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Fluoxetine in progressive multiple sclerosis (FLUOX-PMS): study protocol for a randomized controlled trial
Melissa Cambron1, Jop Mostert, Patrick Haentjens
1Department of Neurology, University Hospital Brussel, Center for Neurosciences Vrije Universiteit Brussel (VUB) UZ Brussel, Laarbeeklaan 101, 1090 Brussels, Belgium. melissa.cambron@gmail.com.
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.
Insights
This clinical trial investigates if fluoxetine can slow progressive multiple sclerosis (MS) by potentially protecting axons. Researchers will assess fluoxetine
Area of Science:
- Neuroscience
- Clinical Neurology
- Pharmacology
Background:
- Current disease-modifying treatments are ineffective for progressive multiple sclerosis (MS), a condition characterized by widespread axonal degeneration.
- Suspected mechanisms in MS axonal degeneration include impaired energy metabolism, glutamate toxicity, and reduced cerebral blood flow.
- Fluoxetine may offer neuroprotection in MS by stimulating axonal energy metabolism, promoting brain-derived neurotrophic factor, and dilating cerebral arterioles.
Purpose of the Study:
- To test the hypothesis that fluoxetine can slow the progression of MS.
- To evaluate the potential neuroprotective effects of fluoxetine in progressive MS patients.
Main Methods:
- The FLUOX-PMS trial is a multi-center, randomized, double-blind, placebo-controlled study.
- 120 patients with secondary or primary progressive MS will receive either 40 mg of fluoxetine daily or a placebo for 108 weeks.
- Primary endpoint: time to confirmed disease progression (20% increase in 25-Foot Walk or 9-Hole Peg Test); secondary endpoints include ambulation, cognition, fatigue, and imaging.
Main Results:
- Results are pending as the trial is designed to gather information on fluoxetine's efficacy.
- The study will provide data on fluoxetine's impact on key MS progression markers.
Conclusions:
- The FLUOX-PMS trial aims to determine if fluoxetine exhibits neuroprotective properties in progressive MS.
- Findings will inform potential new therapeutic strategies for progressive MS.
