NCT00456586

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (planned)
• Sponsor: Kyowa Kirin, Inc. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	KW-6002 (istradefylline)

Timeline

• Start date: 2002-04-01
• Primary completion: 2003-05-01
• Completion: 2003-06-01
• First posted: 2007-04-05
• Last updated: 2024-04-25

Locations

1 site across 1 country: United States