Minocycline in a Clinically Isolated Syndrome of Multiple Sclerosis



Title: Trial of Minocycline in a Clinically Isolated Syndrome of Multiple Sclerosis

Metz, L.M. et al.


 

What You Need to Know:

Compared to placebo, minocycline significantly decreased the risk of conversion from a clinically isolated syndrome (or the first demyelinating event) to multiple sclerosis (MS) over 6, but not over 24, months.

Trial Design:

  • Multicenter, randomized, placebo-controlled trial evaluating the effect of minocycline on the risk of conversion from a first demyelinating event to MS
  • 142 patients with their first demyelinating symptoms occurring within the past 180 days were randomized to receive 100mg oral minocycline twice daily (n=72) or placebo (n=70) until either MS was diagnosed or 24 months after randomization
  • Primary endpoint: conversion to MS within 6 months of randomization
  • Secondary endpoints: conversion to MS within 24 months of randomization, magnetic resonance imaging (MRI) changes at 6 and 24 months

Key Outcomes:

  • Risk of conversion to MS within 6 months of randomization (unadjusted): 61.0% for placebo patients, 33.4% for minocycline patients (27.6% difference; 95% CI: 11.4, 43.9; P=0.001)
  • 18.5% difference in the risk of conversion to MS within 6 months of randomization was calculated after adjusting for enhancing lesions at baseline (95% CI: 3.7, 33.3; P=0.01)
  • Unadjusted difference in the risk of conversion to MS within 24 months of randomization was not significant
  • MRI outcomes favored minocycline at 6 months only
  • Trial withdrawals and adverse events more common in minocycline group (rash, dizziness, dental discoloration)