Sean Mackey, M.D., Ph.D.
Study of T3 for the treatment of Fibromyalgia
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: T3
Phase:
N/AEligibility
Ages Eligible for Study:
18 years to 50 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key 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.
Key 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
Additional Study Details
Official Title:
T3 for fibromyalgia: a pilot double-blind non-randomized clinical trialAnticipated start date:
5/5/2009Lead Sponsor:
Stanford UniversityInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
Double BlindControl:
noneAssignment:
Cross OverEndpoints:
EfficacyPrimary Outcomes:
- Visual analogue scale of pain intensity
Total Number to be Enrolled:
20Total Number to be Enrolled at Stanford:
20More Information
Secondary ID(s):
- 16295
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
11/24/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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