View Clinical Trial (Medical Research Study)
Pilot Study of the Efficacy of Tyrosine in Restless Legs Syndrome
| City: |
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Austin |
| State: |
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Texas |
| Zip Code: |
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78701 |
| Conditions: |
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Restless Legs Syndrome (RLS) |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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
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| NCT ID: |
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NCT01494766 |
| Primary Contact: |
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Hanul Bhandari, MD
Phone: 5123247890
Email: hbhandari@seton.org
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| Backup Contact: |
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Email: jshen@seton.org
Jason Shen, MD
Phone: 5123247890
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| Location Contact: |
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Austin, Texas 78701
United States
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
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