Fluoxetine in progressive multiple sclerosis (FLUOX-PMS): study protocol for a
randomized controlled trial.
Author(s): Cambron M(1), Mostert J, Haentjens P, D'Hooghe M, Nagels G, Willekens B, Heersema
D, Debruyne J, Van Hecke W, Algoed L, De Klippel N, Fosselle E, Laureys G, Merckx
H, Van Wijmeersch B, Vanopdenbosch L, Verhagen W, Hupperts R, Hengstman G,
Michiels V, Van Merhaegen-Wieleman A, De Keyser J.
Affiliation(s): Author information:
(1)Department of Neurology, University Hospital Brussel, Center for Neurosciences
Vrije Universiteit Brussel (VUB) UZ Brussel, Laarbeeklaan 101, 1090 Brussels,
Belgium. melissa.cambron@gmail.com.
Publication date & source: 2014, Trials. , 15:37
BACKGROUND: 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.
METHODS/DESIGN: 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.
DISCUSSION: The FLUOX-PMS trial will gives us information as to whether
fluoxetine has neuroprotective effects in patients with progressive MS.
TRIAL REGISTRATION: Eudra-CT: 2011-003775-11.
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