A 12-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study of the Efficacy of Doses of 20 and 60 mg/Day Istradefylline as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa

Kyowa Kirin, Inc.1 site in 1 country325 target enrollmentMarch 2002

ConditionsParkinson's Disease

DrugsIstradefylline (KW-6002)

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Parkinson's Disease
Sponsor: Kyowa Kirin, Inc.
Enrollment: 325
Locations: 1
Primary Endpoint: Change from Baseline to Endpoint in percentage of awake time per day in an OFF state based on the subjects' valid ON/OFF Parkinson's disease diary data.
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 advanced Parkinson's disease treated with levodopa/carbidopa.

Registry

clinicaltrials.gov

Start Date

March 2002

End Date

October 2003

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kyowa Kirin, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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.

Outcomes

Primary Outcomes

Change from Baseline to Endpoint in percentage of awake time per day in an OFF state based on the subjects' valid ON/OFF Parkinson's disease diary data.

Secondary Outcomes

Actual values and mean change from Baseline in percentage and total hours of awake time per day in the OFF state and ON state, UPDRS I-IV, II and III Scores during ON and OFF states, Global Clinical Impression-Improvement (CGI-I), safety