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Completed

NCT Number: NCT03806530

DIalysis Symptom COntrol-Restless Legs Syndrome Trial

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nova Scotia Health Authority, Halifax, Nova Scotia, Canada

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About this study

The DISCO-RLS Trial is a randomized controlled trial to determine whether or not a fixed, low-dose therapy with ropinirole and/or gabapentin is safe and effective compared to either alone or placebo for the treatment of Restless Legs Syndrome in patients with End Stage Renal Disease receiving hemodialysis. DISCO-RLS will randomize a total of 80 participants. Participants will be randomized to 1 of 8 treatment sequences. Each sequence is composed of 4 periods and in each period participants will receive 1 of 4 possible combinations of study medications (gabapentin+ropinirole, gabapentin+placebo ropinirole, ropinirole+placebo gabapentin, placebo gabapentin+placebo ropinirole). Eligible participants will complete a 1-week Run-In period followed by 4 periods of 4 weeks each for a total of 16-week follow-up after randomization. A final study visit will be completed at the end of the 16 week follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age greater or equal to 18 years
  • Has received at least 90 days of in-center hemodialysis at a frequency at least 3 times weekly
  • RLS defined by 2012 Revised International Restless Legs Syndrome Study Group (IRLSSG) Diagnostic Criteria for RLS and of moderate severity defined by an IRLS score greater or equal to 10 with symptoms more than 2 days per week (see IRLS question #7)
  • Provides informed consent

Exclusion criteria

  • Hemoglobin<80g/L in the previous 4 weeks
  • Intolerance to a dopamine agonists (e.g. pramipexole or ropinirole) or alpha 2 delta ligands (e.g. gabapentin, Neurontin, pregabalin, or Lyrica)
  • Change in medication to treat RLS in previous 4 weeks
  • Current pregnancy
  • Planned kidney transplantation, travel or relocation in the next 6 months
  • Unable to complete RLS symptom and HRQOL measurements due to language barrier or cognitive impairment

Treatment and study plan

Gabapentin

Drug

100 mg capsule

Other names: GD-Gabapentin

Ropinirole

Drug

0.50 mg capsule

Other names: pms-Ropinirole

Placebo gabapentin

Drug

Placebo capsule

Other names: Placebo

Placebo Ropinirole

Drug

Placebo capsule

Other names: Placebo

Primary outcomes

  1. International Restless Legs Syndrome Study Group Rating Scale (IRLS)

    Time frame: 18 weeks (Baseline, Run-In, Follow-up)

    The IRLS is a measure of severity of Restless Legs Syndrome. It includes 10 items, measured on a scale of 0-4. A score of 1-10 indicates mild severity, 11-20 indicates moderate severity, 21-30 is severe and 31-40 is very severe. Primary outcome is the difference in IRLS scores for each of the treatment regimens.

Secondary outcomes

  1. Restless Legs Syndrome-6 Scale (RLS-6)

    Time frame: 18 weeks (Baseline, Run-In, Follow-up)

    The RLS-6 is a measure of severity of Restless Legs Syndrome for the past week. It includes 6 items, measured on a scale of 0-10. Each item is measured from no symptoms (score of 0) to very severe symptoms (score of 10). Secondary outcome is the difference in RLS-6 scores for each of the treatment regimens.

  2. Patient Global Impressions (PGI)

    Time frame: 18 weeks (Baseline, Run-In, Follow-up)

    The PGI is a measure of Restless Legs Syndrome symptom severity. It includes 1 item, measured on a scale of 1-7. 1 indicates mild severity, 3 indicates moderate severity, 5 is severe and 7 is very severe. Secondary outcome is the difference in PGI scores for each of the treatment regimens

  3. Euro-Quality of Life Scale (EQ-5D-5L)

    Time frame: 18 weeks (Baseline, Run-In, Follow-up)

    The EQ-5D-5L is a measure of health status. It includes 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and a visual analogue scale of 0-100 (0 being worst health and 100 being best health). The scale is measured by levels. Level 1 indicating no problems, 2 indicating slight problems, 3 indicating moderate problems, 4 indicating severe problems and 5 indicating extreme problems. Secondary outcome is the difference in EQ-5D-5L scores for each of the treatment regimens

  4. Incidence of falls, fractures and hospitalizations/emergency room visits due to altered level of consciousness.

    Time frame: 18 weeks (Baseline, Run-In, Follow-up)

    The total number of falls, fractures, or hospitalization/emergency rooms visits due to confusion/delirium or altered mental state.

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Registry information

Official study title

DIalysis Symptom COntrol-Restless Legs Syndrome Trial (DISCO-RLS Trial): A Randomized Controlled Trial

Acronym: DISCO-RLS

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jan 16, 2019
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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