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

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 OXN PR Compared to Subjects Taking Placebo (PLA).

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01112644

Enrollment

205

Registered

2010-04-28

Start date

2010-04-30

Completion date

2011-06-30

Last updated

2018-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to Severe Idiopathic RLS With Daytime Symptoms

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).

Interventions

DRUGOxycodone naloxone prolonged release tablets (OXN PR)

Different daily doses; intake every 12 hours

OTHERPlacebo (PLA)

Different daily doses; intake every 12 hours

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Germany, Spain, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026