Efficacy of Tyrosine in Restless Legs Syndrome
关键词
抽象
日期
最后验证: | 03/31/2017 |
首次提交: | 12/14/2011 |
提交的预估入学人数: | 12/15/2011 |
首次发布: | 12/18/2011 |
上次提交的更新: | 04/24/2017 |
最近更新发布: | 04/26/2017 |
实际学习开始日期: | 12/31/2011 |
预计主要完成日期: | 04/30/2012 |
预计完成日期: | 10/31/2012 |
状况或疾病
干预/治疗
Dietary Supplement: Tyrosine
相
手臂组
臂 | 干预/治疗 |
---|---|
Other: Tyrosine Dietary Supplement: L-Tyrosine
Other Names:
NOW Brand L-Tyrosine 750 mg Tablets
-Tyrosine 750 mg PO every day for 7 days, then increase to 1500 mg PO every day for 7 days, then increase to 2250 mg PO every day for 7 days, then increase to 3000 mg PO every day for remainder of the study. | Dietary Supplement: Tyrosine L-Tyrosine 750 mg PO every day for 7 days, then increase to 1500 mg PO every day for 7 days, then increase to 2250 mg PO every day for 7 days, then increase to 3000 mg PO every day for remainder of the study. |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: 1. Men and women aged 18 to 80 years and 2. 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 3. That interfered with sleep onset and/or maintenance for greater than four nights/week for a minimum of six months 4. Currently not receiving treatment for RLS Exclusion Criteria: 1. 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) 2. Patients currently on pharmacotherapy for RLS (not medication-naïve) or previous use of pharmacotherapy for RLS in the past 3. Patients that are pregnant and/or breastfeeding 4. Patients that are on levothyroxine or monoamine oxidase inhibitors |
结果
主要结果指标
1. International RLS Survey Group (IRLSSG20) Score [6 weeks]
次要成果指标
1. Clinical global impression-global improvement (CGI-I) scale [6 weeks]
2. Medical Outcomes Study - Sleep Scale (MOS-SS) [6 weeks]
3. Case Report Form [6 weeks]