Trial Outcomes & Findings for Thyroid Hormone for Remyelination in Multiple Sclerosis (MS): A Safety and Dose Finding Study (NCT NCT02760056)
NCT ID: NCT02760056
Last Updated: 2018-11-19
Results Overview
MTD per protocol (dose level one category below dose at which study was stopped due to intolerance or meeting criteria for cessation)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
1 week
Results posted on
2018-11-19
Participant Flow
Participant milestones
| Measure |
Liothyronine (Cytomel)
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.
|
Placebo
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.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
5
|
|
Overall Study
COMPLETED
|
10
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Thyroid Hormone for Remyelination in Multiple Sclerosis (MS): A Safety and Dose Finding Study
Baseline characteristics by cohort
| Measure |
Liothyronine (Cytomel)
n=10 Participants
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.
|
Placebo
n=5 Participants
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
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39 years
n=5 Participants
|
38.4 years
n=7 Participants
|
38.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
MS Subtype
Relapsing Remitting Multiple Sclerosis
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
MS Subtype
Secondary Progressive Multiple Sclerosis
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 weekPopulation: Participants with MS taking L-T3 (10) excluding those taking placebo (5)
MTD per protocol (dose level one category below dose at which study was stopped due to intolerance or meeting criteria for cessation)
Outcome measures
| Measure |
Liothyronine (Cytomel)
n=10 Participants
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.
|
Placebo
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.
|
All Participants
Measure value across cohorts.
|
|---|---|---|---|
|
Determine the Maximum Tolerated Dose (MTD) of Oral L-T3 in Subjects With MS
|
75 mcg daily with BID dosing
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 weekPopulation: Participants with MS taking L-T3 or placebo
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.
Outcome measures
| Measure |
Liothyronine (Cytomel)
n=10 Participants
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.
|
Placebo
n=5 Participants
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.
|
All Participants
n=15 Participants
Measure value across cohorts.
|
|---|---|---|---|
|
Reliability of Visual Evoked Potential (VEP) Testing (ICC)
ICC - Left Eye
|
0.746 Intraclass Coefficient (ICC)
|
0.966 Intraclass Coefficient (ICC)
|
0.845 Intraclass Coefficient (ICC)
|
|
Reliability of Visual Evoked Potential (VEP) Testing (ICC)
ICC - Right Eye
|
0.852 Intraclass Coefficient (ICC)
|
0.679 Intraclass Coefficient (ICC)
|
0.824 Intraclass Coefficient (ICC)
|
|
Reliability of Visual Evoked Potential (VEP) Testing (ICC)
ICC- Mixed Model
|
0.889 Intraclass Coefficient (ICC)
|
0.963 Intraclass Coefficient (ICC)
|
0.924 Intraclass Coefficient (ICC)
|
Adverse Events
Liothyronine (Cytomel)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Liothyronine (Cytomel)
n=10 participants at risk
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.
|
Placebo
n=5 participants at risk
Patient will receive a matching placebo to take twice daily for one week.
|
|---|---|---|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • Number of events 1 • 1 week
|
0.00%
0/5 • 1 week
|
|
Psychiatric disorders
Poor Sleep
|
40.0%
4/10 • 1 week
|
20.0%
1/5 • 1 week
|
|
Gastrointestinal disorders
Loose Stool
|
50.0%
5/10 • Number of events 5 • 1 week
|
0.00%
0/5 • 1 week
|
|
Gastrointestinal disorders
Abdominal Pain
|
10.0%
1/10 • Number of events 1 • 1 week
|
0.00%
0/5 • 1 week
|
|
Cardiac disorders
Tachycardia
|
10.0%
1/10 • Number of events 2 • 1 week
|
20.0%
1/5 • Number of events 7 • 1 week
|
|
Musculoskeletal and connective tissue disorders
Muscle Pain
|
10.0%
1/10 • Number of events 1 • 1 week
|
0.00%
0/5 • 1 week
|
|
Gastrointestinal disorders
Yellow stool
|
10.0%
1/10 • Number of events 1 • 1 week
|
0.00%
0/5 • 1 week
|
|
Skin and subcutaneous tissue disorders
Increased severity in post-Tecfidera flushing
|
10.0%
1/10 • Number of events 1 • 1 week
|
0.00%
0/5 • 1 week
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place