DIalysis Symptom COntrol-Restless Legs Syndrome Trial

NCT03806530 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2022-09-21

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03806530 on ClinicalTrials.gov