Fluoxetine in Progressive Multiple Sclerosis (FLUOX-PMS): study protocol for a randomized controlled trial
1 Department of Neurology, University Hospital Brussel, Center for Neurosciences Vrije Universiteit Brussel (VUB) UZ Brussel, Laarbeeklaan 101, 1090 Brussels, Belgium
2 Department of Neurology, Rijnstate Hospital, Arnhem, The Netherlands
3 Centre for Outcomes Research and Laboratory for Experimental Surgery, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Laarbeeklaan 101, B 1090 Brussels, Belgium
4 Department of Neurology, National MS Center Melsbroek, Brussels, Belgium
5 Department of Neurology, Antwerp University Hospital, Antwerp, Belgium
6 Department of Neurology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands
7 Department of Neurology, University Hospital Ghent, Ghent, Belgium
8 Icometrix, Leuven, Belgium
9 Department of Neurology, AZ Maria Middelares, Ghent, Belgium
10 Department of Neurology, Jessa Hospital, Hasselt, Belgium
11 Department of Neurology, ASZ Aalst, Aalst, Belgium
12 Department of Neurology, Maria Hospital, Halle, Belgium
13 Department of Neurology, H.-Hartziekenhuis, Menen, Belgium
14 Department of Neurology, MS centre, Overpelt, Belgium
15 Department of Neurology, AZ St. Jan, Brugge, Belgium
16 Department of Neurology, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands
17 Department of Neurology, Orbis Medisch Centrum, Sittard, The Netherlands
18 Department of Neurology, Catharina Ziekenhuis, Eindhoven, The Netherlands
Trials 2014, 15:37 doi:10.1186/1745-6215-15-37Published: 25 January 2014
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.
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.
The FLUOX-PMS trial will gives us information as to whether fluoxetine has neuroprotective effects in patients with progressive MS.