Open Label Assessment of Pitolisant (Wakix) as Adjunct Therapy for Patients With Refractory Restless Legs Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- International RLS Rating Scale (IRLS)
研究概览
简要总结
This is an open-label trial in Restless Legs Syndrome (RLS) patients inadequately treated with standard therapy, defined by an IRLS score greater than 15. Investigators hypothesize that the study drug, Pitolisant (Wakix), may improve RLS symptoms.
详细描述
This is an open-label trial in RLS patients who have been inadequately treated with standard therapies, defined by an IRLS > 15. This trial consists of four study center visits (weeks 0, 4, 8, and 16) and four telephone visits (weeks 1, 3, 11, and a post safety phone call at week 17).
Subjects will titrate pitolisant for three weeks, starting with a dose of 8.9 mg at week 1, then increase to 17.8 mg at week 2, and a final increase to maximum dosage of 35.6 mg at week 3. If subjects are unable to tolerate the highest dose, they may reduce their dose to 17.8 mg. Titration of the drug will be monitored via telephone visits. During weeks 0-8, subjects will continue to take their current RLS medications. From week 8-16, subjects may either reduce or stop their other RLS medications as mutually agreed upon with investigator.
Several questionnaire assessments will be conducted throughout the study to monitor the subjects. Subjects will complete the International RLS Rating Scale (IRLS), Restless Legs Syndrome - 6 Scale (RLS-6), RLS Quality of Life Questionnaire (RLSQoL), Fatigue Severity Scale (FSS), Hamilton Depression Scale (HDS), Montreal Cognitive Assessment (MoCA), Epworth Sleepiness Scale (ESS), Clinical Global Impressions (CGI), and Clinical Global Impressions-Change (CGI-C).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •RLS diagnosed by standard criteria with an IRLS > 15 while taking at least 1 RLS medication
- •Stable RLS medications for at least 2 weeks prior to study entry
排除标准
- •MoCA < 24
- •Concurrent untreated sleep disorders, not felt to be stable
- •Subjects with any significant, unstable cardiovascular, liver, lung, renal, psychiatric, or neurological diseases (not including RLS)
- •Intravenous iron within 4 weeks of study entry
- •Breast feeding or pregnancy determined by urine pregnancy test in subjects where pregnancy is possible (pre-menopausal, sexually active women)
- •Subjects with previous allergic reaction or lack of tolerability to Pitolisant
研究组 & 干预措施
Pitolisant (Wakix)
Pitolisant will be titrated weekly until maximum dosage of 35.6 mg. Titration is dependent on subjects response.
干预措施: Pitolisant (Drug)
结局指标
主要结局
International RLS Rating Scale (IRLS)
时间窗: At week 8
This is a subjective scale to measure the severity of RLS within the past week.
次要结局
- The Restless Legs Syndrome - 6 Scale (RLS-6)(Baseline, 4 weeks, 8 weeks, and 16 weeks)
- Fatigue Severity Scale (FSS)(Baseline, 4 weeks, 8 weeks, and 16 weeks)
- Hamilton Depression Scale (HDS)(Baseline, 4 weeks, 8 weeks, and 16 weeks)
- Restless Legs Syndrome Quality of Life Questionnaire (RLSQoL)(Baseline, 4 weeks, 8 weeks, and 16 weeks)
- Montreal Cognitive Assessment (MoCA)(Baseline, 4 weeks, 8 weeks, and 16 weeks)
- Epworth Sleepiness Scale (ESS)(Baseline, 4 weeks, 8 weeks, and 16 weeks)
- Clinical Global Impressions - Change(1 week, 2 weeks, 4 weeks, 8 weeks, 11 weeks, 16 weeks, and 17 weeks)
研究者
William Ondo, MD
Principal Investigator
The Methodist Hospital Research Institute