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: August 26, 2014
Last verified: September 2009

January 10, 2006
August 26, 2014
November 2005
July 2006   (final data collection date for primary outcome measure)
Efficacy is assessed by reduction of Periodic Limb Movement Index, which will be obtained from polysomnographic measurements.
PLMI
Complete list of historical versions of study NCT00275236 on ClinicalTrials.gov Archive Site
Changes in Periodic Limb Movement Arousal Index, Sleep efficiency, International RLS sum score, Clinical Global Impression Item 1.
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A Sleep Lab Trial to Investigate the Efficacy and Safety of Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome
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

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.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Restless Legs Syndrome
Drug: Rotigotine
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Oertel WH, Benes H, Garcia-Borreguero D, Högl B, Poewe W, Montagna P, Ferini-Strambi L, Sixel-Döring F, Trenkwalder C, Partinen M, Saletu B, Polo O, Fichtner A, Schollmayer E, Kohnen R, Cassel W, Penzel T, Stiasny-Kolster K. Rotigotine transdermal patch in moderate to severe idiopathic restless legs syndrome: a randomized, placebo-controlled polysomnographic study. Sleep Med. 2010 Oct;11(9):848-56. doi: 10.1016/j.sleep.2010.02.014. Epub 2010 Sep 1. PubMed PMID: 20813583.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
July 2006
July 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Idiopathic RLS

Exclusion Criteria:

  • secondary RLS
  • history of sleep disturbances
  • symptomatic orthostatic hypotension
Both
18 Years to 75 Years
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Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00275236
SP794, 2005-002814-39
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UCB Pharma
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Study Director: UCB Clinical Trial Call Center UCB Pharma
UCB Pharma
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP