Fluoxetine in Progressive Multiple Sclerosis (FLUOX-PMS): study protocol for a randomized controlled trial

Melissa Cambron*, Jop Mostert, Patrick Haentjens, Marie D'Hooghe, Guy Nagels, Barbara Willekens, Dorothea Heersema, Jan Debruyne, Wim Van Hecke, Luc Algoed, Nina De Klippel, Erwin Fosselle, Guy Laureys, Henri Merckx, Bart Van Wijmeersch, Ludo Vanopdenbosch, Wim Verhagen, Raymond Hupperts, Gerald Hengstman, Veronique MichielsAnnick Van Merhaegen-Wieleman, Jacques De Keyser

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Currently available disease-modifying treatments acting by modifying the immune response are ineffective in progressive multiple sclerosis (MS), which is caused by a widespread axonal degeneration. Mechanisms suspected to be involved in this widespread axonal degeneration are reduced axonal energy metabolism, axonal glutamate toxicity, and reduced cerebral blood flow. Fluoxetine might theoretically reduce axonal degeneration in MS because it stimulates energy metabolism through enhancing glycogenolysis, stimulates the production of brain-derived neurotrophic factor, and dilates cerebral arterioles. The current document presents the protocol of a clinical trial to test the hypothesis that fluoxetine slows down the progressive phase of MS.The FLUOX-PMS trial is a multi-center, randomized, controlled and double-blind clinical study. A total of 120 patients with the diagnosis of either secondary or primary progressive MS will be treated either by fluoxetine (40 mg daily) or placebo for a total period of 108 weeks. The primary endpoint is the time to confirmed disease progression defined as either at least a 20% increase in the timed 25-Foot Walk or at least a 20% increase in the 9-Hole Peg Test. Secondary endpoints include the Hauser ambulation index, cognitive changes, fatigue, magnetic resonance imaging of the brain, and in a small subgroup optical coherence tomography.The FLUOX-PMS trial will gives us information as to whether fluoxetine has neuroprotective effects in patients with progressive MS.Eudra-CT: 2011-003775-11.
Original languageEnglish
Article number37
JournalTrials
Volume15
DOIs
Publication statusPublished - 25 Jan 2014

Keywords

  • Multiple sclerosis
  • Primary progressive
  • Secondary progressive
  • Clinical trial
  • Fluoxetine
  • Neuroprotection

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