Contributions
Abstract: 253
Type: LB Oral
Abstract Category: Late Breaking News
Background: The progressive phase of multiple sclerosis (MS) is characterized by a widespread axonal degeneration, which leads to a substantial disability in patients and up-to-date the currently available disease-modifying treatments fail to stop this degenerative process. Since these immunomodulatory treatments do not seem to slow down this process, we suspect that a reduced axonal energy metabolism, axonal glutamate toxicity and reduced cerebral blood flow are involved in this widespread axonal degeneration. Fluoxetine has shown to have neuroprotective features and might theoretically reduce axonal degeneration through stimulation of the energy metabolism by enhancing glycogenolysis, increasing the production of Brain Derived Neurotrophic Factor, and dilating cerebral arterioles. This clinical trial aims 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. Hundred and thirty-four patients with the diagnosis of either secondary or primary progressive MS were treated either by fluoxetine (40 mg daily) or placebo for a total period of 108 weeks. The primary endpoint was 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. Trial Registration Eudra-CT: 2011-003775-11.
Results: Overall 180 patients were screened of whom 134 were randomized to fluoxetine or placebo. Mean age at baseline was 53 years. In total 47,2% of the included patients were female, 24,8% were on classic disease modifying treatment for MS. 38,5% of the patients were diagnosed with a primary progressive form of MS.
Discussion: The results of the FLUOX-PMS trial will allow us to assess whether fluoxetine has neuroprotective effects in patients with progressive MS. The results will be presented after all the patients have finished the trial, which is expected by the end of July 2016.
Disclosure:
Melissa Cambron: nothing to disclose
Jop Mostert: nothing to disclose
Jose Parra: nothing to disclose
Marie D"Hooghe: nothing to disclose
Guy Nagels: nothing to disclose
Barbara Willekens: nothing to disclose
Dorothea Heersema: nothing to disclose
Jan Debruyne: nothing to disclose
Wim Van Hecke: nothing to disclose
Luc Algoed: nothing to disclose
Nina De Klippel: nothing to disclose
Erwin Fosselle: nothing to disclose
Guy Laureys: nothing to disclose
Henri Merckx: nothing to disclose
Bart Van Wijmeersch: nothing to disclose
Ludo Vanopdenbosch: nothing to disclose
Wim Verhaegen: nothing to disclose
Raymond Hupperts: nothing to disclose
Gerald Hengstman: nothing to disclose
Veronique Michiels: nothing to disclose
Annick Van Merhaegen-Wieleman: nothing to disclose
Jacques De Keyser: nothing to disclose
Abstract: 253
Type: LB Oral
Abstract Category: Late Breaking News
Background: The progressive phase of multiple sclerosis (MS) is characterized by a widespread axonal degeneration, which leads to a substantial disability in patients and up-to-date the currently available disease-modifying treatments fail to stop this degenerative process. Since these immunomodulatory treatments do not seem to slow down this process, we suspect that a reduced axonal energy metabolism, axonal glutamate toxicity and reduced cerebral blood flow are involved in this widespread axonal degeneration. Fluoxetine has shown to have neuroprotective features and might theoretically reduce axonal degeneration through stimulation of the energy metabolism by enhancing glycogenolysis, increasing the production of Brain Derived Neurotrophic Factor, and dilating cerebral arterioles. This clinical trial aims 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. Hundred and thirty-four patients with the diagnosis of either secondary or primary progressive MS were treated either by fluoxetine (40 mg daily) or placebo for a total period of 108 weeks. The primary endpoint was 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. Trial Registration Eudra-CT: 2011-003775-11.
Results: Overall 180 patients were screened of whom 134 were randomized to fluoxetine or placebo. Mean age at baseline was 53 years. In total 47,2% of the included patients were female, 24,8% were on classic disease modifying treatment for MS. 38,5% of the patients were diagnosed with a primary progressive form of MS.
Discussion: The results of the FLUOX-PMS trial will allow us to assess whether fluoxetine has neuroprotective effects in patients with progressive MS. The results will be presented after all the patients have finished the trial, which is expected by the end of July 2016.
Disclosure:
Melissa Cambron: nothing to disclose
Jop Mostert: nothing to disclose
Jose Parra: nothing to disclose
Marie D"Hooghe: nothing to disclose
Guy Nagels: nothing to disclose
Barbara Willekens: nothing to disclose
Dorothea Heersema: nothing to disclose
Jan Debruyne: nothing to disclose
Wim Van Hecke: nothing to disclose
Luc Algoed: nothing to disclose
Nina De Klippel: nothing to disclose
Erwin Fosselle: nothing to disclose
Guy Laureys: nothing to disclose
Henri Merckx: nothing to disclose
Bart Van Wijmeersch: nothing to disclose
Ludo Vanopdenbosch: nothing to disclose
Wim Verhaegen: nothing to disclose
Raymond Hupperts: nothing to disclose
Gerald Hengstman: nothing to disclose
Veronique Michiels: nothing to disclose
Annick Van Merhaegen-Wieleman: nothing to disclose
Jacques De Keyser: nothing to disclose