Status:
COMPLETED
DIalysis Symptom COntrol-Restless Legs Syndrome Trial
Lead Sponsor:
Population Health Research Institute
Conditions:
End Stage Renal Disease
Restless Legs Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 Restle...
Detailed Description
The DISCO-RLS Trial is a randomized controlled trial to determine whether or not a fixed, low-dose therapy with ropinirole and/or gabapentin is safe and effective compared to either alone or placebo f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2022
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03806530
Start Date
May 1 2019
End Date
July 19 2022
Last Update
September 21 2022
Active Locations (3)
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1
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada, B3H 2Y9
2
St. Joseph's Hamilton Healthcare
Hamilton, Ontario, Canada, L8N 4A6
3
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 7W9