Status:
COMPLETED
12-Week, Double-Blind, Placebo-Controlled Study of 20 and 60 mg/Day Istradefylline in Parkinson's Disease Patients on Levodopa/Carbodopa
Lead Sponsor:
Kyowa Kirin, Inc.
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief Summary
A 12-week, multicenter, double-blind, randomized study designed to evaluate the safety and efficacy of 20 and 60 mg/day istradefylline compared with placebo in subjects with OFF-time phenomena and adv...
Eligibility Criteria
Inclusion
- United Kingdom Parkinson's Disease Society brain bank diagnostic criteria (Steps 1 and 2).
- Modified Hoehn and Yahr in the OFF state of II-IV.
- Treated with levodopa/carbidopa for at least one year with a stable regimen for 4 weeks prior to randomization.
- Taking at least 4 doses of levodopa/carbidopa per day (3 doses if at least 2 doses contained slow-release formulation) with predictable end of dose wearing off.
- Successfully competed Parkinson's disease patient diary training with at least 120 minutes of OFF time per day.
- Stable regimen of other antiparkinson's medications for 4 weeks prior to randomization.
- At least 30 years of age and able to give written informed consent.
Exclusion
- Treatment with liquid levodopa/carbidopa within 4 weeks of randomization.
- Treatment with MAO inhibitors except selegiline.
- Treatment within 3 months with centrally acting dopamine antagonists (6 months for depot formulations), e.g., antipsychotic neuroleptics, metoclopramide, buspirone, amoxapine.
- Neurosurgical operation for Parkinson's disease.
- Atypical parkinsonism or secondary parkinsonism variants.
- Diagnosis of cancer or evidence of continued disease within 5 years.
- 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.
- Clinically relevant depression disorder.
- History of neuroleptic malignant syndrome.
- Pregnancy or lactation. Women of child bearing potential must use a reliable method of contraception.
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
End Date :
October 1 2003
Estimated Enrollment :
325 Patients enrolled
Trial Details
Trial ID
NCT00456794
Start Date
March 1 2002
End Date
October 1 2003
Last Update
April 25 2024
Active Locations (1)
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1
Contact Kyowa Pharmaceutical, Inc.
Princeton, New Jersey, United States, 08540