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

Population Health Research Institute (PHRI)

Status and phase: Completed; Phase 3

Conditions: End Stage Renal Disease; Restless Legs Syndrome

Treatments: Drug: Gabapentin; Drug: Placebo Ropinirole; Drug: Placebo Gabapentin; Drug: Ropinirole

Study type: Interventional

Funder types: Other

Identifiers

NCT03806530

DISCO_RLS_001

Details and patient eligibility

About

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 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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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52 participants in 4 patient groups, including a placebo group

Gabapentin + Ropinirole

Active Comparator group

Description:

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

Treatment:

Drug: Ropinirole

Drug: Gabapentin

Gabapentin + Placebo Ropinirole

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo Ropinirole

Drug: Gabapentin

Ropinirole + Placebo Gabapentin

Placebo Comparator group

Description:

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

Treatment:

Drug: Ropinirole

Drug: Placebo Gabapentin

Placebo Gabapentin + Placebo Ropinirole

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo Gabapentin

Drug: Placebo Ropinirole