Open-label Study of Liothyronine in MS
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Liothyronine
Thyroid hormone receptor agonist
What it measured
Main measures
The incidence rate of adverse events
26 weeks
Safety
Who could take part
Relapsing and progressive · 18 to 58
Inclusion Criteria: * 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 Exclusion Criteria: * 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
A Phase 1b, Open-Label Study to Evaluate the Safety and Tolerability of the Putative Remyelinating Agent, Liothyronine, in Individuals with MS.Neurotherapeutics · 2023
Background
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.Background
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.Background
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.Background
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.Background
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.Background
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.Background
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.Background
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.Background
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.
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History
Started
Jul 2015
Main results due
Sept 2017
Finished
Sept 2017
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