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NCT01219049 Clinical Trial

L-Tyrosine Supplementation in Patients With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:
L-Tyrosine Supplementation in Patients With Fibromyalgia

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01219049
Other study ID # 09-1144
Secondary ID
Status Terminated
Phase N/A
First received October 8, 2010
Last updated April 7, 2017
Start date January 2010
Est. completion date January 2011

Study information
Verified date April 2017
Source Icahn School of Medicine at Mount Sinai
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients in the study, who have a diagnosis of fibromyalgia, will be randomly assigned to take the amino acid L-tyrosine or placebo (blank pill) for 3 weeks. They will fill out questionnaires about their symptoms and see if they have any improvement. The investigators hypothesis is that taking tyrosine will help alleviate the symptoms of fibromyalgia.

Description:

Fibromyalgia is a chronic pain syndrome with few treatment options available. The amino-acid L-tyrosine is the precursor for norepinephrine in the central nervous system (CNS). Norepinephrine in the CNS has important roles in pain and mood modulation and descending inhibition of pain pathways. By giving the precursor L-tyrosine in high doses we believe that we can increase levels of norepinephrine in the CNS. To study this question we designed a randomized blinded pilot study of 30 patients. Patients are randomly assigned to one of 3 groups (placebo, tyrosine 1000mg/day, and tyrosine 2000mg/day.) for 3 weeks. Patients then complete the Brief Pain Inventory (BPI) daily and the Fibromyalgia impact questionnaire (FIQ) on day 1 and day 21. Patients also complete a drug diary. They are monitored weekly for progress during the study.

Recruitment information / eligibility
Status Terminated
Enrollment 15
Est. completion date January 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of fibromyalgia

- Pain greater than 4/10

- Age greater than 18

Exclusion Criteria:

- Pregnant

- Age less than 18

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tyrosine
1000 mg / day
• Tyrosine
2000 mg / day
• Placebo
Placebo daily

Locations
Country Name City State
United States Mount Sinai School of Medicine New York New York

Sponsors (1)
Lead Sponsor Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain Score daily for 21 days
Primary FIQ Score Day 1
Primary FIQ Score Day 21
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