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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 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 640-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (49% lower). The trial reports 1 study location across 1 state.

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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

Sponsor

Kyowa Kirin

34 total trials

What the Registry Record Tells You About NCT00456794

The ClinicalTrials.gov registry entry for NCT00456794 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 325 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 640-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (49% lower). The listed sponsor is Kyowa Kirin, which has 34 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.