istradefylline treatment in subjects with Parkinson's disease treated with
 levodopa/carbidopa. In addition, treatment response and maintenance of response were
 assessed.
Inclusion Criteria:

 Eligible subjects were:

 -  male or female

 -  at least 30 years of age

 -  had completed participation in a prior double-blind istradefylline trial

 -  met United Kingdom's Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1
 and Step 2) for Parkinson's disease and the severity of the Parkinson's disease was
 defined as Stages 2-4 on the Modified Hoehn and Yahr Scale while in the OFF state

 -  had been treated with levodopa for at least 1 year

 -  had been on a stable Parkinson's disease regimen within normal therapeutic ranges
 including levodopa for at least 4 weeks before Baseline

 -  were currently taking at least 4 doses of levodopa per day (3 doses per day if at
 least 2 doses contained slow-release formulation)

 -  had predictable end-of-dose wearing-off

 Exclusion Criteria:

 -  none