12-Week, Double-Blind, Placebo-Controlled Study of 20 and 60 mg/Day Istradefylline in Parkinson's Disease Patients on Levodopa/Carbodopa

Completed · Phase 2

Conditions studied: Parkinson's Disease

In brief

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 advanced Parkinson's disease treated with levodopa/carbidopa.

Key facts

Study ID

NCT00456794

Run by

Kyowa Kirin, Inc.

People needed

325

Starts

2002-03-01

Expected to finish

2003-10-01

Last updated by the study team

2024-04-25

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Contact Kyowa Pharmaceutical, Inc. — Princeton, New Jersey, United States

Full record on ClinicalTrials.gov

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