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Efficacy of Tyrosine in Restless Legs Syndrome

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ClinicalTrials.gov Identifier: NCT01494766
Recruitment Status : Completed
First Posted : December 19, 2011
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
Seton Healthcare Family

Brief Summary:
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.

Condition or disease Intervention/treatment
Restless Legs Syndrome (RLS) Dietary Supplement: L-Tyrosine

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of the Efficacy of Tyrosine in Restless Legs Syndrome
Study Start Date : January 2012
Primary Completion Date : May 2012
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs
Drug Information available for: Tyrosine
U.S. FDA Resources

Arm Intervention/treatment
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: L-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.
Other Name: NOW Brand L-Tyrosine 750 mg Tablets



Primary Outcome Measures :
  1. International RLS Survey Group (IRLSSG20) Score [ Time Frame: 6 weeks ]
    Use of this survey to be used as a marker for severity of RLS symptoms and therefore efficacy of this medication.


Secondary Outcome Measures :
  1. Clinical global impression-global improvement (CGI-I) scale [ Time Frame: 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) [ Time Frame: 6 weeks ]
    Use of the MOS-SS to determine severity of RLS symptoms and efficacy of medication.

  3. Case Report Form [ Time Frame: 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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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01494766


Locations
United States, Texas
Seton Family of Hospitals
Austin, Texas, United States, 78701
Sponsors and Collaborators
Seton Healthcare Family

Responsible Party: Seton Healthcare Family
ClinicalTrials.gov Identifier: NCT01494766     History of Changes
Other Study ID Numbers: CR-11-146
First Posted: December 19, 2011    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017

Keywords provided by Seton Healthcare Family:
RLS

Additional relevant MeSH terms:
Syndrome
Psychomotor Agitation
Restless Legs Syndrome
Disease
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Parasomnias
Mental Disorders