Parkinson's Disease
Conditions
Keywords
long-term tolerability and safety, istradefylline treatment, levodopa/carbidopa
Brief summary
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.
Interventions
DRUGistradefylline
Sponsors
Kyowa Kirin, Inc.
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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
Countries
United States
Outcome results
None listed