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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Liothyronine sodium Drug: Placebo Phase 1

Detailed Description:

This is a pilot, phase I, placebo controlled clinical trial of short-term high-dose thyroid hormone to promote remyelination in MS. Permanent clinical disability in MS is likely caused by the neuronal damage and degeneration that follows recurrent demyelination with progressive failure of remyelination. Thyroid hormone (TH) is required for central nervous system (CNS) myelination during development, and CNS remyelination in animal models of MS, a process similar to developmental myelination, has also been found to be promoted by TH. This study will ascertain the safety, tolerability and maximum tolerated dose of TH in people with MS, explore reliability for a potential signal of treatment efficacy and mechanism, and optimize procedures for a full scale clinical trial to evaluate the efficacy of pulsed TH for promotion of remyelination in MS.

The safety and tolerability of this treatment will be assessed using subjects' self-report of symptoms, the validated Hyperthyroid Symptom Scale (HSS), and blood pressure measurements. a

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
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
Primary Purpose: Treatment
Official Title: Thyroid Hormone for Remyelination in Multiple Sclerosis (MS): A Safety and Dose Finding Study
Actual Study Start Date : June 6, 2016
Actual Primary Completion Date : January 10, 2017
Actual Study Completion Date : January 10, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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
 Drug: 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.
Other Name: Cytomel
Placebo Comparator: Placebo
Subject will take matching placebo twice a day for one week
 Drug: Placebo
Patient will receive a matching placebo to take twice daily for one week.


Outcome Measures
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Primary Outcome Measures :
  1. Determine the Maximum Tolerated Dose (MTD) of Oral L-T3 in Subjects With MS [ Time Frame: 1 week ]
    MTD per protocol (dose level one category below dose at which study was stopped due to intolerance or meeting criteria for cessation)


Secondary Outcome Measures :
  1. Reliability of Visual Evoked Potential (VEP) Testing (ICC) [ Time Frame: 1 week ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02760056


Locations
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United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
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Principal Investigator: Michelle Cameron, MD OHSU Department of Neurology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Michelle Cameron, Chair and Roy & Eulalia Swank Family Research Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02760056    
Other Study ID Numbers: IRB 15101
First Posted: May 3, 2016    Key Record Dates
Results First Posted: November 19, 2018
Last Update Posted: November 19, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Michelle Cameron, Oregon Health and Science University:
Thyroid hormone
Remyelination
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases