Five-year results from a phase 2 study of oral fingolimod in relapsing multiple sclerosis

Mult Scler. 2014 Jun;20(7):877-81. doi: 10.1177/1352458513513059. Epub 2013 Nov 30.

Abstract

We present here results at 60 months (M), from the extension component of a phase 2, randomized, placebo-controlled, double-blind, six-month study evaluating oral fingolimod (1.25 mg or 5 mg daily) in relapsing multiple sclerosis. Placebo patients from the core study were re-randomized to fingolimod 1.25 mg or 5 mg in the extension. All patients received 1.25 mg fingolimod after the M24 visit. A total of 140/281 (49.8%) patients completed M60. Fingolimod treatment was associated with a low annualized relapse rate (0.2 relapses/ year), low MRI activity, and a modest rate of disability progression in those treated for five years. No new safety issues were reported.

Trial registration: ClinicalTrials.gov NCT00785083.

Keywords: Fingolimod; disease-modifying therapy; long term; phase 2; relapsing–remitting multiple sclerosis; sphingosine 1-phosphate receptor modulator.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Disability Evaluation
  • Disease Progression
  • Double-Blind Method
  • Fingolimod Hydrochloride / administration & dosage*
  • Fingolimod Hydrochloride / adverse effects
  • Humans
  • Immunosuppressive Agents / administration & dosage*
  • Immunosuppressive Agents / adverse effects
  • Magnetic Resonance Imaging
  • Multiple Sclerosis, Relapsing-Remitting / diagnosis
  • Multiple Sclerosis, Relapsing-Remitting / drug therapy*
  • Multiple Sclerosis, Relapsing-Remitting / immunology
  • Time Factors
  • Treatment Outcome

Substances

  • Immunosuppressive Agents
  • Fingolimod Hydrochloride

Associated data

  • ClinicalTrials.gov/NCT00785083