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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00456586

Enrollment

180

Registered

2007-04-05

Start date

2002-04-30

Completion date

2003-06-30

Last updated

2024-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Parkinson's disease, Levodopa therapy, End of dose wearing off, Off time

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.

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.

Interventions

DRUGKW-6002 (istradefylline)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

Inclusion criteria

1. United Kingdom Parkinson's Disease Society brain bank diagnostic criteria (step 1 and 2). 2. Modified Hoehn and Yahr Scale II-IV in the OFF state. 3. Treated with levodopa/carbidopa for 1 year with a stable regimen for 4 weeks prior to randomization. 4. 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. 5. Successfully completed Parkinson's disease patient diary training with at least 120 minutes of OFF time per day. 6. Stable regimen of other antiparkinson's disease medications for at least 4 weeks prior to randomization. 7. At least 30 years of age and able to give written informed consent.

Exclusion criteria

1. Treatment with liquid levodopa/carbodopa within 4 weeks of randomization. 2. Treatment with MAO inhibitors except selegiline. 3. Treatment with centrally acting dopamine antagonists within 3 months (6 months for depot preparations), e.g., antipsychotic neuroleptics, metoclopramide, buspirone, amoxapine. 4. Neurosurgical surgery for Parkinson's disease. 5. Atypical parkinsonism or secondary parkinsonism variants. 6. 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). 7. Mini-Mental Status Examination score of 25 or less. 8. History of drug or alcohol abuse or dependence within 2 years. 9. History of psychotic illness or seizures. 10. Current clinically relevant depression disorder. 11. History of neuroleptic malignant syndrome. 12. Pregnant or lactating females. Women of child-bearing potential must use reliable method of contraception.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026