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

• Status: Suspended
• Trial end date: 2021-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alberta
• Treatments: Gabapentin; gamma-Aminobutyric Acid; Ropinirole

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