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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-002814-39 | EudraCT Number |
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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotigotine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy is assessed by reduction of Periodic Limb Movement Index, which will be obtained from polysomnographic measurements. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Periodic Limb Movement Arousal Index, Sleep efficiency, International RLS sum score, Clinical Global Impression Item 1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | UCB Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schwarz BioSciences | Monheim | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20813583 | Result | Oertel WH, Benes H, Garcia-Borreguero D, Hogl B, Poewe W, Montagna P, Ferini-Strambi L, Sixel-Doring 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. |
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| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| C047508 | rotigotine |
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| D020447 |
| Parasomnias |
| D001523 | Mental Disorders |