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NCT00456586 · ClinicalTrials.gov registry record · Phase 2

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 Phase 2 study, sponsored by Kyowa Kirin.

Completed
Registry status
Phase 2
Development phase
180
Enrollment target

NCT00456586: Completed Phase 2 study, sponsored by Kyowa Kirin.

NCT00456586 is a Phase 2 study that has completed, run by Kyowa Kirin. The registered enrollment target is 180 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00456586, a Phase 2 study, has completed, sponsored by Kyowa Kirin.

COMPLETED
Registry status
Phase 2
Development phase
180 participants
Enrollment target

Study 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.

Interventions

  • DRUG KW-6002 (istradefylline)

Trial Details

FieldValue
Enrollment Target 180 participants
Start Date 2002-04
Est. Completion 2003-06
Phase Phase 2
Kyowa Kirin

34 total trials

What the finished NCT00456586 record still lists

NCT00456586 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher).

The record links to 0 conditions, and to 1 intervention - of which KW-6002 (istradefylline) is the first listed.

NCT00456586 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00456586 about?

NCT00456586 is a clinical study titled "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". 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.

What is the current status of trial NCT00456586?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2002-04. Estimated completion is 2003-06.

What interventions are being tested in trial NCT00456586?

The interventions under investigation include: KW-6002 (istradefylline) (DRUG).

Who is sponsoring clinical trial NCT00456586?

This trial is sponsored by Kyowa Kirin, which has 34 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00456586's enrollment target sits among peer trials

180 365th of 2000 higher than 1,610 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00456586, the US trial registry maintained by the National Library of Medicine. NCT00456586 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.