Status:
COMPLETED
12-Week, Double-Blind, Placebo-Controlled, Randomized Study of the Efficacy of 40 mg/Day KW-6002 in Parkinson's Disease Patients on Levodopa/Carbidopa
Lead Sponsor:
Kyowa Kirin, Inc.
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief Summary
12-week, double-blind, placebo-controlled, multicenter, randomized study designed to evaluate the safety and efficacy of 40 mg/day istradefylline compared with placebo in subjects with OFF phenomena a...
Detailed Description
A 12-week, double-blind, placebo-controlled, multicenter, randomized study designed to evaluate the safety and efficacy of 40 mg/day istradefylline compared with placebo in subjects with OFF phenomena...
Eligibility Criteria
Inclusion
- United Kingdom Parkinson's Disease Society brain bank diagnostic criteria (step 1 and 2).
- Modified Hoehn and Yahr Scale II-IV in the OFF state.
- Treated with levodopa/carbidopa for 1 year with a stable regimen for 4 weeks prior to randomization.
- Taking at least 4 doses of levodopa (3 doses if at least 2 doses containing slow release formulation) per day with predictable end of dose wearing off.
- Successfully completed Parkinson's disease patient diary training with at least 120 minutes of OFF time per day.
- Stable regimen of other antiparkinson's disease medications for at least 4 weeks prior to randomization.
- At least 30 years of age and able to give written informed consent.
Exclusion
- Treatment with liquid levodopa/carbodopa within 4 weeks of randomization.
- Treatment with MAO inhibitors except selegiline.
- Treatment with centrally acting dopamine antagonists within 3 months (6 months for depot preparations), e.g., antipsychotic neuroleptics, metoclopramide, buspirone, amoxapine.
- Neurosurgical surgery for Parkinson's disease.
- Atypical parkinsonism or secondary parkinsonism variants.
- Diagnosis of cancer or evidence of continued cancer within 5 years of enrollment or clinically significant illness of any organ system (e.g., ALT or AST \> 1.5 times the upper limit of normal).
- Mini-Mental Status Examination score of 25 or less.
- History of drug or alcohol abuse or dependence within 2 years.
- History of psychotic illness or seizures.
- Current clinically relevant depression disorder.
- History of neuroleptic malignant syndrome.
- Pregnant or lactating females. Women of child-bearing potential must use reliable method of contraception.
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
End Date :
June 1 2003
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00456586
Start Date
April 1 2002
End Date
June 1 2003
Last Update
April 25 2024
Active Locations (1)
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1
Contact Kyowa Pharmacuetical Inc.
Princeton, New Jersey, United States, 08540