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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 is a Phase 3 study that has completed, run by UCB Biosciences. The registered enrollment target is 30 participants.

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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.

Interventions

  • DRUG Placebo
  • DRUG Rotigotine

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2012-04
Est. Completion 2013-10
Phase Phase 3

Sponsor

UCB Biosciences

39 total trials

What the Registry Record Tells You About NCT01537042

The ClinicalTrials.gov registry entry for NCT01537042 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UCB Biosciences, which has 39 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01537042 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.