Efficacy of Tyrosine in Restless Legs Syndrome

NCT01494766 | Completed

• 1 other identifier: CR-11-146
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Restless Legs Syndrome (RLS)

Keywords

RLS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Clinical global impression-global improvement (CGI-I) scale

  6 weeks

• Medical Outcomes Study - Sleep Scale (MOS-SS)

  6 weeks

• Case Report Form

  6 weeks

Study Arms (1)

Tyrosine

OTHER

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

Interventions

L-Tyrosine DIETARY_SUPPLEMENT

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.

Also known as: NOW Brand L-Tyrosine 750 mg Tablets

Tyrosine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seton Healthcare Family: lead

Study Sites (1)

Seton Family of Hospitals

Austin, Texas, 78701, United States

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Tyrosine

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Intervention Hierarchy (Ancestors)

Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2011
• First Posted: December 19, 2011
• Study Start: January 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: November 1, 2012
• Last Updated: April 27, 2017

Record last verified: 2017-04

Locations

US (1)