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Related Experiment Video

Updated: Jul 4, 2025

Experimental Demyelination and Remyelination of Murine Spinal Cord by Focal Injection of Lysolecithin
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Measuring and predicting the effect of remyelinating therapy in multiple sclerosis: a randomised controlled trial

Sam Hof1, Laurentius J van Rijn2,3, Bernard M J Uitdehaag4

  • 1MS Center and Neuro-ophthalmology Expertise Center Amsterdam, Amsterdam UMC Location VUmc, Amsterdam, Noord-Holland, The Netherlands s.n.hof@amsterdamumc.nl.

BMJ Open
|January 31, 2024
PubMed
Summary

This study investigates clemastine fumarate for multiple sclerosis (MS) remyelination, using internuclear ophthalmoplegia (INO) and infrared oculography. Fampridine may predict treatment response in MS patients.

Keywords:
Multiple sclerosisNeuro-ophthalmologyNeurophysiologyRandomized Controlled TrialTHERAPEUTICS

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Area of Science:

  • Neuroscience
  • Clinical Trials
  • Pharmacology

Background:

  • Remyelination failure in multiple sclerosis (MS) hinders recovery, necessitating novel therapeutic strategies.
  • Current remyelination assessment in MS trials primarily relies on optic neuritis, requiring more generalizable methods.
  • Internuclear ophthalmoplegia (INO) measured by infrared oculography offers a complementary, generalizable approach to assess remyelination in MS.

Purpose of the Study:

  • To investigate the long-term remyelinating effects of clemastine fumarate in MS patients with INO.
  • To evaluate the predictive potential of fampridine response for clemastine treatment efficacy in MS.
  • To establish infrared oculography as a method for measuring remyelination in MS clinical trials.

Main Methods:

  • RESTORE trial: a single-center, double-blind, randomized placebo-controlled study.
  • Participants with MS and INO randomized to clemastine fumarate (4mg BID for 6 months) or placebo.
  • Fampridine response predicts clemastine efficacy; primary outcome is Versional Dysconjugacy Index improvement via infrared oculography.

Main Results:

  • Primary outcome: improvement in Versional Dysconjugacy Index-area under the curve after 6 months of clemastine treatment.
  • Secondary outcomes: other oculography parameters, retinal imaging, visual acuity, disability, cognition, and patient-reported outcomes.
  • Long-term follow-up at 6, 18, and 30 months post-treatment to assess persistent effects.

Conclusions:

  • Clemastine fumarate shows potential for remyelination in MS patients with INO.
  • Fampridine response may identify individuals likely to benefit from clemastine treatment.
  • Infrared oculography provides a valuable, generalizable tool for assessing remyelination in MS clinical trials.