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

Phase 3

Completed

• Conditions: Moderate to Severe Idiopathic RLS With Daytime Symptoms
• Interventions: Drug: Oxycodone naloxone prolonged release tablets (OXN PR); Other: Placebo (PLA)

• Registration Number: NCT01112644
• Lead Sponsor: Mundipharma Research GmbH & Co KG

Brief 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.

Detailed Description

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).

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-23
• Study First Submitted QC: 2010-04-27
• Study First Posted: 2010-04-28
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-19
• Last Update Posted: 2018-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

Inclusion Criteria

• Moderate to severe idiopathic RLS with daytime symptoms

Exclusion Criteria

• Females who are pregnant or lactating.
• Subjects with evidence of significant structural abnormalities of the gastrointestinal tract.
• Subjects with evidence of impaired liver/kidney function upon entry into the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OXN PR	Oxycodone naloxone prolonged release tablets (OXN PR)	Different daily doses; intake every 12 hours
PLA	Oxycodone naloxone prolonged release tablets (OXN PR)	Different daily doses; intake every 12 hours
PLA	Placebo (PLA)	Different daily doses; intake every 12 hours

Primary Outcome Measures

Name	Time	Method
Changes in the IRLS score between the two treatment arms will be compared	12 weeks and a 6 month extension	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.

Trial Locations

Locations (1)

Paracelsus Elena Klinik; 🇩🇪 Kassel, Germany