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Efficacy of Tyrosine in Restless Legs Syndrome

Primary Purpose

Restless Legs Syndrome (RLS)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
L-Tyrosine
Sponsored by
Seton Healthcare Family
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Restless Legs Syndrome (RLS) focused on measuring RLS

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seton Family of Hospitals

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Tyrosine

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Medical Outcomes Study - Sleep Scale (MOS-SS)
Use of the MOS-SS to determine severity of RLS symptoms and efficacy of medication.
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.

Full Information

First Posted
December 15, 2011
Last Updated
April 25, 2017
Sponsor
Seton Healthcare Family
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1. Study Identification

Unique Protocol Identification Number
NCT01494766
Brief Title
Efficacy of Tyrosine in Restless Legs Syndrome
Official Title
Pilot Study of the Efficacy of Tyrosine in Restless Legs Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seton Healthcare Family

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restless Legs Syndrome (RLS)
Keywords
RLS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tyrosine
Arm Type
Other
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
L-Tyrosine
Other Intervention Name(s)
NOW Brand L-Tyrosine 750 mg Tablets
Intervention Description
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.
Primary Outcome Measure Information:
Title
International RLS Survey Group (IRLSSG20) Score
Description
Use of this survey to be used as a marker for severity of RLS symptoms and therefore efficacy of this medication.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Clinical global impression-global improvement (CGI-I) scale
Description
Use of the CGI-I scale as a secondary outcome measure to determine severity of RLS symptoms and efficacy of medication.
Time Frame
6 weeks
Title
Medical Outcomes Study - Sleep Scale (MOS-SS)
Description
Use of the MOS-SS to determine severity of RLS symptoms and efficacy of medication.
Time Frame
6 weeks
Title
Case Report Form
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Facility Information:
Facility Name
Seton Family of Hospitals
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States

12. IPD Sharing Statement

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Efficacy of Tyrosine in Restless Legs Syndrome

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