A Long-Term, Safety Study With a Flexible Dose Range of KW-6002 in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy
NCT ID: NCT00955045
Last Updated: 2024-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
INTERVENTIONAL
2002-08-31
2003-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Groups
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istradefylline
istradefylline
Interventions
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istradefylline
Eligibility Criteria
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Inclusion Criteria
* 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
30 Years
ALL
No
Sponsors
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Kyowa Kirin, Inc.
INDUSTRY
Responsible Party
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Locations
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48 Centers in the US and 4 in Canada
Princeton, New Jersey, United States
Countries
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Other Identifiers
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6002-US-007
Identifier Type: -
Identifier Source: org_study_id
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