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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

Tracking Information
First Submitted Date  ICMJE January 14, 2019
First Posted Date  ICMJE January 16, 2019
Last Update Posted Date September 21, 2022
Actual Study Start Date  ICMJE May 1, 2019
Actual Primary Completion Date December 14, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 14, 2019)
International Restless Legs Syndrome (IRLS) Score [ Time Frame: 18 weeks (Baseline, Run-In, Follow-up) ]
The difference in IRLS scores for each of the treatment regimens.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2019)
  • 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.
  • 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
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2019)
  • Restless Legs Syndrome-6 Scale (RLS-6) [ Time Frame: 18 weeks (Baseline, Run-In, Follow-up) ]
    The difference in RLS-6 scores for each of the treatment regimens.
  • Patient Global Impressions (PGI) [ Time Frame: 18 weeks (Baseline, Run-In, Follow-up) ]
    The difference in PGI scores for each of the treatment regimens
  • EQ-5D-5L Score [ Time Frame: 18 weeks (Baseline, Run-In, Follow-up) ]
    The difference in EQ-5D-5L scores for each of the treatment regimens
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DIalysis Symptom COntrol-Restless Legs Syndrome Trial
Official Title  ICMJE DIalysis Symptom COntrol-Restless Legs Syndrome Trial (DISCO-RLS Trial): A Randomized Controlled Trial
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE
  • End Stage Renal Disease
  • Restless Legs Syndrome
Intervention  ICMJE
  • Drug: Gabapentin
    100 mg capsule
    Other Name: GD-Gabapentin
  • Drug: Ropinirole
    0.50 mg capsule
    Other Name: pms-Ropinirole
  • Drug: Placebo Gabapentin
    Placebo capsule
    Other Name: Placebo
  • Drug: Placebo Ropinirole
    Placebo capsule
    Other Name: Placebo
Study Arms  ICMJE
  • Active Comparator: Gabapentin + Ropinirole
    Gabapentin 100 mg capsule, once daily for 4 weeks. Ropinirole 0.50 mg capsule, once daily for 4 weeks.
    Interventions:
    • Drug: Gabapentin
    • Drug: 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.
    Interventions:
    • Drug: Gabapentin
    • Drug: Placebo Ropinirole
  • 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.
    Interventions:
    • Drug: Ropinirole
    • Drug: Placebo Gabapentin
  • 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.
    Interventions:
    • Drug: Placebo Gabapentin
    • Drug: Placebo Ropinirole
Publications * Collister D, Pohl K, Herrington G, Lee SF, Rabbat C, Tennankore K, Zimmermann D, Tangri N, Wald R, Manns B, Suri RS, Nadeau-Fredette AC, Goupil R, Silver SA, Walsh M. The DIalysis Symptom COntrol-Restless Legs Syndrome (DISCO-RLS) Trial: A Protocol for a Randomized, Crossover, Placebo-Controlled Blinded Trial. Can J Kidney Health Dis. 2020 Nov 26;7:2054358120968959. doi: 10.1177/2054358120968959. eCollection 2020.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 19, 2022)
52
Original Estimated Enrollment  ICMJE
 (submitted: January 14, 2019)
80
Actual Study Completion Date  ICMJE July 19, 2022
Actual Primary Completion Date December 14, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03806530
Other Study ID Numbers  ICMJE DISCO_RLS_001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Population Health Research Institute
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Population Health Research Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dr. Michael Walsh, PhD,FRCPC(C) Population Health Research Institute, McMaster University
PRS Account Population Health Research Institute
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP