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

(2014) TRIALS. 15.
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Abstract
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.
Keywords
DOUBLE-BLIND, ASTROCYTES, Multiple sclerosis, Primary progressive, Secondary progressive, Clinical, trial, Fluoxetine, Neuroprotection

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MLA
Cambron, Melissa, et al. “Fluoxetine in Progressive Multiple Sclerosis (FLUOX-PMS) : Study Protocol for a Randomized Controlled Trial.” TRIALS, vol. 15, 2014.
APA
Cambron, M., Mostert, J., Haentjens, P., D’Hooghe, M., Nagels, G., Willekens, B., … De Keyser, J. (2014). Fluoxetine in Progressive Multiple Sclerosis (FLUOX-PMS) : study protocol for a randomized controlled trial. TRIALS, 15.
Chicago author-date
Cambron, Melissa, Jop Mostert, Patrick Haentjens, Marie D’Hooghe, Guy Nagels, Barbara Willekens, Dorothea Heersema, et al. 2014. “Fluoxetine in Progressive Multiple Sclerosis (FLUOX-PMS) : Study Protocol for a Randomized Controlled Trial.” TRIALS 15.
Chicago author-date (all authors)
Cambron, Melissa, 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 Michiels, Annick Van Merhaegen-Wieleman, and Jacques De Keyser. 2014. “Fluoxetine in Progressive Multiple Sclerosis (FLUOX-PMS) : Study Protocol for a Randomized Controlled Trial.” TRIALS 15.
Vancouver
1.
Cambron M, Mostert J, Haentjens P, D’Hooghe M, Nagels G, Willekens B, et al. Fluoxetine in Progressive Multiple Sclerosis (FLUOX-PMS) : study protocol for a randomized controlled trial. TRIALS. 2014;15.
IEEE
[1]
M. Cambron et al., “Fluoxetine in Progressive Multiple Sclerosis (FLUOX-PMS) : study protocol for a randomized controlled trial,” TRIALS, vol. 15, 2014.
@article{8639868,
  abstract     = {{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.}},
  articleno    = {{37}},
  author       = {{Cambron, Melissa and Mostert, Jop and Haentjens, Patrick and D'Hooghe, Marie and Nagels, Guy and Willekens, Barbara and Heersema, Dorothea and Debruyne, Jan and Van Hecke, Wim and Algoed, Luc and De Klippel, Nina and Fosselle, Erwin and Laureys, Guy and Merckx, Henri and Van Wijmeersch, Bart and Vanopdenbosch, Ludo and Verhagen, Wim and Hupperts, Raymond and Hengstman, Gerald and Michiels, Veronique and Van Merhaegen-Wieleman, Annick and De Keyser, Jacques}},
  issn         = {{1745-6215}},
  journal      = {{TRIALS}},
  keywords     = {{DOUBLE-BLIND,ASTROCYTES,Multiple sclerosis,Primary progressive,Secondary progressive,Clinical,trial,Fluoxetine,Neuroprotection}},
  language     = {{eng}},
  pages        = {{7}},
  title        = {{Fluoxetine in Progressive Multiple Sclerosis (FLUOX-PMS) : study protocol for a randomized controlled trial}},
  url          = {{http://dx.doi.org/10.1186/1745-6215-15-37}},
  volume       = {{15}},
  year         = {{2014}},
}

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