Effectiveness of Ropinirole and Gabapentin for the Treatment of RLS in Patients on Maintenance HD
Restless Legs Syndrome, End Stage Renal Disease
About this trial
This is an interventional treatment trial for Restless Legs Syndrome
Eligibility Criteria
Inclusion Criteria:
ESKD requiring hemodialysis
A symptom severity score of at least 4/10 on the restless legs ESAS-r: Renal question for two consecutive reporting periods (i.e over two months)
No RLS medication for two weeks prior to study period. Washout Period: Individuals that are receiving RLS medication but are still reporting a severity score of at least 4/10 on the restless legs ESAS-r: Renal they may be eligible if they discontinue their RLS medication for two weeks prior to baseline.
At least 18 years of age
Exclusion Criteria:
Dialysis vintage less than 3 months
Unstable medical conditions that prevents taking the study drugs or conditions that could affect efficacy treatment
Pregnancy
Previous adverse effects to gabapentin or ropinirole such as allergic reaction or augmentation
History of drug/alcohol abuse
Cognitive Impairment
Unable to understand English
Sites / Locations
- Edmonton General Continuing Care Centre
- Grey Nuns Community Hospital
- Royal Alexandra Hospital
- University of Alberta Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Experimental
Experimental
Placebos
Ropinirole
Gabapentin
Placebo Dose: Not Applicable Route: Mouth Regimen: Daily 2 hours before bed Duration: 6 months
Drug: ropinirole Dose: 0.25 - 2 mg as tolerated Route: Mouth Regimen: Daily 2 hours before bed Duration: 6 months
Drug: gabapentin Dose: 100 - 300 mg as tolerated Route: Mouth Regimen: Daily 2 hours before bed Duration: 6 months