Thyroid Hormone for Remyelination in Multiple Sclerosis (MS): A Safety and Dose Finding Study
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Liothyronine sodium; Placebo
Intervention description: 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.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Dose escalation with monitoring for safety and tolerability, as well as reliability of VEP testing.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blind, randomized, controlled
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Thyroid hormone; Remyelination

Summary:

      This is a phase 1 study evaluating the safety and maximum tolerated dose of Liothyronine (T3)
      in subjects with multiple sclerosis
    

Eligibility criteria:

        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)