@article{372d8f8c3e5f4321bdcbea7f1c5f65d7,
title = "Fluoxetine in progressive multiple sclerosis: The FLUOX-PMS trial",
abstract = "Background: Preclinical studies suggest that fluoxetine has neuroprotective properties that might reduce axonal degeneration in multiple sclerosis (MS). Objective: To determine whether fluoxetine slows accumulation of disability in progressive MS. Methods: In a double-blind multicenter phase 2 trial, patients with primary or secondary progressive MS were randomized to fluoxetine 40 mg/day or placebo for a period of 108 weeks. Clinical assessments were performed every 12 weeks by trained study nurses who visited the patients at their home. The primary outcome was the time to a 12-week confirmed 20% increase in the Timed 25 Foot Walk or 9-Hole Peg test. Secondary outcomes included the Hauser ambulation index, cognitive tests, fatigue, and brain magnetic resonance imaging (MRI). Results: In the efficacy analysis, 69 patients received fluoxetine and 68 patients received placebo. Using the log-rank test (p = 0.258) and Cox regression analysis (p = 0.253), we found no significant difference in the primary outcome between the two groups. Due to an unexpected slow rate of progression in the placebo group, there was insufficient statistical power to detect a potential benefit of fluoxetine. We found no differences between the two groups for secondary outcomes. Conclusion: The trial failed to demonstrate a neuroprotective effect of fluoxetine in patients with progressive MS.",
keywords = "Multiple sclerosis, progressive multiple sclerosis, clinical trial, fluoxetine, outcome, neuroprotection, EXPERIMENTAL AUTOIMMUNE ENCEPHALOMYELITIS, DOUBLE-BLIND",
author = "Melissa Cambron and Jop Mostert and Marie D'Hooghe and Guy Nagels and Barbara Willkens and Jan Debruyne and Luc Algoed and Winn Verhagen and Raymond Hupperts and Dorothea Heersema and {De Keyser}, Jacques and {De Groot}, Liesbeth and Erwin Foselle and Daniel Guillaume and Henri Merckx and Ludo Vanopdenbosch and Mathieu Vokaer and {De Klippel}, Nina and Dirk Nuytten and {Van Remoortel}, Ann and Anoek Symons and Miguel D'haeseleer and Veronique Bissay and {Van Merhaegen-Wieleman}, Annick and {Van Lint}, Michel and Veronique Michiels and Patrick Haentjens and {Van Wijmeersch}, Bart and Bart Tillemans and {Van Hecke}, Wim and Gerald Hengstman and {FLUOX-PMS Study Group}",
note = "Funding Information: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The study was funded by IWT (Agentschap voor Innovatie door Wetenschap en Technologie, Belgium; TBM-IWT project 100772); additional financial support for the Dutch participants was provided by MS Anders (Amsterdam, The Netherlands). Funding Information: We thank the study nurses from Brunel who visited the patients at their home; Jos? Para and Kurt Barb? for statistical advice; Thibo Billiet, Lene Claes, and Annemie Ribbens (Icometrix, Leuven, Belgium) for analysis of the brain MRI data; Eurogenerics (Brussel, Belgium) for providing the study medication (fluoxetine and placebo) at an academic price; and MS Anders for their support in the recruitment of Dutch patients (Amsterdam, The Netherlands). M.C. and J.M. contributed equally to this article. The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The study was funded by IWT (Agentschap voor Innovatie door Wetenschap en Technologie, Belgium; TBM-IWT project 100772); additional financial support for the Dutch participants was provided by MS Anders (Amsterdam, The Netherlands). Publisher Copyright: {\textcopyright} The Author(s), 2019.",
year = "2019",
month = nov,
doi = "10.1177/1352458519843051",
language = "English",
volume = "25",
pages = "1728--1735",
journal = "Multiple Sclerosis Journal",
issn = "1352-4585",
publisher = "SAGE Publications Ltd",
number = "13",
}