Status:
COMPLETED
A Study of Istradefylline (KW-6002) in Treating Patients With Parkinson's Disease on Levodopa
Lead Sponsor:
Kyowa Kirin, Inc.
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE3
Brief Summary
To establish the efficacy of 10, 20 and 40 mg/d dose of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa.
Detailed Description
To establish the efficacy of 10, 20 and 40 mg/d dose of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa. Patients who me...
Eligibility Criteria
Inclusion
- UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD.
- PD stages 2-4 in the OFF state for Modified Hoehn and Yahr Scale.
- On levodopa/carbidopa for at least one year, stable dose in past 4 weeks.
- Currently take at least three doses of levodopa/carbidopa per day.
- Predictable end of dose wearing off.
- Able to satisfactorily complete Hauser version of a Parkinson's diary.
- Have an average of 180 minutes of OFF time on two 24 hour diaries.
- Be at least 30 years of age.
Exclusion
- Neurosurgical treatment for PD.
- History of psychosis.
- Diagnosis of atypical parkinsonism, secondary parkinsonism variant or Parkinson's plus syndromes.
- Diagnosis of cancer within 5 years.
- Mini-mental status examination score of 25 or less.
- History of seizures or neurologic malignant\_syndrome.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
580 Patients enrolled
Trial Details
Trial ID
NCT00199420
Start Date
July 1 2004
End Date
December 1 2005
Last Update
April 25 2024
Active Locations (2)
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1
Kyowa Pharmaceutical Inc.
Princeton, New Jersey, United States, 08540
2
Kyowa Pharmaceutical
Princeton, New Jersey, United States, 08540