Presented at the annual ECTRIMS conference in London, September 17, 2016, in the "Late Breaking News" category:
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Fluoxetine in progressive multiple sclerosis (FLUOX-PMS)
M. Cambron1, J. Mostert2, J. Parra3, M. D'hooghe4, G. Nagels4, B. Willekens5, D. Heersema6, J. Debruyne7, W. Van Hecke8, L. Algoed9, N. De Klippel10, E. Fosselle11, G. Laureys12, H. Merckx13, B. Van Wijmeersch14, L. Vanopdenbosch15, W. Verhaegen16, R. Hupperts17, G. Hengstman18, V. Michiels1, A. Van Merhaegen - Wieleman1, J. De Keyser1,6
1University Hospital Brussels, Brussels, Belgium, 2Rijnstate Hospital, Arnhem, The Netherlands, 3UMCOM, Vrije Universiteit Brussel, Brussels, 4National MS Center Melsbroek, Melsbroek, 5Antwerp University Hospital, Antwerp, Belgium, 6University Medical Center Groningen, Groningen, The Netherlands, 7University Hospital Ghent, Ghent, 8Icometrix, Leuven, 9AZ Marie Middelares Ghent, Ghent, 10Jessa Ziekenhuizen, Hasselt, 11ASZ Aalst, Aalst, 12Maria Hospital, Halle, 13Heilig Hartziekenhuis, Menen, 14MS Centre Overpelt, Overpelt, 15AZ Sint-Jan, Brugge, Belgium, 16Canisius Wilhelmina Hospital, Nijmegen, 17Orbis Medical Center, Sittard, 18Catharina Hospital, Eindhoven, The Netherlands
Background:
The progressive phase of multiple sclerosis (MS) is characterized by a widespread axonal degeneration, which leads to a substantial disability in patients and [so far] the currently available disease-modifying treatments [have failed] 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 [Prozac] has [been] 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. 134 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:
None of the authors had anything to disclose.
There is also this report in MedPage Today, "Fluoxetine flops as progressive MS therapy":
Only registered and activated users can see links., Click Here To Register...
M. Cambron1, J. Mostert2, J. Parra3, M. D'hooghe4, G. Nagels4, B. Willekens5, D. Heersema6, J. Debruyne7, W. Van Hecke8, L. Algoed9, N. De Klippel10, E. Fosselle11, G. Laureys12, H. Merckx13, B. Van Wijmeersch14, L. Vanopdenbosch15, W. Verhaegen16, R. Hupperts17, G. Hengstman18, V. Michiels1, A. Van Merhaegen - Wieleman1, J. De Keyser1,6
1University Hospital Brussels, Brussels, Belgium, 2Rijnstate Hospital, Arnhem, The Netherlands, 3UMCOM, Vrije Universiteit Brussel, Brussels, 4National MS Center Melsbroek, Melsbroek, 5Antwerp University Hospital, Antwerp, Belgium, 6University Medical Center Groningen, Groningen, The Netherlands, 7University Hospital Ghent, Ghent, 8Icometrix, Leuven, 9AZ Marie Middelares Ghent, Ghent, 10Jessa Ziekenhuizen, Hasselt, 11ASZ Aalst, Aalst, 12Maria Hospital, Halle, 13Heilig Hartziekenhuis, Menen, 14MS Centre Overpelt, Overpelt, 15AZ Sint-Jan, Brugge, Belgium, 16Canisius Wilhelmina Hospital, Nijmegen, 17Orbis Medical Center, Sittard, 18Catharina Hospital, Eindhoven, The Netherlands
Background:
The progressive phase of multiple sclerosis (MS) is characterized by a widespread axonal degeneration, which leads to a substantial disability in patients and [so far] the currently available disease-modifying treatments [have failed] 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 [Prozac] has [been] 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. 134 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:
None of the authors had anything to disclose.
There is also this report in MedPage Today, "Fluoxetine flops as progressive MS therapy":
Only registered and activated users can see links., Click Here To Register...
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