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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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 Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Polysomnography Study to Investigate Safety and Efficacy of the Rotigotine Transdermal Patch in Subjects With Restless Legs Syndrome and End-Stage Renal Disease Requiring Hemodialysis

NCT01537042•UCB BIOSCIENCES GmbH

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•End-Stage Renal Disease (ESRD) requiring hemodialysis and regular dialysis schedule
•Fulfillment of pre-defined criteria of hematology parameters
•Diagnosis of Restless Legs (RLS) based on the 4 cardinal diagnostic clinical features according to the International Restless Legs Syndrome Study Group
•Initial response to previous dopaminergic treatment for RLS, or has had no previous dopaminergic treatment (ie, de novo)
•Score of ≥ 15 points on the IRLS (indicating moderate to severe RLS) at Baseline
•Score of ≥ 11 points on the RLS-DI (Diagnostic Index) at Baseline
•Score of ≥ 4 points on the Clinical Global Impressions (CGI) Item 1 assessment (indicating moderately ill) at Baseline
•Scores ≥ 15 Periodic Limb Movements (PLMs) per hour on the Periodic Limb Movement Index (PLMI) based on Polysomnography (PSG) (recorded during the second night) as assessed by the investigator at Baseline

Exclusion Criteria

•Clinically relevant Polyneuropathy or Varicosis which cannot be clearly differentiated from RLS symptoms in the opinion of the investigator
•Clinically relevant concomitant diseases, such as Attention Deficit Hyperactivity Disorder, Painful Legs, and Moving Toes
•Other central nervous system diseases
•Evidence of an impulse control disorder according to the modified Minnesota Impulsive Disorders Interview (mMIDI)
•Lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('yes') to either Question 4 or Question 5 of the Columbia-Suicidality Severity Rating Scale (C-SSRS) at Screening (Visit 1) or Baseline (Visit 2)
•Prior history of psychotic episodes
•History of symptomatic (not asymptomatic) Orthostatic Hypotension
•Clinically relevant Cardiovascular Disease
•Clinically relevant Venous or Arterial Peripheral Vascular Disease
•Malignant Neoplastic Disease requiring therapy within 12 months prior to Screening (Visit 1)
+6 more criteria

Locations (15)

606

Brandon, Florida, United States

604

Newton, Massachusetts, United States

603

West Seneca, New York, United States

607

Dublin, Ohio, United States

605

West Chester, Pennsylvania, United States

601

Austin, Texas, United States

101

Innsbruck, Austria

201

Helsinki, Finland

203

Tampere, Finland

302

Bordeaux, France

Key Dates

Start Date

April 1, 2012

Primary Completion Date

October 1, 2013

Completion Date

October 1, 2013

Last Updated

November 3, 2014

Enrollment

ACTUAL participants

Conditions

Restless Legs SyndromeEnd-Stage Renal Disease

Interventions

Rotigotine

DRUG

Placebo

DRUG

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Kidney Disease, End-StageEnd-stage Renal Disease+1 more

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RECRUITINGPHASE3

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HyperphosphatemiaChronic Kidney Disease, Receiving Dialysis+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 3, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System

A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China

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