drugset / Trial / NCT00456794

12-Week, Double-Blind, Placebo-Controlled Study of 20 and 60 mg/Day Istradefylline in Parkinson's Disease Patients on Levodopa/Carbodopa

NCT00456794

Phase 2 Completed 325 enrolled Kyowa Kirin, Inc.
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2002-03
Primary completion
2003-10
Completion
2003-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Istradefylline Small molecule 20 mg
Subject Istradefylline Small molecule 60 mg

Indications