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).
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 205
- Locations
- 1
- Primary Endpoint
- Changes in the IRLS score between the two treatment arms will be compared
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
OXN PR
Different daily doses; intake every 12 hours
Intervention: Oxycodone naloxone prolonged release tablets (OXN PR) (Drug)
PLA
Different daily doses; intake every 12 hours
Intervention: Oxycodone naloxone prolonged release tablets (OXN PR) (Drug)
PLA
Different daily doses; intake every 12 hours
Intervention: Placebo (PLA) (Other)
Outcomes
Primary Outcomes
Changes in the IRLS score between the two treatment arms will be compared
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported