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NCT00199446 · ClinicalTrials.gov registry record · Phase 2
Study of Istradefylline (KW-6002) for the Treatment of Restless Legs Syndrome
A Phase 2 study, sponsored by Kyowa Kirin.
- Completed
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
NCT00199446: Completed Phase 2 study, sponsored by Kyowa Kirin.
NCT00199446 is a Phase 2 study that has completed, run by Kyowa Kirin. The registered enrollment target is 160 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00199446, a Phase 2 study, has completed, sponsored by Kyowa Kirin.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
Study Summary
The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of 40 mg per day of istradefylline (KW6002) in patients with Restless Legs Syndrome.
Interventions
- DRUG Istradefylline (KW-6002)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2005-07 |
| Est. Completion | 2006-10 |
| Phase | Phase 2 |
What the finished NCT00199446 record still lists
NCT00199446 is an interventional study that assigns participants to a tested intervention. The registered 160 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 (20% higher).
The record links to 0 conditions, and to 1 intervention - of which Istradefylline (KW-6002) is the first listed.
NCT00199446 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00199446 about?
NCT00199446 is a clinical study titled "Study of Istradefylline (KW-6002) for the Treatment of Restless Legs Syndrome". The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of 40 mg per day of istradefylline (KW6002) in patients with Restless Legs Syndrome.
What is the current status of trial NCT00199446?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2005-07. Estimated completion is 2006-10.
What interventions are being tested in trial NCT00199446?
The interventions under investigation include: Istradefylline (KW-6002) (DRUG).
Who is sponsoring clinical trial NCT00199446?
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 NCT00199446's enrollment target sits among peer trials
160 422nd of 2000 higher than 1,559 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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