A Sleep Lab Trial to Investigate the Efficacy and Safety of Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome
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|ClinicalTrials.gov Identifier: NCT00275236|
Recruitment Status : Completed
First Posted : January 11, 2006
Last Update Posted : September 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Restless Legs Syndrome||Drug: Rotigotine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||July 2006|
|Actual Study Completion Date :||July 2006|
- Efficacy is assessed by reduction of Periodic Limb Movement Index, which will be obtained from polysomnographic measurements.
- Changes in Periodic Limb Movement Arousal Index, Sleep efficiency, International RLS sum score, Clinical Global Impression Item 1.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00275236
|Study Director:||UCB Clinical Trial Call Center||UCB Pharma|