DIalysis Symptom COntrol-Restless Legs Syndrome Trial (DISCO-RLS Trial): A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 3
- 主要终点
- International Restless Legs Syndrome Study Group Rating Scale (IRLS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study interventions will be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Gabapentin + Ropinirole
Gabapentin 100 mg capsule, once daily for 4 weeks. Ropinirole 0.50 mg capsule, once daily for 4 weeks.
干预措施: Gabapentin (Drug)
Gabapentin + Ropinirole
Gabapentin 100 mg capsule, once daily for 4 weeks. Ropinirole 0.50 mg capsule, once daily for 4 weeks.
干预措施: Ropinirole (Drug)
Gabapentin + Placebo Ropinirole
Gabapentin 100 mg capsule, once daily for 4 weeks. Ropinirole placebo 0.50 mg capsule, once daily for 4 weeks.
干预措施: Gabapentin (Drug)
Gabapentin + Placebo Ropinirole
Gabapentin 100 mg capsule, once daily for 4 weeks. Ropinirole placebo 0.50 mg capsule, once daily for 4 weeks.
干预措施: Placebo Ropinirole (Drug)
Ropinirole + Placebo Gabapentin
Gabapentin placebo 100 mg capsule, once daily for 4 weeks. Ropinirole 0.50 mg capsule, once daily for 4 weeks.
干预措施: Ropinirole (Drug)
Ropinirole + Placebo Gabapentin
Gabapentin placebo 100 mg capsule, once daily for 4 weeks. Ropinirole 0.50 mg capsule, once daily for 4 weeks.
干预措施: Placebo Gabapentin (Drug)
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.
干预措施: Placebo Gabapentin (Drug)
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.
干预措施: Placebo Ropinirole (Drug)
结局指标
主要结局
International Restless Legs Syndrome Study Group Rating Scale (IRLS)
时间窗: 18 weeks (Baseline, Run-In, Follow-up)
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.
次要结局
- Patient Global Impressions (PGI)(18 weeks (Baseline, Run-In, Follow-up))
- Restless Legs Syndrome-6 Scale (RLS-6)(18 weeks (Baseline, Run-In, Follow-up))
- Euro-Quality of Life Scale (EQ-5D-5L)(18 weeks (Baseline, Run-In, Follow-up))
- Incidence of falls, fractures and hospitalizations/emergency room visits due to altered level of consciousness.(18 weeks (Baseline, Run-In, Follow-up))