Efficacy of Tyrosine in Restless Legs Syndrome

Restless Legs Syndrome (RLS) Clinical Trial

Official title:

Pilot Study of the Efficacy of Tyrosine in Restless Legs Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01494766
• Other study ID #: CR-11-146
• Status: Completed
• Phase: N/A
• First received: December 15, 2011
• Last updated: April 25, 2017
• Start date: January 2012
• Est. completion date: November 2012

Study information

• Verified date: April 2017
• Source: Seton Healthcare Family
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: November 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome
• Restless Legs Syndrome (RLS)
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Seton Family of Hospitals	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Seton Healthcare Family

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International RLS Survey Group (IRLSSG20) Score	Use of this survey to be used as a marker for severity of RLS symptoms and therefore efficacy of this medication.	6 weeks
Secondary	Clinical global impression-global improvement (CGI-I) scale	Use of the CGI-I scale as a secondary outcome measure to determine severity of RLS symptoms and efficacy of medication.	6 weeks
Secondary	Medical Outcomes Study - Sleep Scale (MOS-SS)	Use of the MOS-SS to determine severity of RLS symptoms and efficacy of medication.	6 weeks
Secondary	Case Report Form	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.	6 weeks