Status:
COMPLETED
A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa
Lead Sponsor:
Kyowa Kirin, Inc.
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE3
Brief Summary
To establish the efficacy of a 20 mg/day 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 a 20 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 meet entry ...
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.
- Clinical depression.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT00199407
Start Date
June 1 2004
End Date
January 1 2006
Last Update
April 25 2024
Active Locations (1)
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1
Kyowa Pharmaceutical Inc.
Princeton, New Jersey, United States, 08540