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  • Updated 12.28.2023
  • Released 11.12.2002
  • Expires For CME 12.28.2026

Clinical trials in multiple sclerosis



In this article, the author discusses the basics of multiple sclerosis clinical trial design. Data on the treatment of relapses and current FDA-approved disease-modifying therapies are reviewed.

Key points

• There are currently 20 FDA-approved disease-modifying therapies available for the treatment of relapsing-remitting multiple sclerosis.

• Subsequent approvals for relapsing-remitting multiple sclerosis have included the oral therapies monomethyl fumarate, ozanimod, and ponesimod; the infusion therapy ublituximab; and the subcutaneous injection therapy, ofatumumab.

• The first clinical trials for the treatment of radiologically isolated syndrome (with dimethyl fumarate and teriflunomide) were reported in 2023.

• Treatment of progressive disease remains challenging. Only ocrelizumab is approved for primary progressive multiple sclerosis.

• BTK inhibitors are the most active area of current therapeutic development, with multiple ongoing phase III trials for both progressive and relapsing disease.

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ISSN: 2831-9125