DIalysis Symptom COntrol-Restless Legs Syndrome Trial

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The DISCO-RLS Trial is a randomized controlled trial to determine the safety and efficacy of pharmacologic therapy (ropinirole versus placebo and gabapentin versus placebo) for the treatment of Restless Legs Syndrome in patients with End Stage Renal Disease requiring hemodialysis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Population Health Research Institute
• Treatments: Gabapentin; gamma-Aminobutyric Acid; Ropinirole

Criteria

Inclusion Criteria:

• Age greater or equal to 18 years

• Has received at least 90 days of in-center hemodialysis at a frequency at least 3 times weekly

• RLS defined by 2012 Revised International Restless Legs Syndrome Study Group (IRLSSG) Diagnostic Criteria for RLS and of moderate severity defined by an IRLS score greater or equal to 10 with symptoms more than 2 days per week (see IRLS question #7)

• Provides informed consent

Exclusion Criteria:

• Hemoglobin<80g/L in the previous 4 weeks

• Intolerance to a dopamine agonists (e.g. pramipexole or ropinirole) or alpha 2 delta ligands (e.g. gabapentin, Neurontin, pregabalin, or Lyrica)

• Change in medication to treat RLS in previous 4 weeks

• Current pregnancy

• Planned kidney transplantation, travel or relocation in the next 6 months

• Unable to complete RLS symptom and HRQOL measurements due to language barrier or cognitive impairment