Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00135993 · ClinicalTrials.gov registry record · Phase 3
Four Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome
A Phase 3 study, sponsored by UCB Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 811
- Enrollment target
NCT00135993: Completed Phase 3 study, sponsored by UCB Pharma.
NCT00135993 is a Phase 3 study that has completed, run by UCB Pharma. The registered enrollment target is 811 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
NCT00135993, a Phase 3 study, has completed, sponsored by UCB Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 811 participants
- Enrollment target
Study Summary
Subjects who meet the diagnosis of idiopathic restless legs syndrome (RLS) based on the 4 cardinal clinical features according to the International Restless Legs Syndrome Study Group (IRLSSG) are allowed to enroll in this trial. The primary objective of this trial is to demonstrate that rotigotine (SPM 936) is efficacious in subjects with idiopathic restless legs syndrome. Additional objectives are to investigate the safety and tolerability of rotigotine. Subjects will be randomized to receive either placebo, 1.125, 2.25, 4.5, or 6.75mg/day rotigotine in a 1:1:1:1:1 (active:placebo) fashion. Approximately 600 subjects will be enrolled in this trial, participating at approximately 60 sites. The maximum duration of the trial is approximately 8 months (consisting of a 4-week Titration Period, a 6-month Maintenance Period, a 7-day Taper Period, and a 30-day Safety Follow-Up Period).
Interventions
- DRUG Rotigotine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 811 participants |
| Start Date | 2005-05 |
| Est. Completion | 2006-11 |
| Phase | Phase 3 |
What the finished NCT00135993 record still lists
NCT00135993 is an interventional study that assigns participants to a tested intervention. The registered 811 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 1 intervention - of which Rotigotine is the first listed.
NCT00135993 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00135993 about?
NCT00135993 is a clinical study titled "Four Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome". Subjects who meet the diagnosis of idiopathic restless legs syndrome (RLS) based on the 4 cardinal clinical features according to the International Restless Legs Syndrome Study Group (IRLSSG) are allowed to enroll in this trial. The primary objective of this trial is to demonstrate that rotigotine ...
What is the current status of trial NCT00135993?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 811 participants. The study started on 2005-05. Estimated completion is 2006-11.
What interventions are being tested in trial NCT00135993?
The interventions under investigation include: Rotigotine (DRUG).
Who is sponsoring clinical trial NCT00135993?
This trial is sponsored by UCB Pharma, which has 100 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00135993's enrollment target sits among peer trials
811 408th of 2000 higher than 1,592 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05519085 · 810 participants · Phase 3
A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
- NCT06529094 · 808 participants · NA
Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic
- NCT07218029 · 815 participants · Phase 3
A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)
- NCT04613596 · 806 participants · Phase 2
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia