NCT01219049

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 13, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

1 year

First QC Date

October 8, 2010

Last Update Submit

April 7, 2017

Conditions

Fibromyalgia

Keywords

DietFibromyalgiaPainDrugAmino-acidFatigue

Outcome Measures

Primary Outcomes (3)

  • Pain Score

    daily for 21 days

  • FIQ Score

    Day 1

  • FIQ Score

    Day 21

Study Arms (3)

Tyrosine 1000 mg / day

EXPERIMENTAL

Patients receive 1000 mg tyrosine per day.

Drug: Tyrosine

Tyrosine 2000 mg / day

EXPERIMENTAL

Patients receive 2000 mg tyrosine per day.

Drug: Tyrosine

Placebo

PLACEBO COMPARATOR

Patients receive placebo daily.

Drug: Placebo

Interventions

TyrosineDRUG

1000 mg / day

Tyrosine 1000 mg / day
PlaceboDRUG

Placebo daily

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnant
  • Age less than 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

FibromyalgiaPainFatigue

Interventions

Tyrosine

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Michael A Mazzeffi, MD, MPH

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2010

First Posted

October 13, 2010

Study Start

January 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

April 11, 2017

Record last verified: 2017-04

Locations

US(1)