Trials · 2014
Fluoxetine in progressive multiple sclerosis (FLUOX-PMS): study protocol for a randomized controlled trial.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Cambron Melissa, Mostert Jop, Haentjens Patrick, D'Hooghe Marie, Nagels Guy, Willekens Barbara, Heersema Dorothea, Debruyne Jan, Van Hecke Wim, Algoed Luc, De Klippel Nina, Fosselle Erwin, Laureys Guy, Merckx Henri, Van Wijmeersch Bart, Vanopdenbosch Ludo, Verhagen Wim, Hupperts Raymond, Hengstman Gerald, Michiels Veronique, Van Merhaegen-Wieleman Annick, De Keyser Jacques
Аннотация
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.
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.
Предметные рубрики MeSH
AdultAgedBelgiumBrainClinical ProtocolsCognitionDisability EvaluationDisease ProgressionDouble-Blind MethodFemaleFluoxetineHumansMagnetic Resonance ImagingMaleMiddle AgedMultiple Sclerosis, Chronic ProgressiveNerve DegenerationNetherlandsNeuroprotective AgentsNeuropsychological TestsRadiographyResearch DesignTime FactorsTomography, Optical CoherenceTreatment Outcome