NCT03806530

DIalysis Symptom COntrol-Restless Legs Syndrome Trial

DIalysis Symptom COntrol-Restless Legs Syndrome Trial (DISCO-RLS Trial): A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Population Health Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• End Stage Renal Disease
• Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	Gabapentin	100 mg capsule
DRUG	Ropinirole	0.50 mg capsule
DRUG	Placebo Gabapentin	Placebo capsule
DRUG	Placebo Ropinirole	Placebo capsule

Timeline

• Start date: 2019-05-01
• Primary completion: 2021-12-14
• Completion: 2022-07-19
• First posted: 2019-01-16
• Last updated: 2022-09-21

Locations

3 sites across 1 country: Canada