DIalysis Symptom COntrol-Restless Legs Syndrome Trial

Overview

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.

Full Title of Study: “DIalysis Symptom COntrol-Restless Legs Syndrome Trial (DISCO-RLS Trial): A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 14, 2021

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.

Interventions

  • Drug: Gabapentin
    • 100 mg capsule
  • Drug: Ropinirole
    • 0.50 mg capsule
  • Drug: Placebo Gabapentin
    • Placebo capsule
  • Drug: Placebo Ropinirole
    • Placebo capsule

Arms, Groups and Cohorts

  • Active Comparator: Gabapentin + Ropinirole
    • Gabapentin 100 mg capsule, once daily for 4 weeks. Ropinirole 0.50 mg capsule, once daily for 4 weeks.
  • 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.
  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Population Health Research Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dr. Michael Walsh, PhD,FRCPC(C), Principal Investigator, Population Health Research Institute, McMaster University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.