Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
52 participants
INTERVENTIONAL
2019-05-01
2022-07-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Gabapentin + Ropinirole
Gabapentin 100 mg capsule, once daily for 4 weeks. Ropinirole 0.50 mg capsule, once daily for 4 weeks.
Gabapentin
100 mg capsule
Ropinirole
0.50 mg capsule
Gabapentin + Placebo Ropinirole
Gabapentin 100 mg capsule, once daily for 4 weeks. Ropinirole placebo 0.50 mg capsule, once daily for 4 weeks.
Gabapentin
100 mg capsule
Placebo Ropinirole
Placebo capsule
Ropinirole + Placebo Gabapentin
Gabapentin placebo 100 mg capsule, once daily for 4 weeks. Ropinirole 0.50 mg capsule, once daily for 4 weeks.
Ropinirole
0.50 mg capsule
Placebo Gabapentin
Placebo capsule
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.
Placebo Gabapentin
Placebo capsule
Placebo Ropinirole
Placebo capsule
Interventions
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Gabapentin
100 mg capsule
Ropinirole
0.50 mg capsule
Placebo Gabapentin
Placebo capsule
Placebo Ropinirole
Placebo capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Population Health Research Institute
OTHER
Responsible Party
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Principal Investigators
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Dr. Michael Walsh, PhD,FRCPC(C)
Role: PRINCIPAL_INVESTIGATOR
Population Health Research Institute, McMaster University
Locations
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Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
St. Joseph's Hamilton Healthcare
Hamilton, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Countries
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References
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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.
Other Identifiers
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DISCO_RLS_001
Identifier Type: -
Identifier Source: org_study_id
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