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A Sleep Lab Trial to Investigate the Efficacy and Safety of Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome

This study has been completed.
Information provided by:
UCB Pharma Identifier:
First received: January 10, 2006
Last updated: September 24, 2014
Last verified: September 2009
The objective of this trial is to demonstrate that rotigotine (SPM 936) is effective in subjects with idiopathic RLS based on the PLMI (Periodic Limb Movements Index)(PLMs/total time in bed) as measured by polysomnography (PSG). The primary variable is the reduction of PLMI at the end of the Maintenance Period compared to Baseline. PLMI data will be obtained from PSGs.

Condition Intervention Phase
Restless Legs Syndrome
Drug: Rotigotine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Two-arm, Parallel-group, Sleep Lab Trial to Investigate the Efficacy and Safety of Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome

Resource links provided by NLM:

Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Efficacy is assessed by reduction of Periodic Limb Movement Index, which will be obtained from polysomnographic measurements.

Secondary Outcome Measures:
  • Changes in Periodic Limb Movement Arousal Index, Sleep efficiency, International RLS sum score, Clinical Global Impression Item 1.

Estimated Enrollment: 60
Study Start Date: November 2005
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Idiopathic RLS

Exclusion Criteria:

  • secondary RLS
  • history of sleep disturbances
  • symptomatic orthostatic hypotension
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Please refer to this study by its identifier: NCT00275236

Schwarz BioSciences
Monheim, Germany
Sponsors and Collaborators
UCB Pharma
Study Director: UCB Clinical Trial Call Center UCB Pharma
  More Information

Additional Information:
Publications: Identifier: NCT00275236     History of Changes
Other Study ID Numbers: SP0794
2005-002814-39 ( EudraCT Number )
Study First Received: January 10, 2006
Last Updated: September 24, 2014

Keywords provided by UCB Pharma:
Idiopthic Restless Legs Syndrome

Additional relevant MeSH terms:
Psychomotor Agitation
Restless Legs Syndrome
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Mental Disorders
N 0437
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 25, 2017