Study of T3 for the Treatment of Fibromyalgia

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00903877
• Collaborator: (none)
• Enrollment: 51
• Location: 1
• Arm: 1
• Duration (Months): 25
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Fibromyalgia	Drug: T3	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 51 participants
• Allocation: N/A
• 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
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Visual Analogue Scale of Pain Intensity [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Stanford University School of Medicine	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Ian R Carroll, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sean Mackey, Assistant Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT00903877
• Other Study ID Numbers: SU-04272009-2419; 16295
• First Posted: May 19, 2009
• Last Update Posted: Jul 14, 2017
• Last Verified: Jun 1, 2017

• Additional relevant MeSH terms: Fibromyalgia; Myofascial Pain Syndromes

Study Results

Participant Flow

Arm/Group Title	Placebo Followed by T3
Arm/Group Description	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.
Period Title: Overall Study
STARTED	51
COMPLETED	8
NOT COMPLETED	43

Baseline Characteristics

Arm/Group Title	Placebo Followed by T3
Arm/Group Description	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.
Overall Participants	51
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	51 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.35 (7.76)
Sex: Female, Male (Count of Participants)
Female	50 98%
Male	1 2%
Region of Enrollment (participants) [Number]
United States	51 100%

Outcome Measures

1. Primary Outcome

Title	Visual Analogue Scale of Pain Intensity
Description	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).
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Followed by T3
Arm/Group Description	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.
Measure Participants	8
Baseline	6.75 (2.17)
Placebo	5.71 (1.82)
T3 Treatment (25 mcg)	5.13 (2.95)
T3 Treatment (50 mcg)	6.19 (2.37)

Adverse Events

Time Frame	Adverse event data was collected over the 12 week course of the study.
Adverse Event Reporting Description	The clinicaltrials.gov definition of adverse event was used. Adverse events were monitored without regard to the specific Adverse Event Term.
Arm/Group Title	Placebo Followed by T3
Arm/Group Description	All participants receive placebo, followed by 25 mcg of T3.
All Cause Mortality
	Placebo Followed by T3
	Affected / at Risk (%)	# Events
Total	0/51 (0%)
Serious Adverse Events
	Placebo Followed by T3
	Affected / at Risk (%)	# Events
Total	1/51 (2%)
Cardiac disorders
Tachycardia	1/51 (2%)
Other (Not Including Serious) Adverse Events
	Placebo Followed by T3
	Affected / at Risk (%)	# Events
Total	1/51 (2%)
General disorders
General	1/51 (2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.