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

Primary Purpose

End Stage Renal Disease, Restless Legs Syndrome

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Gabapentin
Ropinirole
Placebo Gabapentin
Placebo Ropinirole
Sponsored by
Population Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nova Scotia Health Authority
  • St. Joseph's Hamilton Healthcare
  • The Ottawa Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Placebo Comparator

Placebo Comparator

Arm Label

Gabapentin + Ropinirole

Gabapentin + Placebo Ropinirole

Ropinirole + Placebo Gabapentin

Placebo Gabapentin + Placebo Ropinirole

Arm Description

Gabapentin 100 mg capsule, once daily for 4 weeks. Ropinirole 0.50 mg capsule, once daily for 4 weeks.

Gabapentin 100 mg capsule, once daily for 4 weeks. Ropinirole placebo 0.50 mg capsule, once daily for 4 weeks.

Gabapentin placebo 100 mg capsule, once daily for 4 weeks. Ropinirole 0.50 mg capsule, once daily for 4 weeks.

Gabapentin placebo 100 mg capsule, once daily for 4 weeks. Ropinirole placebo 0.50 mg capsule, once daily for 4 weeks.

Outcomes

Primary Outcome Measures

International Restless Legs Syndrome Study Group Rating Scale (IRLS)
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

Restless Legs Syndrome-6 Scale (RLS-6)
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)
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)
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.
The total number of falls, fractures, or hospitalization/emergency rooms visits due to confusion/delirium or altered mental state.

Full Information

First Posted
January 14, 2019
Last Updated
September 19, 2022
Sponsor
Population Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03806530
Brief Title
DIalysis Symptom COntrol-Restless Legs Syndrome Trial
Acronym
DISCO-RLS
Official Title
DIalysis Symptom COntrol-Restless Legs Syndrome Trial (DISCO-RLS Trial): A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
December 14, 2021 (Actual)
Study Completion Date
July 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Population Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Restless Legs Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The study interventions will be blinded.
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gabapentin + Ropinirole
Arm Type
Active Comparator
Arm Description
Gabapentin 100 mg capsule, once daily for 4 weeks. Ropinirole 0.50 mg capsule, once daily for 4 weeks.
Arm Title
Gabapentin + Placebo Ropinirole
Arm Type
Placebo Comparator
Arm Description
Gabapentin 100 mg capsule, once daily for 4 weeks. Ropinirole placebo 0.50 mg capsule, once daily for 4 weeks.
Arm Title
Ropinirole + Placebo Gabapentin
Arm Type
Placebo Comparator
Arm Description
Gabapentin placebo 100 mg capsule, once daily for 4 weeks. Ropinirole 0.50 mg capsule, once daily for 4 weeks.
Arm Title
Placebo Gabapentin + Placebo Ropinirole
Arm Type
Placebo Comparator
Arm Description
Gabapentin placebo 100 mg capsule, once daily for 4 weeks. Ropinirole placebo 0.50 mg capsule, once daily for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
GD-Gabapentin
Intervention Description
100 mg capsule
Intervention Type
Drug
Intervention Name(s)
Ropinirole
Other Intervention Name(s)
pms-Ropinirole
Intervention Description
0.50 mg capsule
Intervention Type
Drug
Intervention Name(s)
Placebo Gabapentin
Other Intervention Name(s)
Placebo
Intervention Description
Placebo capsule
Intervention Type
Drug
Intervention Name(s)
Placebo Ropinirole
Other Intervention Name(s)
Placebo
Intervention Description
Placebo capsule
Primary Outcome Measure Information:
Title
International Restless Legs Syndrome Study Group Rating Scale (IRLS)
Description
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.
Time Frame
18 weeks (Baseline, Run-In, Follow-up)
Secondary Outcome Measure Information:
Title
Restless Legs Syndrome-6 Scale (RLS-6)
Description
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.
Time Frame
18 weeks (Baseline, Run-In, Follow-up)
Title
Patient Global Impressions (PGI)
Description
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
Time Frame
18 weeks (Baseline, Run-In, Follow-up)
Title
Euro-Quality of Life Scale (EQ-5D-5L)
Description
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
Time Frame
18 weeks (Baseline, Run-In, Follow-up)
Title
Incidence of falls, fractures and hospitalizations/emergency room visits due to altered level of consciousness.
Description
The total number of falls, fractures, or hospitalization/emergency rooms visits due to confusion/delirium or altered mental state.
Time Frame
18 weeks (Baseline, Run-In, Follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Michael Walsh, PhD,FRCPC(C)
Organizational Affiliation
Population Health Research Institute, McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nova Scotia Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
St. Joseph's Hamilton Healthcare
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 7W9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33294203
Citation
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.
Results Reference
derived

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DIalysis Symptom COntrol-Restless Legs Syndrome Trial

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