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
  Purpose

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 Intervention
Fibromyalgia
Drug: Tyrosine
Drug: Placebo

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • 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 ]

Enrollment: 15
Study Start Date: January 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant
  • Age less than 18
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01219049

Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Michael A Mazzeffi, MD, MPH Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01219049     History of Changes
Other Study ID Numbers: 09-1144
Study First Received: October 8, 2010
Last Updated: March 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Diet
Fibromyalgia
Pain
Drug
Amino-acid
Fatigue

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

ClinicalTrials.gov processed this record on July 23, 2014