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

Sponsor

Kyowa Kirin, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00456586

Collaborator

(none)

180

Enrollment

Location

Duration (Months)

12.9

Patients Per Site Per Month

Study Details

Study Description

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 advanced PD who were treated with levodopa/carbidopa.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Drug: KW-6002 (istradefylline)	Phase 2

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 advanced PD who were treated with levodopa/carbidopa.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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 :

Apr 1, 2002

Actual Primary Completion Date :

May 1, 2003

Actual Study Completion Date :

Jun 1, 2003

Outcome Measures

Primary Outcome Measures

To evaluate the safety and efficacy of 40 mg/day istradefylline for reducing OFF time in subjects with Parkinson's disease (PD) treated with levodopa/carbidopa. []

Secondary Outcome Measures

To establish the efficacy of 40 mg/day istradefylline for reducing motor symptoms and improving activities of daily living (ADL) in subjects with advanced PD treated with levodopa/carbidopa. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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.