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NCT00199381 · ClinicalTrials.gov registry record · Phase 3
An Extension of Istradefylline in North American Parkinson's Disease Patients Who Have Completed Study 6002-INT-001
A Phase 3 study, sponsored by Kyowa Kirin.
- Terminated
- Registry status
- Phase 3
- Development phase
- 504
- Enrollment target
NCT00199381: Clinical Trial Phase 3 study, sponsored by Kyowa Kirin.
NCT00199381 is a Phase 3 study that was terminated before completion, run by Kyowa Kirin. The registered enrollment target is 504 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00199381, a Phase 3 study, was terminated before completion, sponsored by Kyowa Kirin.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 504 participants
- Enrollment target
Study Summary
This is an, open-label, long-term safety extension for patients in North America who have completed the prior istradefylline study 6002-INT-001.
Primary Outcome
Investigation of the long-term tolerability and safety of istradefylline
Interventions
- DRUG Istradefylline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 504 participants |
| Start Date | 2005-10 |
| Est. Completion | 2008-10 |
| Phase | Phase 3 |
Why NCT00199381 stopped before completion
NCT00199381 is an interventional study that assigns participants to a tested intervention. The registered 504 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 1 intervention - of which Istradefylline is the first listed.
NCT00199381 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00199381 about?
NCT00199381 is a clinical study titled "An Extension of Istradefylline in North American Parkinson's Disease Patients Who Have Completed Study 6002-INT-001". This is an, open-label, long-term safety extension for patients in North America who have completed the prior istradefylline study 6002-INT-001.
What is the current status of trial NCT00199381?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 504 participants. The study started on 2005-10. Estimated completion is 2008-10.
What interventions are being tested in trial NCT00199381?
The interventions under investigation include: Istradefylline (DRUG).
Who is sponsoring clinical trial NCT00199381?
This trial is sponsored by Kyowa Kirin, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00199381's enrollment target sits among peer trials
504 742nd of 2000 higher than 1,258 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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