L-Tyrosine Supplementation in Patients With Fibromyalgia

NCT ID: NCT01219049

Last Updated: 2017-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-01-31

Brief Summary

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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

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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.

Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tyrosine 1000 mg / day

Patients receive 1000 mg tyrosine per day.

Group Type EXPERIMENTAL

Tyrosine

Intervention Type DRUG

1000 mg / day

Tyrosine 2000 mg / day

Patients receive 2000 mg tyrosine per day.

Group Type EXPERIMENTAL

Tyrosine

Intervention Type DRUG

2000 mg / day

Placebo

Patients receive placebo daily.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo daily

Interventions

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Tyrosine

1000 mg / day

Intervention Type DRUG

Tyrosine

2000 mg / day

Intervention Type DRUG

Placebo

Placebo daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnant
* Age less than 18
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael A Mazzeffi, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Mount Sinai School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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09-1144

Identifier Type: -

Identifier Source: org_study_id

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