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

NCT03708237 | Terminated Phase 2

• 1 other identifier: Pro00084427
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 4

Brief 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

Restless Legs Syndrome; End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• Evaluate the effectiveness of ropinirole and gabapentin on the severity of RLS symptoms in the hemodialysis population.

  The International Restless Legs Syndrome Study Group (IRLS) rating scale was developed to measure the severity of RLS symptoms over the preceding seven days. The rating scale takes approximately 10 minutes to complete and consists of 10 questions rated from 0 - 4 (0 = none, 4 = very severe). The scale includes diagnostic features and questions to evaluate the intensity/frequency of RLS, associated sleep problems and impact of symptoms on mood and daily functioning. The total score ranges from 0 to 40; mild (1 - 10), moderate (11 - 20), severe (21 - 30) and very severe (31 - 40).

  up to 4 & 6 months after start of intervention.

Secondary Outcomes (4)

• Evaluate the impact of ropinirole and gabapentin on the quality of life.

  EQ-5D-5L collected at baseline, and 1, 2, 4 & 6 months after start of intervention.

• Evaluate the impact of ropinirole and gabapentin on the quality of sleep.

  MOSS-SS collected at baseline, and 1, 2, 4 & 6 months after start of intervention.

• Evaluate the impact of ropinirole and gabapentin on the symptom burden.

  The 10 item ESAS-r: Renal collected at baseline, and 1, 2, 4 & 6 months after start of intervention.

• Validate the addition of RLS and difficulty sleeping items on the Edmonton Symptom Assessment System Revised: Renal (ESAS-r: Renal).

  The restless legs and difficulty sleeping items added to the ESAR-r: renal will be collected at baseline, and 1, 2, 4 & 6 months after start of intervention.

Study Arms (3)

Placebos

PLACEBO COMPARATOR

Placebo Dose: Not Applicable Route: Mouth Regimen: Daily 2 hours before bed Duration: 6 months

Drug: Placebos

Ropinirole

EXPERIMENTAL

Drug: ropinirole Dose: 0.25 - 2 mg as tolerated Route: Mouth Regimen: Daily 2 hours before bed Duration: 6 months

Drug: Ropinirole

Gabapentin

EXPERIMENTAL

Drug: gabapentin Dose: 100 - 300 mg as tolerated Route: Mouth Regimen: Daily 2 hours before bed Duration: 6 months

Drug: Gabapentin

Interventions

Ropinirole DRUG

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.

Also known as: ACT-ROPINIROLE

Ropinirole

Gabapentin DRUG

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.

Also known as: APO-GABAPENTIN

Gabapentin

Placebos DRUG

Opaque gel capsules filled with methylcellulose 1500 filler

Placebos

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (4)

Edmonton General Continuing Care Centre

Edmonton, Canada

Location

Grey Nuns Community Hospital

Edmonton, Canada

Location

Royal Alexandra Hospital

Edmonton, Canada

Location

University of Alberta Hospital

Edmonton, Canada

Location

MeSH Terms

Conditions

Restless Legs Syndrome; Kidney Failure, Chronic

Interventions

ropinirole; Gabapentin

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2018
• First Posted: October 17, 2018
• Study Start: February 19, 2019
• Primary Completion: November 6, 2019
• Study Completion: December 11, 2019
• Last Updated: July 12, 2022

Record last verified: 2021-06

Locations

CA (4)