Efficacy of Tyrosine in Restless Legs Syndrome
Recruitment status was Recruiting
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study of the Efficacy of Tyrosine in Restless Legs Syndrome|
- International RLS Survey Group (IRLSSG20) Score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Use of this survey to be used as a marker for severity of RLS symptoms and therefore efficacy of this medication.
- Clinical global impression-global improvement (CGI-I) scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Use of the CGI-I scale as a secondary outcome measure to determine severity of RLS symptoms and efficacy of medication.
- Medical Outcomes Study - Sleep Scale (MOS-SS) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Use of the MOS-SS to determine severity of RLS symptoms and efficacy of medication.
- Case Report Form [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||May 2012|
|Estimated Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Dietary Supplement: L-Tyrosine
Please refer to this study by its ClinicalTrials.gov identifier: NCT01494766
|Contact: Hanul Bhandari, MDfirstname.lastname@example.org|
|Contact: Jason Shen, MDemail@example.com|
|United States, Texas|
|Seton Family of Hospitals||Recruiting|
|Austin, Texas, United States, 78701|
|Contact 512-324-7890 firstname.lastname@example.org|
|Principal Investigator: Hanul Bhandari, MD|
|Sub-Investigator: Jason Shen, MD|
|Sub-Investigator: Osvaldo Perurena, MD|