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
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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 advanced PD who were treated with levodopa/carbidopa.
Condition or disease
Drug: KW-6002 (istradefylline)
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 advanced PD who were treated with levodopa/carbidopa.
A 12-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study of the Efficacy of 40 mg/Day KW-6002 as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
Resource links provided by the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
30 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.