Dialysis Symptom COntrol – Restless Legs Syndrome Trial
The approach to restless leg syndrome (RLS) therapy in end stage renal disease (ESRD) lacks high quality evidence in the form of adequately powered RCTs and relies on the extrapolation of studies from the general population. However, this may not be valid given the multidimensional pathophysiology of RLS in ESRD. DISCO is a vanguard 4 treatment crossover (4 weeks each) randomized controlled trial with a single blind placebo run-in period. 24 participants will be enrolled in the pilot and 72 participants in the full trial. During the run-in period, participants will receive single blind placebo orally for 14 days. Participants who tolerate the run-in with no placebo response will be randomized to four treatments (gabapentin+pramipexole, gabapentin+placebo, placebo+pramipexole, placebo+placebo) each taken daily for 4 weeks with crossover. The results of the DISCO-RLS Trial will inform clinicians regarding the optimal pharmacologic therapy for RLS in hemodialysis (HD) with a focus on low fixed dose combination therapy to target multiple RLS pathways while avoiding drug intolerances clinically apparently with dose titration in the HD population.
Vanguard (pilot trial and full trial). 4 treatment crossover (4 weeks each) randomized controlled trial with a single blind placebo run-in period. Patients, investigators, care providers, outcome adjudicators, and analysts will be blinded to drug allocation.
Pilot trial: feasibility outcomes including the percentage of eligible patients entering the run-in period, the percentage of run-in failures, the number of patients randomized, protocol violations, and completion of follow-up.
Full trial: The primary outcome of the full trial is the proportion of individuals in each group who achieve a reduction in IRLS greater than its minimal clinically important difference of 3.
Michael Walsh and David Collister