L-Tyrosine Supplementation in Patients With Fibromyalgia
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||L-Tyrosine Supplementation in Patients With Fibromyalgia|
- Pain Score [ Time Frame: daily for 21 days ] [ Designated as safety issue: No ]
- FIQ Score [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
- FIQ Score [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Experimental: Tyrosine 1000 mg / day
Patients receive 1000 mg tyrosine per day.
1000 mg / day
Experimental: Tyrosine 2000 mg / day
Patients receive 2000 mg tyrosine per day.
2000 mg / day
Placebo Comparator: Placebo
Patients receive placebo daily.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01219049
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|Principal Investigator:||Michael A Mazzeffi, MD, MPH||Mount Sinai School of Medicine|