MST3K
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Liothyronine
Thyroid hormone receptor agonist
Placebo or sham
- Placebo
Results by group
Determine the Maximum Tolerated Dose (MTD) of Oral L-T3 in Subjects With MS
1 week
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Liothyronine (Cytomel) | 75 mcg daily with BID dosing | 10 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Liothyronine (Cytomel) | 10 | 0 (0.0%) | 0 |
| Placebo | 5 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Determine the Maximum Tolerated Dose (MTD) of Oral L-T3 in Subjects With MS
1 week
Other measures (1)
Reliability of Visual Evoked Potential (VEP) Testing (ICC)
1 week
Myelin repair
Who could take part
MS (type not specified) · 18 to 50
Inclusion Criteria: * Confirmed diagnosis of MS of any type * Age 18 to 50 years * Weight range 45-90 kg (100-200 lbs) * Lesions on brain MRI Exclusion Criteria: * History of hypo or hyperthyroidism and a normal TSH * History of high blood pressure (hypertension) [ * Resting blood pressure greater than 150/95, resting heart rate greater than 100 * History of coronary artery disease or clinically significant arrhythmia, clinically significant abnormalities on EKG * History of diabetes * History of anemia or renal (kidney) disease * Clinically significant abnormalities on metabolic panel or serum hematocrit below 32 % * History of atrophic gastritis * History of anxiety disorder or bipolar disorder * Serious psychiatric or medical conditions that would preclude reliable participation in the study * Use of illicit substances or alcohol abuse * Current use of fingolimod (Gilenya) * Current or prior use of mitoxantrone (Novantrone) * Current use of stimulants (methylphenidate, atomoxetine, dextroamphetamine,phentermine) * Current use of any blood thinners such as warfarin or apixaban (Aspirin is ok) * Medications which would metabolized faster in the presence of thyroid hormone (Insulin, oral hypoglycemic agents and oral anticoagulants) * Severe head tremors (which would impair the ability to perform VEPs) * Present or recent use of medications that could interact with the thyroid hormone (iodine containing agents such as kelp supplements, amiodarone, iodinated contrast given for CT or xray), P450 stimulants (phenytoin, carbamazepine, phenobarbital, and rifampin) * Corrected visual acuity worse than 20/50 in either eye or other eye issues that would prevent reading of a standard eye chart * Head tremors or other tremors that would prevent sitting relatively still for a vision test * Patients taking proton pump inhibitors (PPIs) or H2 blockers will be excluded unless they can safely not take these medications during the week of study drug administration. * Patients taking Ampyra (dalfampridine) will be excluded unless they can safely not take these medications during the week of study drug administration. * Pregnancy, breastfeeding, or intention to become pregnant in the following month * Inability to receive an MRI (e.g. implanted metal device)
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This is a phase 1 study evaluating the safety and maximum tolerated dose of Liothyronine (T3) in subjects with multiple sclerosis
Papers
Loading reviews and guidelines…
Related trials
- RESTORE
Phase 3 · Stopped early
Stopped: not working
- PET Study to Determine the Relationship Between Plasma Co…
Phase 1 · Completed
No result found
- Phase I Study Evaluating Safety and Tolerability of Escal…
Phase 1 · Completed
No result found
- Pharmacokinetics, Safety and Tolerability of Single Doses…
Phase 1 · Completed
No result found
- Safety, Tolerability, and Pharmacokinetics of Single and …
Phase 1 · Completed
No result found
- GSK239512 DDI Study
Phase 1 · Completed
No result found
History
Started
Jun 2016
Main results due
Jan 2017
Finished
Jan 2017
Results posted
Nov 2018
Assembled by software from public sources and not checked by people. Each record links to its source. Report an error