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

Mundipharma Research GmbH & Co KG205 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

205

Conditions

Moderate to Severe Idiopathic RLS With Daytime Symptoms

Interventions

Oxycodone naloxone prolonged release tablets (OXN PR)DRUG

Different daily doses; intake every 12 hours

Placebo (PLA)OTHER

Different daily doses; intake every 12 hours

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Paracelsus Elena Klinik

Kassel, Germany

Unnamed facility

Barcelona, Spain

Unnamed facility

Gothenburg, Sweden

Outcomes

Primary Outcomes

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.

Time frame: 12 weeks and a 6 month extension

Data from ClinicalTrials.gov

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