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NCT00275236 Clinical Trial

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

Restless Legs Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00275236
Other study ID # SP0794
Secondary ID 2005-002814-39
Status Completed
Phase Phase 3
First received January 10, 2006
Last updated September 24, 2014
Start date November 2005
Est. completion date July 2006

Study information
Verified date September 2009
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date July 2006
Est. primary completion date July 2006
Accepts healthy volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Idiopathic RLS

Exclusion Criteria:

- secondary RLS

- history of sleep disturbances

- symptomatic orthostatic hypotension

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Rotigotine

Locations
Country Name City State
Germany Schwarz BioSciences Monheim

Sponsors (1)
Lead Sponsor Collaborator
UCB Pharma

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 i — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy is assessed by reduction of Periodic Limb Movement Index, which will be obtained from polysomnographic measurements.
Secondary Changes in Periodic Limb Movement Arousal Index, Sleep efficiency, International RLS sum score, Clinical Global Impression Item 1.
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