DIalysis Symptom COntrol-Restless Legs Syndrome Trial
NCT03806530 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2022-09-21
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.
Conditions
- End Stage Renal Disease
- Restless Legs Syndrome
Interventions
- DRUG
-
Gabapentin
100 mg capsule
- DRUG
-
Ropinirole
0.50 mg capsule
- DRUG
-
Placebo Gabapentin
Placebo capsule
- DRUG
-
Placebo Ropinirole
Placebo capsule
Sponsors & Collaborators
-
Population Health Research Institute
lead OTHER
Principal Investigators
-
Dr. Michael Walsh, PhD,FRCPC(C) · Population Health Research Institute, McMaster University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-05-01
- Primary Completion
- 2021-12-14
- Completion
- 2022-07-19
Countries
- Canada
Study Locations
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