NCT02506751

Brief Summary

This study will evaluate the safety and tolerability of synthetic T3, liothyronine. It will establish if there are changes in MS symptoms and if there is a positive effect on markers of neuronal health.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 23, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2017

Completed
Last Updated

February 12, 2018

Status Verified

February 1, 2018

Enrollment Period

2.2 years

First QC Date

July 12, 2015

Last Update Submit

February 8, 2018

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple Sclerosis, Secondary ProgressiveMultiple Sclerosis, Primary Progressive

Outcome Measures

Primary Outcomes (1)

  • The incidence rate of adverse events

    26 weeks

Study Arms (1)

Liothyronine

EXPERIMENTAL

Subjects will take oral liothyronine for a total of 24 weeks following the below titration schedule: 0-6 weeks: liothyronine 10mcg po daily (5mcg po BID) 6-12 weeks: liothyronine 20mcg po daily (10mcg po BID) 12-18 weeks: liothyronine 50mcg po daily (25mcg po BID) 18-24 weeks: liothyronine 1mcg/kg/day (0.5mcg/kg po BID), not to exceed 75mcg po daily

Drug: liothyronine

Interventions

liothyronineDRUG

All eligible subjects will be treated with the study drug as per the standardized dose-escalation protocol. Subjects will be required to report to the study site every six weeks for the duration of the study in order to receive their study drug and to monitor drug safety and tolerability.

Also known as: Cytomel
Liothyronine

Eligibility Criteria

Age18 Years - 58 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Must meet 2010 McDonald criteria for clinically definite MS
  • Must be euthyroid
  • Expanded Disability Status Scale (EDSS) 3.0-7.5
  • Patients may be on MS immunomodulating therapies or immunosuppressant therapies during the study

You may not qualify if:

  • Known thyroid disease (past or current)
  • Currently on thyroid replacement therapy
  • Steroid use within a month of screening
  • History of coronary artery disease, atrial fibrillation, or other clinically significant cardiac disease
  • History of adrenal insufficiency
  • Ongoing renal and/or liver disease
  • Ongoing severe depression and/or anxiety
  • Use of carbamazepine, phenytoin, phenobarbital, warfarin, antacids, cholestyramine, colestipol, sucralfate, and rifampin
  • Known contraindication to using beta-blocker medications
  • History of alcohol or substance abuse in the past 6 months
  • Pregnant or nursing
  • If the investigator feels that participation in this study is not in the best interest of the subject

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (9)

  • Karampampa K, Gustavsson A, Miltenburger C, Eckert B. Treatment experience, burden and unmet needs (TRIBUNE) in MS study: results from five European countries. Mult Scler. 2012 Jun;18(2 Suppl):7-15. doi: 10.1177/1352458512441566.

    PMID: 22623122BACKGROUND

  • Orme M, Kerrigan J, Tyas D, Russell N, Nixon R. The effect of disease, functional status, and relapses on the utility of people with multiple sclerosis in the UK. Value Health. 2007 Jan-Feb;10(1):54-60. doi: 10.1111/j.1524-4733.2006.00144.x.

    PMID: 17261116BACKGROUND

  • Scott TF, Schramke CJ. Poor recovery after the first two attacks of multiple sclerosis is associated with poor outcome five years later. J Neurol Sci. 2010 May 15;292(1-2):52-6. doi: 10.1016/j.jns.2010.02.008. Epub 2010 Mar 4.

    PMID: 20202650BACKGROUND

  • Sormani MP, Li DK, Bruzzi P, Stubinski B, Cornelisse P, Rocak S, De Stefano N. Combined MRI lesions and relapses as a surrogate for disability in multiple sclerosis. Neurology. 2011 Nov 1;77(18):1684-90. doi: 10.1212/WNL.0b013e31823648b9. Epub 2011 Oct 5.

    PMID: 21975200BACKGROUND

  • Mowry EM, Pesic M, Grimes B, Deen S, Bacchetti P, Waubant E. Demyelinating events in early multiple sclerosis have inherent severity and recovery. Neurology. 2009 Feb 17;72(7):602-8. doi: 10.1212/01.wnl.0000342458.39625.91.

    PMID: 19221292BACKGROUND

  • Chang A, Tourtellotte WW, Rudick R, Trapp BD. Premyelinating oligodendrocytes in chronic lesions of multiple sclerosis. N Engl J Med. 2002 Jan 17;346(3):165-73. doi: 10.1056/NEJMoa010994.

    PMID: 11796850BACKGROUND

  • Witte ME, Bo L, Rodenburg RJ, Belien JA, Musters R, Hazes T, Wintjes LT, Smeitink JA, Geurts JJ, De Vries HE, van der Valk P, van Horssen J. Enhanced number and activity of mitochondria in multiple sclerosis lesions. J Pathol. 2009 Oct;219(2):193-204. doi: 10.1002/path.2582.

    PMID: 19591199BACKGROUND

  • van Horssen J, Witte ME, Ciccarelli O. The role of mitochondria in axonal degeneration and tissue repair in MS. Mult Scler. 2012 Aug;18(8):1058-67. doi: 10.1177/1352458512452924. Epub 2012 Jun 21.

    PMID: 22723572BACKGROUND

  • Harsan LA, Steibel J, Zaremba A, Agin A, Sapin R, Poulet P, Guignard B, Parizel N, Grucker D, Boehm N, Miller RH, Ghandour MS. Recovery from chronic demyelination by thyroid hormone therapy: myelinogenesis induction and assessment by diffusion tensor magnetic resonance imaging. J Neurosci. 2008 Dec 24;28(52):14189-201. doi: 10.1523/JNEUROSCI.4453-08.2008.

    PMID: 19109501BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple Sclerosis, Chronic Progressive

Interventions

Triiodothyronine

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThyroninesThyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsThyroxineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Scott Newsome, DO

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2015

First Posted

July 23, 2015

Study Start

July 1, 2015

Primary Completion

September 18, 2017

Study Completion

September 18, 2017

Last Updated

February 12, 2018

Record last verified: 2018-02

Locations

US(1)