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Efficacy of Tyrosine in Restless Legs Syndrome

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关键词

抽象

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.

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

Restless Legs Syndrome (RLS)

干预/治疗

Dietary Supplement: Tyrosine

-

手臂组

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
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]

Use of this survey to be used as a marker for severity of RLS symptoms and therefore efficacy of this medication.

次要成果指标

1. Clinical global impression-global improvement (CGI-I) scale [6 weeks]

Use of the CGI-I scale as a secondary outcome measure to determine severity of RLS symptoms and efficacy of medication.

2. Medical Outcomes Study - Sleep Scale (MOS-SS) [6 weeks]

Use of the MOS-SS to determine severity of RLS symptoms and efficacy of medication.

3. Case Report Form [6 weeks]

Use of a history and physical examination (limited neurological exam) to be used as a secondary assessment measure of RLS symptom severity and medication efficacy. They will be charted in case report format.

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