Clinical trial NCT03806530: DIalysis Symptom COntrol-Restless Legs Syndrome Trial
Official title: DIalysis Symptom COntrol-Restless Legs Syndrome Trial (DISCO-RLS Trial): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: End Stage Renal Disease
Restless Legs Syndrome
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: International Restless Legs Syndrome Study Group Rating Scale (IRLS)
timeFrame: 18 weeks (Baseline, Run-In, Follow-up)
Secondary outcomes:
measure: Restless Legs Syndrome-6 Scale (RLS-6)
timeFrame: 18 weeks (Baseline, Run-In, Follow-up)
measure: Patient Global Impressions (PGI)
timeFrame: 18 weeks (Baseline, Run-In, Follow-up)
measure: Euro-Quality of Life Scale (EQ-5D-5L)
timeFrame: 18 weeks (Baseline, Run-In, Follow-up)
measure: Incidence of falls, fractures and hospitalizations/emergency room visits due to altered level of consciousness.
timeFrame: 18 weeks (Baseline, Run-In, Follow-up)
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
city: Hamilton
country: Canada
facility: St. Joseph's Hamilton Healthcare
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: Population Health Research Institute, McMaster University
name: Dr. Michael Walsh, PhD,FRCPC(C)
role: PRINCIPAL_INVESTIGATOR
References:
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.