Trial Outcomes & Findings for Study of T3 for the Treatment of Fibromyalgia (NCT NCT00903877)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

51 participants

Primary outcome timeframe

12 weeks

Results posted on

2017-07-14

Participant milestones
Measure	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.
Overall Study STARTED	51
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	43

Reasons for withdrawal
Measure	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.
Overall Study Did not meet study criteria	33
Overall Study Withdrawal by Subject	3
Overall Study Adverse Event	2
Overall Study Lost to Follow-up	1
Overall Study Participation put on hold	4

Study of T3 for the Treatment of Fibromyalgia

Baseline characteristics by cohort
Measure	Placebo Followed by T3 n=51 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	51 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	35.35 years STANDARD_DEVIATION 7.76 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	51 participants n=5 Participants

Timeframe: 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).

Outcome measures
Measure	Placebo Followed by T3 n=8 Participants 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.
Visual Analogue Scale of Pain Intensity Placebo	5.71 Units on a scale Standard Deviation 1.82
Visual Analogue Scale of Pain Intensity Baseline	6.75 Units on a scale Standard Deviation 2.17
Visual Analogue Scale of Pain Intensity T3 Treatment (25 mcg)	5.13 Units on a scale Standard Deviation 2.95
Visual Analogue Scale of Pain Intensity T3 Treatment (50 mcg)	6.19 Units on a scale Standard Deviation 2.37

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events
Measure	Placebo Followed by T3 n=51 participants at risk All participants receive placebo, followed by 25 mcg of T3.
Cardiac disorders Tachycardia	2.0% 1/51 • Adverse event data was collected over the 12 week course of the study. The clinicaltrials.gov definition of adverse event was used. Adverse events were monitored without regard to the specific Adverse Event Term.

Other adverse events
Measure	Placebo Followed by T3 n=51 participants at risk All participants receive placebo, followed by 25 mcg of T3.
General disorders General	2.0% 1/51 • Adverse event data was collected over the 12 week course of the study. The clinicaltrials.gov definition of adverse event was used. Adverse events were monitored without regard to the specific Adverse Event Term.

Stanford University

Phone: (650) 498-6477