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L-Tyrosine Supplementation in Patients With Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01219049
Recruitment Status : Terminated (Due to FDA comments, changes required unavailable resources. There are no results for this study.)
First Posted : October 13, 2010
Last Update Posted : April 11, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Fibromyalgia Drug: Tyrosine Drug: Placebo

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: L-Tyrosine Supplementation in Patients With Fibromyalgia
Study Start Date : January 2010
Primary Completion Date : January 2011
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
Drug Information available for: Tyrosine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Tyrosine 1000 mg / day
Patients receive 1000 mg tyrosine per day.
Drug: Tyrosine
1000 mg / day
Experimental: Tyrosine 2000 mg / day
Patients receive 2000 mg tyrosine per day.
Drug: Tyrosine
2000 mg / day
Placebo Comparator: Placebo
Patients receive placebo daily.
Drug: Placebo
Placebo daily

Primary Outcome Measures :
  1. Pain Score [ Time Frame: daily for 21 days ]
  2. FIQ Score [ Time Frame: Day 1 ]
  3. FIQ Score [ Time Frame: Day 21 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant
  • Age less than 18

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01219049

United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Principal Investigator: Michael A Mazzeffi, MD, MPH Icahn School of Medicine at Mount Sinai

Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01219049     History of Changes
Other Study ID Numbers: 09-1144
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Icahn School of Medicine at Mount Sinai:

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases