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Study of T3 for the Treatment of Fibromyalgia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sean Mackey, Stanford University
ClinicalTrials.gov Identifier:
NCT00903877
First received: May 15, 2009
Last updated: June 15, 2017
Last verified: June 2017
  Purpose
Determine if T3 - the active form of thyroid hormone - is beneficial in fibromyalgia. Determine the feasibility and promise of an appropriately powered future prospective randomized controlled study of using T3 (the active form of thyroid hormone) for the treatment of fibromyalgia. We specifically aim to assess the feasibility, cost, obstacles and promise of conducting a prospective controlled study in the future.

Condition Intervention
Fibromyalgia Drug: T3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: T3 for Fibromyalgia: a Pilot Double-blind Non-randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Sean Mackey, Stanford University:

Primary Outcome Measures:
  • Visual Analogue Scale of Pain Intensity [ Time Frame: 12 weeks ]
    Patients rated their pain at baseline, placebo, T3 at 25 mcg, and T3 at 50 mcg. The scale ranged from 0 (no pain) to 10 (pain as bad as it can be).


Enrollment: 51
Study Start Date: May 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Placebo followed by T3
Participants receive placebo for 4 weeks. Following placebo, participants begin T3 treatment at 25 mcg per day, for 4 weeks. Following this, participants begin T3 treatment at 50 mcg per day, for 4 more weeks.
Drug: T3
Patients receive T3 in a dose of 25mcg and 50mcg

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-50
  2. Meet american college of rheumatology criteria for fibromyalgia
  3. at baseline report an average pain of 4 or more on a brief Pain Inventory.
  4. can climb 2 flights of stairs without shortness of breath.

Exclusion Criteria:

  1. new medication change in the last 2 months
  2. any cardiac disease at all
  3. known thyroid disease before or after thyroid screening bloodwork
  4. unstable medical or psychiatric disease.
  5. Known inflammatory or rheumatic disease other than fibromyalgia
  6. substance abuse in the last year
  7. suicidality or depression as indicated by a Beck Depression Inventory of 30 or above
  8. concomitant herbal medications
  9. multiple severe medication allergies
  10. the assessment of the research team that inclusion of the subject could in some way compromise the safety and validity of the study.
  11. diabetes
  12. smoking
  13. Known uncontrolled hypertension
  14. known uncontrolled hypercholesterolemia
  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: NCT00903877

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Ian R Carroll Stanford University
  More Information

Responsible Party: Sean Mackey, Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00903877     History of Changes
Other Study ID Numbers: SU-04272009-2419
16295
Study First Received: May 15, 2009
Results First Received: April 3, 2017
Last Updated: June 15, 2017

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 August 18, 2017