Safety and Efficacy of Rasagiline in Restless Legs Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 52
- 试验地点
- 8
- 主要终点
- Change in International Restless Legs Syndrome Study Group Rating Scale (IRLS) score from Baseline to Week 12
研究概览
简要总结
The purpose of this study is to find out if rasagiline improves RLS symptoms. We also want to make sure rasagiline is safe to give people with RLS.
详细描述
The primary objective is to determine if rasagiline, at a dosage of 1mg/day, is non-futile for the treatment of RLS, as measured by the International RLS Study Group Rating Scale (IRLS). The primary outcome variable will be the change in IRLS from baseline to Week 12.
The secondary objectives are to determine if rasagiline, at a dosage of 1mg/day, is safe and well-tolerated in participants with RLS. Also, to determine if rasagiline improves measures of global clinical change, sleep quality, excessive sleepiness, quality of life, or depressive symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Men and women at least 18 years of age, capable of providing informed consent
- •Diagnosed with idiopathic RLS, defined as meeting the International RLS Study Group diagnostic criteria without evidence for secondary causes of RLS
- •Moderate or severe symptoms, defined as a score of 15 or greater on the International RLS Study Group Rating Scale (IRLS)
- •Not currently receiving treatment for RLS. A 30-day washout period will be required for participants on dopamine agonists or other therapies. Stable doses of iron supplementation will be allowed
- •On a stable dose of the following antidepressants, for at least 30 days prior to baseline visit:
- •Amitriptyline, up to 50mg/day
- •Trazodone, up to 100mg/day
- •Citalopram, up to 20mg/day
- •Escitalopram, up to 10mg/day
- •Paroxetine, up to 30mg/day
- •Sertraline, up to 100mg/day
- •Female subjects must not be of childbearing potential or must agree to use of contraception for duration of study
排除标准
- •Signs consistent with a secondary cause of RLS:
- •History of initial unresponsiveness to dopaminergic RLS treatment despite adequate dose of initial therapy
- •Use of another MAO inhibitor within 30 days of baseline visit
- •Allergy or adverse reaction to rasagiline
- •Prior adverse reaction to tyramine-containing foods
- •Use of meperidine or other opiates within 30 days of the baseline visit
- •Use of benzodiazepines within 30 days of the baseline visit
- •Use of antidepressants, including TCAs, SSRIs, and SNRIs, except for those permitted as listed above
- •Use of other drugs or supplements contraindicated with rasagiline, including St. John's wort, mirtazapine, cyclobenzaprine, dextromethorphan, cold products that contain ephedrine, pseudoephedrine
- •Scheduled to undergo elective surgery during the course of the study
- •Active medical or psychiatric illness that requires changes to treatment during the course of the study or jeopardize the subject's ability to remain in the study
研究组 & 干预措施
rasagiline
干预措施: rasagiline (Drug)
placebo (sugar pill)
干预措施: placebo (sugar pill) (Drug)
结局指标
主要结局
Change in International Restless Legs Syndrome Study Group Rating Scale (IRLS) score from Baseline to Week 12
时间窗: Screening, Baseline, Week 6, Week 12
The IRLS is a 10-question scale that contains questions about both the frequency and severity of RLS symptoms, as well as secondary aspects such as sleep quality and daytime tiredness.
次要结局
- Adverse events(12 weeks)
- Tolerability (ability to complete study on assigned dosage)(12 weeks)
- Change in Beck Depression Inventory from Baseline to Week 12(Baseline, Week 6, Week 12)
- Change in Clinical Global Impression - Change from Baseline to Weeks 12(Baseline, Week 6, Week 12)
- Change in Medical Outcome Study Sleep Scale from Baseline to Week 12(Baseline, Week 6, Week 12)
- Change in Johns Hopkins Restless Legs Syndrome Quality of Life Questionnaire from Baseline to Week 12(Baseline, week 6, Week 12)
- Change in Epworth Sleepiness Scale from Baseline to Week 12(Baseline, Week 6, Week 12)
研究者
Colleen P Harman
Project Manager
University of Virginia