L-Tyrosine Supplementation in Patients With Fibromyalgia

Not Applicable

Terminated

• Conditions: Fibromyalgia
• Interventions: Drug: Placebo; Drug: Tyrosine

• Registration Number: NCT01219049
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-10-08
• Study First Submitted QC: 2010-10-08
• Study First Posted: 2010-10-13
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-07
• Last Update Posted: 2017-04-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Diagnosis of fibromyalgia
• Pain greater than 4/10
• Age greater than 18

Exclusion Criteria

• Pregnant
• Age less than 18

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients receive placebo daily.
Tyrosine 1000 mg / day	Tyrosine	Patients receive 1000 mg tyrosine per day.
Tyrosine 2000 mg / day	Tyrosine	Patients receive 2000 mg tyrosine per day.

Primary Outcome Measures

Name	Time	Method
Pain Score	daily for 21 days
FIQ Score	Day 21

Trial Locations

Locations (1)

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States