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DIalysis Symptom COntrol-Restless Legs Syndrome Trial (DISCO-RLS)

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ClinicalTrials.gov Identifier: NCT03806530
Recruitment Status : Completed
First Posted : January 16, 2019
Last Update Posted : September 21, 2022
Sponsor:
Information provided by (Responsible Party):
Population Health Research Institute

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Restless Legs Syndrome Drug: Gabapentin Drug: Ropinirole Drug: Placebo Gabapentin Drug: Placebo Ropinirole Phase 3

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants will be randomly allocated 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).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The study interventions will be blinded.
Primary Purpose: Treatment
Official Title: DIalysis Symptom COntrol-Restless Legs Syndrome Trial (DISCO-RLS Trial): A Randomized Controlled Trial
Actual Study Start Date : May 1, 2019
Actual Primary Completion Date : December 14, 2021
Actual Study Completion Date : July 19, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Gabapentin + Ropinirole
Gabapentin 100 mg capsule, once daily for 4 weeks. Ropinirole 0.50 mg capsule, once daily for 4 weeks.
 Drug: Gabapentin
100 mg capsule
Other Name: GD-Gabapentin

Drug: Ropinirole
0.50 mg capsule
Other Name: pms-Ropinirole
Placebo Comparator: Gabapentin + Placebo Ropinirole
Gabapentin 100 mg capsule, once daily for 4 weeks. Ropinirole placebo 0.50 mg capsule, once daily for 4 weeks.
 Drug: Gabapentin
100 mg capsule
Other Name: GD-Gabapentin

Drug: Placebo Ropinirole
Placebo capsule
Other Name: Placebo
Placebo Comparator: Ropinirole + Placebo Gabapentin
Gabapentin placebo 100 mg capsule, once daily for 4 weeks. Ropinirole 0.50 mg capsule, once daily for 4 weeks.
 Drug: Ropinirole
0.50 mg capsule
Other Name: pms-Ropinirole

Drug: Placebo Gabapentin
Placebo capsule
Other Name: Placebo
Placebo Comparator: Placebo Gabapentin + Placebo Ropinirole
Gabapentin placebo 100 mg capsule, once daily for 4 weeks. Ropinirole placebo 0.50 mg capsule, once daily for 4 weeks.
 Drug: Placebo Gabapentin
Placebo capsule
Other Name: Placebo

Drug: Placebo Ropinirole
Placebo capsule
Other Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03806530


Locations
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Canada, Nova Scotia
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
St. Joseph's Hamilton Healthcare
Hamilton, Ontario, Canada, L8N 4A6
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 7W9
Sponsors and Collaborators
Population Health Research Institute
Investigators
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Principal Investigator: Dr. Michael Walsh, PhD,FRCPC(C) Population Health Research Institute, McMaster University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT03806530    
Other Study ID Numbers: DISCO_RLS_001
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: September 21, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psychomotor Agitation
Restless Legs Syndrome
Kidney Failure, Chronic
Syndrome
Disease
Pathologic Processes
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Parasomnias
Mental Disorders
Gabapentin
Ropinirole
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants