Pilot Study of the Efficacy of Tyrosine in Restless Legs Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- International RLS Survey Group (IRLSSG20) Score
研究概览
简要总结
Tyrosine is a non essential amino acid that is the precursor of the neurotransmitter, dopamine. Tyrosine is converted into Levodihydrophenylalanine (L-Dopa) and L-Dopa is subsequently and avidly converted into dopamine. It is well known that dopamine deficiency leads to the manifestations of restless legs syndrome (RLS). Studies have shown dopamine agonists and L-dopa to be effective in controlling symptoms. No studies to date have been done to determine the role of tyrosine in RLS. This open-label pilot study aims to determine the efficacy and tolerability of tyrosine in RLS, as current agents have limitations in treating RLS in addition to adding another possible agent to the investigators arsenal of treating RLS that maybe more cost efficient. In this pilot study, the dose of tyrosine will be escalated from 750 mg once daily by mouth (PO) up to 3000 mg once daily PO, as tolerated, in increments of 750 mg every week in patients who meet the inclusion criteria for RLS. Patients' symptoms will be monitored on a weekly basis for six weeks.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged 18 to 80 years and
- •Newly diagnosed (medication-naïve) as having restless legs syndrome (using the International Restless Legs Syndrome Study Group (IRLSSG20) diagnostic criteria with a score of greater than or equal to 15, see Appendix A) and
- •That interfered with sleep onset and/or maintenance for greater than four nights/week for a minimum of six months
- •Currently not receiving treatment for RLS
排除标准
- •Patients suffering from secondary RLS (other movement and/or primary sleep disorders, chronic renal insufficiency - calculated from the creatinine clearance, and/or iron deficiency - baseline serum ferritin level less than 10 ng/ml)
- •Patients currently on pharmacotherapy for RLS (not medication-naïve) or previous use of pharmacotherapy for RLS in the past
- •Patients that are pregnant and/or breastfeeding
- •Patients that are on levothyroxine or monoamine oxidase inhibitors
结局指标
主要结局
International RLS Survey Group (IRLSSG20) Score
时间窗: 6 weeks
Use of this survey to be used as a marker for severity of RLS symptoms and therefore efficacy of this medication.
次要结局
- Clinical global impression-global improvement (CGI-I) scale(6 weeks)
- Case Report Form(6 weeks)
- Medical Outcomes Study - Sleep Scale (MOS-SS)(6 weeks)