Status:
COMPLETED
Efficacy of Tyrosine in Restless Legs Syndrome
Lead Sponsor:
Seton Healthcare Family
Conditions:
Restless Legs Syndrome (RLS)
Eligibility:
All Genders
18-80 years
Phase:
NA
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 conve...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01494766
Start Date
January 1 2012
End Date
November 1 2012
Last Update
April 27 2017
Active Locations (1)
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1
Seton Family of Hospitals
Austin, Texas, United States, 78701