Back to results

L-Tyrosine Supplementation in Patients With Fibromyalgia

Primary Purpose

Fibromyalgia

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Tyrosine

Placebo

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Diet, Fibromyalgia, Pain, Drug, Amino-acid, Fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Pregnant
Age less than 18

Sites / Locations

Mount Sinai School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Tyrosine 1000 mg / day

Tyrosine 2000 mg / day

Placebo

Arm Description

Patients receive 1000 mg tyrosine per day.

Patients receive 2000 mg tyrosine per day.

Patients receive placebo daily.

Outcomes

Primary Outcome Measures

Pain Score

FIQ Score

Secondary Outcome Measures

Full Information

NCT ID

NCT01219049

First Posted

October 8, 2010

Last Updated

April 7, 2017

Sponsor

Icahn School of Medicine at Mount Sinai

1. Study Identification

Unique Protocol Identification Number

NCT01219049

Brief Title

L-Tyrosine Supplementation in Patients With Fibromyalgia

Official Title

L-Tyrosine Supplementation in Patients With Fibromyalgia

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Terminated

Why Stopped

Due to FDA comments, changes required unavailable resources. There are no results for this study.

Study Start Date

January 2010 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia

Keywords

Diet, Fibromyalgia, Pain, Drug, Amino-acid, Fatigue

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tyrosine 1000 mg / day

Arm Type

Experimental

Arm Description

Patients receive 1000 mg tyrosine per day.

Arm Title

Tyrosine 2000 mg / day

Arm Type

Experimental

Arm Description

Patients receive 2000 mg tyrosine per day.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Patients receive placebo daily.

Intervention Type

Drug

Intervention Name(s)

Tyrosine

Intervention Description

1000 mg / day

Intervention Type

Drug

Intervention Name(s)

Tyrosine

Intervention Description

2000 mg / day

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo daily

Primary Outcome Measure Information:

Title

Pain Score

Time Frame

daily for 21 days

Title

FIQ Score

Time Frame

Day 1

Title

FIQ Score

Time Frame

Day 21

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of fibromyalgia Pain greater than 4/10 Age greater than 18 Exclusion Criteria: Pregnant Age less than 18

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael A Mazzeffi, MD, MPH

Organizational Affiliation

Icahn School of Medicine at Mount Sinai

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mount Sinai School of Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

12. IPD Sharing Statement

Learn more about this trial

L-Tyrosine Supplementation in Patients With Fibromyalgia

We'll reach out to this number within 24 hrs