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Thyroid Hormone for Remyelination in Multiple Sclerosis (MS): A Safety and Dose Finding Study (MST3K)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02760056
Recruitment Status : Completed
First Posted : May 3, 2016
Results First Posted : November 19, 2018
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Michelle Cameron, Oregon Health and Science University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Sequential Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Multiple Sclerosis
Interventions Drug: Liothyronine sodium
Drug: Placebo
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Liothyronine (Cytomel) Placebo
Hide Arm/Group Description

Subjects will be divided into 4 groups. The first group will take 25 mcg twice daily for one week. The second group will take 37.5 mcg twice daily for one week. The third group will take 50 mcg twice daily for one week. The firth group will take 75 mcg twice daily for one week

Liothyronine sodium: Subjects will be divided into 4 groups of progressively escalating doses. If the study is fully enrolled, each group will have 6 subjects 4 will receive the active treatment and 2 will receive the placebo. The first group will receive 25 mcg twice daily for one week. The second group will receive 37.5 mcg twice daily for one week. The third group will receive 50 mcg twice daily for one week. The forth group will receive 75 mcg twice daily for one week.

Subject will take matching placebo twice a day for one week

Placebo: Patient will receive a matching placebo to take twice daily for one week.

Period Title: Overall Study
Started 10 5
Completed 10 5
Not Completed 0 0
Arm/Group Title Liothyronine (Cytomel) Placebo Total
Hide Arm/Group Description

Subjects will be divided into 4 groups. The first group will take 25 mcg twice daily for one week. The second group will take 37.5 mcg twice daily for one week. The third group will take 50 mcg twice daily for one week. The firth group will take 75 mcg twice daily for one week

Liothyronine sodium: Subjects will be divided into 4 groups of progressively escalating doses. Each group will have 6 subjects 4 will receive the active treatment and 2 will receive the placebo. The first group will receive 25 mcg twice daily for one week. The second group will receive 37.5 mcg twice daily for one week. The third group will receive 50 mcg twice daily for one week. The forth group will receive 75 mcg twice daily for one week.

Subject will take matching placebo twice a day for one week

Placebo: Patient will receive a matching placebo to take twice daily for one week.

Total of all reporting groups
Overall Number of Baseline Participants 10 5 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants 5 participants 15 participants
39
(30 to 49)
38.4
(21 to 46)
38.8
(21 to 49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 5 participants 15 participants
Female
4
  40.0%
2
  40.0%
6
  40.0%
Male
6
  60.0%
3
  60.0%
9
  60.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 5 participants 15 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  10.0%
0
   0.0%
1
   6.7%
White
9
  90.0%
4
  80.0%
13
  86.7%
More than one race
0
   0.0%
1
  20.0%
1
   6.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
MS Subtype  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 5 participants 15 participants
Relapsing Remitting Multiple Sclerosis
9
  90.0%
5
 100.0%
14
  93.3%
Secondary Progressive Multiple Sclerosis
1
  10.0%
0
   0.0%
1
   6.7%
1.Primary Outcome
Title Determine the Maximum Tolerated Dose (MTD) of Oral L-T3 in Subjects With MS
Hide Description MTD per protocol (dose level one category below dose at which study was stopped due to intolerance or meeting criteria for cessation)
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with MS taking L-T3 (10) excluding those taking placebo (5)
Arm/Group Title Liothyronine (Cytomel)
Hide Arm/Group Description:

Subjects will be divided into 4 groups. The first group will take 25 mcg twice daily for one week. The second group will take 37.5 mcg twice daily for one week. The third group will take 50 mcg twice daily for one week. The firth group will take 75 mcg twice daily for one week

Liothyronine sodium: Subjects will be divided into 4 groups of progressively escalating doses. Each group will have 6 subjects 4 will receive the active treatment and 2 will receive the placebo. The first group will receive 25 mcg twice daily for one week. The second group will receive 37.5 mcg twice daily for one week. The third group will receive 50 mcg twice daily for one week. The forth group will receive 75 mcg twice daily for one week.

Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: mcg daily with BID dosing
75
2.Secondary Outcome
Title Reliability of Visual Evoked Potential (VEP) Testing (ICC)
Hide Description P100 latency will be compared before and after treatment with L-T3 in subjects receiving the active treatment to assess reliability of the test for future assessment of treatment effect.
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with MS taking L-T3 or placebo
Arm/Group Title Liothyronine (Cytomel) Placebo All Participants
Hide Arm/Group Description:

Subjects will be divided into 4 groups. The first group will take 25 mcg twice daily for one week. The second group will take 37.5 mcg twice daily for one week. The third group will take 50 mcg twice daily for one week. The firth group will take 75 mcg twice daily for one week

Liothyronine sodium: Subjects will be divided into 4 groups of progressively escalating doses. Each group will have 6 subjects 4 will receive the active treatment and 2 will receive the placebo. The first group will receive 25 mcg twice daily for one week. The second group will receive 37.5 mcg twice daily for one week. The third group will receive 50 mcg twice daily for one week. The forth group will receive 75 mcg twice daily for one week.

Subject will take matching placebo twice a day for one week

Placebo: Patient will receive a matching placebo to take twice daily for one week.

Measure value across cohorts.
Overall Number of Participants Analyzed 10 5 15
Measure Type: Number
Unit of Measure: Intraclass Coefficient (ICC)
ICC - Right Eye 0.852 0.679 0.824
ICC - Left Eye 0.746 0.966 0.845
ICC- Mixed Model 0.889 0.963 0.924
Time Frame 1 week
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Liothyronine (Cytomel) Placebo
Hide Arm/Group Description

Subjects will be divided into 4 groups. The first group will take 25 mcg twice daily for one week. The second group will take 37.5 mcg twice daily for one week. The third group will take 50 mcg twice daily for one week. The firth group will take 75 mcg twice daily for one week

Liothyronine sodium: Subjects will be divided into 4 groups of progressively escalating doses. Each group will have 6 subjects 4 will receive the active treatment and 2 will receive the placebo. The first group will receive 25 mcg twice daily for one week. The second group will receive 37.5 mcg twice daily for one week. The third group will receive 50 mcg twice daily for one week. The forth group will receive 75 mcg twice daily for one week.

Patient will receive a matching placebo to take twice daily for one week.
All-Cause Mortality
Liothyronine (Cytomel) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)      0/5 (0.00%)    
Hide Serious Adverse Events
Liothyronine (Cytomel) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/5 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Liothyronine (Cytomel) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/10 (60.00%)      2/5 (40.00%)    
Cardiac disorders     
Tachycardia *  1/10 (10.00%)  2 1/5 (20.00%)  7
Gastrointestinal disorders     
Loose Stool *  5/10 (50.00%)  5 0/5 (0.00%)  0
Abdominal Pain *  1/10 (10.00%)  1 0/5 (0.00%)  0
Yellow stool *  1/10 (10.00%)  1 0/5 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Muscle Pain * [1]  1/10 (10.00%)  1 0/5 (0.00%)  0
Psychiatric disorders     
Anxiety *  1/10 (10.00%)  1 0/5 (0.00%)  0
Poor Sleep *  4/10 (40.00%)  1/5 (20.00%) 
Skin and subcutaneous tissue disorders     
Increased severity in post-Tecfidera flushing *  1/10 (10.00%)  1 0/5 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Back and Leg pain
Self-reporting of BP, HR. 1 missed dose in the drug arm. VEP testing was conducted by multiple technicians and read by multiple attending physicians; though visit one and two were more often conducted by the same tech/attending.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anna Orban
Organization: OHSU
Phone: 503-494-3549
EMail: orban@ohsu.edu
Layout table for additonal information
Responsible Party: Michelle Cameron, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02760056    
Other Study ID Numbers: IRB 15101
First Submitted: April 5, 2016
First Posted: May 3, 2016
Results First Submitted: May 15, 2017
Results First Posted: November 19, 2018
Last Update Posted: November 19, 2018