Oxycodone/Naloxone Prolonged Release (OXN PR) Compared to Placebo to Demonstrate Improvement in Symptoms of Restless Legs Syndrome (RLS) in Subjects With Moderate to Severe Idiopathic RLS With Daytime Symptoms

Summary

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.

Timeline

Start

2010-04

Primary completion

2011-06

Completion

2011-06

Outcome

Met primary endpoint

paper mean change after 12 weeks was -16·5 (SD 11·3) in the prolonged release oxycodone-naloxone group and -9·4 (SD 10·9) in the placebo group PMID 24140442 ↗

paper mean difference between groups at 12 weeks 8·15, 95% CI 5·46-10·85; p<0·0001 PMID 24140442 ↗

Publications

• 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.
• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Naloxone	Small molecule	20 mg	—
Subject	Oxycodone	Other / unclassified	40 mg	—

Indications

No indication recorded.