CompletedPhase 1MS (type not specified)NCT02760056

What it found

Results posted, no main test reported

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

GroupValueIntervalNumber analysed
Liothyronine (Cytomel)75 mcg daily with BID dosing10

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Liothyronine (Cytomel)100 (0.0%)0
Placebo50 (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

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Related trials

History

    1. Started

      Jun 2016

    2. Main results due

      Jan 2017

    3. Finished

      Jan 2017

    4. Results posted

      Nov 2018

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