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L-Tyrosine Supplementation in Patients With Fibromyalgia

This study has been terminated.
(Due to FDA comments, changes required unavailable resources. There are no results for this study.)
Sponsor:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01219049
First received: October 8, 2010
Last updated: March 7, 2012
Last verified: March 2012
History of Changes

October 8, 2010
March 7, 2012
January 2010
January 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01219049 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
L-Tyrosine Supplementation in Patients With Fibromyalgia
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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Fibromyalgia
  • Drug: Tyrosine
    1000 mg / day
  • Drug: Tyrosine
    2000 mg / day
  • Drug: Placebo
    Placebo daily
  • Experimental: Tyrosine 1000 mg / day
    Patients receive 1000 mg tyrosine per day.
    Intervention: Drug: Tyrosine
  • Experimental: Tyrosine 2000 mg / day
    Patients receive 2000 mg tyrosine per day.
    Intervention: Drug: Tyrosine
  • Placebo Comparator: Placebo
    Patients receive placebo daily.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
15
January 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant
  • Age less than 18
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01219049
09-1144
No
Mount Sinai School of Medicine
Mount Sinai School of Medicine
Not Provided
Principal Investigator: Michael A Mazzeffi, MD, MPH Mount Sinai School of Medicine
Mount Sinai School of Medicine
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP