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NCT00806026 · ClinicalTrials.gov registry record · Phase 3
Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients
A Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Completed
- Registry status
- Phase 3
- Development phase
- 731
- Enrollment target
NCT00806026: Completed Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
NCT00806026 is a Phase 3 study that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 731 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00806026, a Phase 3 study, has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 731 participants
- Enrollment target
Study Summary
This purpose of this study is to investigate the efficacy and tolerability of pregabalin in treating idiopathic RLS patients for up to 12 months.
Primary Outcome
International Restless Legs Syndrome Study Group Rating Scale (IRLS) is psychometrically and clinically valid and reliable clinician-administered instrument used to assess the severity of RLS. It assesses RLS symptom severity and impact on daily living and is comprised of 10 items, scored on 0 to 4 scale, where lower score indicates lower symptom severity/impact on living. Two subscale scores are symptom severity (6 items) ranging from 0-24 (lower score indicates lower symptom severity) and impa
Interventions
- DRUG Pregabalin
- DRUG placebo and pregabalin
- DRUG pramipexol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 731 participants |
| Start Date | 2008-12 |
| Est. Completion | 2011-05 |
| Phase | Phase 3 |
What the finished NCT00806026 record still lists
NCT00806026 is an interventional study that assigns participants to a tested intervention. The registered 731 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Pregabalin is the first listed.
NCT00806026 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00806026 about?
NCT00806026 is a clinical study titled "Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients". This purpose of this study is to investigate the efficacy and tolerability of pregabalin in treating idiopathic RLS patients for up to 12 months.
What is the current status of trial NCT00806026?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 731 participants. The study started on 2008-12. Estimated completion is 2011-05.
What interventions are being tested in trial NCT00806026?
The interventions under investigation include: Pregabalin (DRUG), placebo and pregabalin (DRUG), pramipexol (DRUG).
Who is sponsoring clinical trial NCT00806026?
This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00806026's enrollment target sits among peer trials
731 488th of 2000 higher than 1,512 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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