A Long-Term, Safety Study With a Flexible Dose Range of KW-6002 in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy
- Registration Number
- NCT00955045
- Lead Sponsor
- Kyowa Kirin, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description istradefylline istradefylline -
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
48 Centers in the US and 4 in Canada
🇺🇸Princeton, New Jersey, United States