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Effectiveness of Ropinirole and Gabapentin for the Treatment of RLS in Patients on Maintenance HD

NCT03708237 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2022-07-12

No results posted yet for this study

Summary

Restless legs syndrome (RLS) is a neurologic disorder characterized by 1) an urge to move the legs, 2) uncomfortable sensations in the legs, 3) symptoms that are often worse the evening or when at rest , and 4) may be temporarily relieved by physical activity.

The overall prevalence of RLS in the general population is estimated to be around 10%, however, it is significantly in the end stage kidney disease (ESKD) population is significantly higher (approximately 30%). Studies have shown that RLS has a substantial negative impact on both the physical and the mental health dimensions of quality of life (QOL), such as depression, anxiety, pain, fatigue and sleep disorder.

While non-pharmacological treatments should be considered for all patients, pharmacological management of RLS is indicated when the affects patient's sleep or quality of life. Gabapentin and dopamine agonists such as ropinirole are usually the first choices in treating RSL. Although these medications are also used in patients with renal impairment, few studies provide treatment data for the hemodialysis population. Treatment recommendations for this population are largely based on data obtained in the general population.

This study aims to evaluate effectiveness of ropinirole and gabapentin for the treatment of restless legs syndrome in patients on maintenance hemodialysis.

Conditions

Interventions

DRUG

Ropinirole

ROPINIROLE has been approved by Health Canada for the treatment of idiopathic Parkinson's disease. Immediate release ropinirole is an orally administered non-ergoline dopamine agonist that is extensively metabolized by the liver. Ropinirole has not been approved by Health Canada for the treatment of moderate to severe RLS.

DRUG

Gabapentin

GABAPENTIN has been approved by Health Canada for the management of epilepsy. Immediate release gabapentin is an orally administered anticonvulsant primarily excreted through the kidneys. Gabapentin has not been approved by Health Canada for the treatment of moderate to severe RLS.

DRUG

Placebos

Opaque gel capsules filled with methylcellulose 1500 filler

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-19
Primary Completion
2019-11-06
Completion
2019-12-11

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT03708237 on ClinicalTrials.gov