Efficacy of Tyrosine in Restless Legs Syndrome
This study is currently recruiting participants.
Verified May 2012 by Seton Brain and Spine Institute
Sponsor:
Seton Brain and Spine Institute
Collaborator:
Seton Family of Hospitals
Information provided by (Responsible Party):
Seton Brain and Spine Institute
ClinicalTrials.gov Identifier:
NCT01494766
First received: December 15, 2011
Last updated: May 10, 2012
Last verified: May 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 15, 2011 | ||||||||
| Last Updated Date | May 10, 2012 | ||||||||
| Start Date ICMJE | January 2012 | ||||||||
| Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01494766 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Efficacy of Tyrosine in Restless Legs Syndrome | ||||||||
| Official Title ICMJE | Pilot Study of the Efficacy of Tyrosine in Restless Legs Syndrome | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Restless Legs Syndrome (RLS) | ||||||||
| Intervention ICMJE | Dietary Supplement: L-Tyrosine
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.
Other Name: NOW Brand L-Tyrosine 750 mg Tablets |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 5 | ||||||||
| Estimated Completion Date | May 2012 | ||||||||
| Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01494766 | ||||||||
| Other Study ID Numbers ICMJE | CR-11-146 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Seton Brain and Spine Institute | ||||||||
| Study Sponsor ICMJE | Seton Brain and Spine Institute | ||||||||
| Collaborators ICMJE | Seton Family of Hospitals | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Seton Brain and Spine Institute | ||||||||
| Verification Date | May 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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