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NCT00456794 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Parkinson's Disease, sponsored by Kyowa Kirin.

Completed
Registry status
Phase 2
Development phase
325
Enrollment target
1
Study location

NCT00456794: Completed Phase 2 study of Parkinson's Disease, sponsored by Kyowa Kirin.

NCT00456794 is a Phase 2 study of Parkinson's Disease that has completed, run by Kyowa Kirin. The registered enrollment target is 325 participants, below the 633-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (49% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00456794, a Phase 2 study of Parkinson's Disease, has completed, sponsored by Kyowa Kirin.

COMPLETED
Registry status
Phase 2
Development phase
325 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Interventions

  • DRUG Istradefylline (KW-6002)

Study Locations (1)

New Jersey

  • Contact Kyowa Pharmaceutical, Inc. - Princeton

Trial Details

FieldValue
Enrollment Target 325 participants
Start Date 2002-03
Est. Completion 2003-10
Phase Phase 2
Kyowa Kirin

34 total trials

What the finished NCT00456794 record still lists

NCT00456794 is an interventional study that assigns participants to a tested intervention. The registered 325 participants enrollment target is mid-sized for trials with a published cap, below the 633-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (49% lower).

The record links to 1 condition, with Parkinson's Disease appearing as the primary indexed condition, and to 1 intervention - of which Istradefylline (KW-6002) is the first listed.

NCT00456794 reports a single indexed study location in New Jersey.

Frequently Asked Questions

What is clinical trial NCT00456794 about?

NCT00456794 is a clinical study titled "12-Week, Double-Blind, Placebo-Controlled Study of 20 and 60 mg/Day Istradefylline in Parkinson's Disease Patients on Levodopa/Carbodopa". 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.

What is the current status of trial NCT00456794?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 325 participants. The study started on 2002-03. Estimated completion is 2003-10.

What conditions does trial NCT00456794 study?

This clinical trial studies the following conditions: Parkinson's Disease.

What interventions are being tested in trial NCT00456794?

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

Who is sponsoring clinical trial NCT00456794?

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

Where is trial NCT00456794 being conducted?

This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Parkinson's Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00456794's enrollment target sits among peer trials

325 24th of 158 higher than 135 of 158 other Parkinson's Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Parkinson's Disease 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 NCT00456794, the US trial registry maintained by the National Library of Medicine. NCT00456794 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.