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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011107-23 | EudraCT Number |
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The primary objective for the 12-week Titration-/Maintenance Period is:
To demonstrate superior efficacy of OXN PR compared to PLA in the improvement of symptom severity of RLS.
A randomised, double-blind, placebo-controlled, parallel-group, multicenter study to demonstrate improvement of symptoms of RLS in subjects with moderate to severe idiopathic RLS with daytime symptoms who take oxycodone/naloxone prolonged release (OXN PR) compared to subjects taking placebo (PLA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OXN PR | Experimental | Different daily doses; intake every 12 hours |
|
| PLA | Placebo Comparator | Different daily doses; intake every 12 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone naloxone prolonged release tablets (OXN PR) | Drug | Different daily doses; intake every 12 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the IRLS score between the two treatment arms will be compared | The primary objective for the 12-week Titration-/Maintenance Period is: IRLS: International Restless Legs Syndrome Study Group Rating Scale Assessment Period baseline (visit 3) to final Maintenance Period. | 12 weeks and a 6 month extension |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paracelsus Elena Klinik | Kassel | Germany | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27401882 | Derived | Oertel WH, Hallstrom Y, Saletu-Zyhlarz GM, Hopp M, Bosse B, Trenkwalder C; RELOXYN Study Group. Sleep and Quality of Life Under Prolonged Release Oxycodone/Naloxone for Severe Restless Legs Syndrome: An Analysis of Secondary Efficacy Variables of a Double-Blind, Randomized, Placebo-Controlled Study with an Open-Label Extension. CNS Drugs. 2016 Aug;30(8):749-60. doi: 10.1007/s40263-016-0372-1. | |
| 24140442 |
| Label | URL |
|---|---|
| Results available on website | View source |
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| Placebo (PLA) | Other | Different daily doses; intake every 12 hours |
|
| Barcelona |
| Spain |
| Gothenburg | Sweden |
| Derived |
| Trenkwalder C, Benes H, Grote L, Garcia-Borreguero D, Hogl B, Hopp M, Bosse B, Oksche A, Reimer K, Winkelmann J, Allen RP, Kohnen R; RELOXYN Study Group. Prolonged release oxycodone-naloxone for treatment of severe restless legs syndrome after failure of previous treatment: a double-blind, randomised, placebo-controlled trial with an open-label extension. Lancet Neurol. 2013 Dec;12(12):1141-50. doi: 10.1016/S1474-4422(13)70239-4. Epub 2013 Oct 18. |