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NCT00199368 · ClinicalTrials.gov registry record · Phase 3

An Extension of Istradefylline in Parkinson's Disease Patients Who Have Completed Studies 6002-EU-007, 6002-US-013 or 6002-US-018

A Phase 3 study, sponsored by Kyowa Kirin.

Completed
Registry status
Phase 3
Development phase
1,100
Enrollment target

NCT00199368: Completed Phase 3 study, sponsored by Kyowa Kirin.

NCT00199368 is a Phase 3 study that has completed, run by Kyowa Kirin. The registered enrollment target is 1,100 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00199368, a Phase 3 study, has completed, sponsored by Kyowa Kirin.

COMPLETED
Registry status
Phase 3
Development phase
1,100 participants
Enrollment target

Study Summary

This is a 1-year, open-label, long-term safety extension for patients who have completed prior istradefylline studies 6002-EU-007, 6002-US-013 or 6002-US-018.

Interventions

  • DRUG Istradefylline ( KW-6002)

Trial Details

FieldValue
Enrollment Target 1,100 participants
Start Date 2004-10
Est. Completion 2007-05
Phase Phase 3
Kyowa Kirin

34 total trials

What the finished NCT00199368 record still lists

NCT00199368 is an interventional study that assigns participants to a tested intervention. Its 1,100 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% higher).

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

NCT00199368 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00199368 about?

NCT00199368 is a clinical study titled "An Extension of Istradefylline in Parkinson's Disease Patients Who Have Completed Studies 6002-EU-007, 6002-US-013 or 6002-US-018". This is a 1-year, open-label, long-term safety extension for patients who have completed prior istradefylline studies 6002-EU-007, 6002-US-013 or 6002-US-018.

What is the current status of trial NCT00199368?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,100 participants. The study started on 2004-10. Estimated completion is 2007-05.

What interventions are being tested in trial NCT00199368?

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

Who is sponsoring clinical trial NCT00199368?

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 NCT00199368's enrollment target sits among peer trials

1,100 252nd of 2000 higher than 1,736 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00199368, the US trial registry maintained by the National Library of Medicine. NCT00199368 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.