Who is sponsoring NCT00456794?

NCT00456794 is sponsored by Kyowa Kirin, Inc..

What condition does NCT00456794 study?

NCT00456794 studies Parkinson's Disease.

What drugs are being tested in NCT00456794?

Interventions: Istradefylline (KW-6002).

What is the status of NCT00456794?

NCT00456794 is currently COMPLETED.

Last reviewed 2024-04-23 · How we verify

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

NCT00456794 Phase 2 COMPLETED

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.

Details

Lead sponsor	Kyowa Kirin, Inc.
Phase	Phase 2
Status	COMPLETED
Enrolment	325
Start date	2002-03
Completion	2003-10

Conditions

Parkinson's Disease

Interventions

Istradefylline (KW-6002)

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.

Countries

United States