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NCT01537042 · ClinicalTrials.gov registry record · Phase 3
A Sleep Laboratory Study to Investigate the Safety and Efficacy of the Rotigotine Skin Patch in Subjects With Restless Legs Syndrome and End-Stage Renal Disease Requiring Hemodialysis
A Phase 3 study, sponsored by UCB Biosciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 30
- Enrollment target
NCT01537042: Completed Phase 3 study, sponsored by UCB Biosciences.
NCT01537042 is a Phase 3 study that has completed, run by UCB Biosciences. The registered enrollment target is 30 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01537042, a Phase 3 study, has completed, sponsored by UCB Biosciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is a sleep laboratory study to evaluate the efficacy and safety of Rotigotine in subjects with Restless Legs Syndrome and End-Stage Renal Disease requiring hemodialysis. The objectives are to demonstrate superiority of Rotigotine against Placebo as well as to investigate the effect of Rotigotine on quality of life and sleep.
Primary Outcome
The PLMI is defined as Periodic Limb Movements (PLMs)/ total time in bed in hours. PLMs are measured by Polysomnography (PSG). The reduction of the PLMI is reflected in terms of the ratio from Baseline to the end of the Maintenance Period and was calculated as \[PLMI at end of Maintenance Period (MP)\] / \[PLMI at Baseline\]. A PLMI Ratio \<1 indicates an improvement from Baseline to the end of the 2-week MP.
Interventions
- DRUG Placebo
- DRUG Rotigotine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-04 |
| Est. Completion | 2013-10 |
| Phase | Phase 3 |
What the finished NCT01537042 record still lists
NCT01537042 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01537042 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01537042 about?
NCT01537042 is a clinical study titled "A Sleep Laboratory Study to Investigate the Safety and Efficacy of the Rotigotine Skin Patch in Subjects With Restless Legs Syndrome and End-Stage Renal Disease Requiring Hemodialysis". This is a sleep laboratory study to evaluate the efficacy and safety of Rotigotine in subjects with Restless Legs Syndrome and End-Stage Renal Disease requiring hemodialysis. The objectives are to demonstrate superiority of Rotigotine against Placebo as well as to investigate the effect of Rotigoti...
What is the current status of trial NCT01537042?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2012-04. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01537042?
The interventions under investigation include: Placebo (DRUG), Rotigotine (DRUG).
Who is sponsoring clinical trial NCT01537042?
This trial is sponsored by UCB Biosciences, which has 39 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01537042's enrollment target sits among peer trials
30 1917th of 2000 higher than 68 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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