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.
Sponsor:
Information provided by:
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00275236
First received: January 10, 2006
Last updated: September 24, 2014
Last verified: September 2009
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Idiopathic RLS

Exclusion Criteria:

  • secondary RLS
  • history of sleep disturbances
  • symptomatic orthostatic hypotension
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00275236

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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00275236     History of Changes
Other Study ID Numbers: SP0794, 2005-002814-39
Study First Received: January 10, 2006
Last Updated: September 24, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by UCB Pharma:
Idiopthic Restless Legs Syndrome

Additional relevant MeSH terms:
Psychomotor Agitation
Restless Legs Syndrome
Syndrome
Disease
Dyskinesias
Dyssomnias
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Parasomnias
Pathologic Processes
Psychomotor Disorders
Signs and Symptoms
Sleep Disorders
Sleep Disorders, Intrinsic
N 0437
Dopamine Agents
Dopamine Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014