Fluoxetine in progressive multiple sclerosis: The FLUOX-PMS trial. (November 2019)

• Record Type: Journal Article
• Authors: Cambron, Melissa; Mostert, Jop; D'Hooghe, Marie; Nagels, Guy; Willekens, Barbara; Debruyne, Jan; Algoed, Luc; Verhagen, Wim; Hupperts, Raymond; Heersema, Dorothea; De Keyser, Jacques
• Other Names: De Groot Liesbeth non-byline-author.; De Bruyne Jan non-byline-author.; Foselle Erwin non-byline-author.; Guillaume Daniel non-byline-author.; Merckx Henri non-byline-author.; Vanopdenbosch Ludo non-byline-author.; Vokaer Mathieu non-byline-author.; Klippel Nina De non-byline-author.; Nuytten Dirk non-byline-author.; Van Remoortel Ann non-byline-author.; Symons Anoek non-byline-author.; D'haeseleer Miguel non-byline-author.; Bissay Veronique non-byline-author.; Van Merhaegen-Wieleman Annick non-byline-author.; Van Lint Michel non-byline-author.; Michiels Veronique non-byline-author.; Haentjens Patrick non-byline-author.; Van Wijmeersch Bart non-byline-author.; Tillemans Bart non-byline-author.; Van Hecke Wim non-byline-author.; Hengstman Gerald non-byline-author.
• Is Part Of: Multiple sclerosis. Volume 25:Number 13(2019)
• Page Start: 1728
• Page End: 1735
• Publication Date: 2019-11
• Subjects: Multiple sclerosis -- progressive multiple sclerosis -- clinical trial -- fluoxetine -- outcome -- neuroprotection; Central nervous system -- Diseases -- Periodicals; Myelin sheath -- Diseases -- Periodicals; Inflammation -- Periodicals; Multiple sclerosis -- Periodicals; Central Nervous System Diseases -- Periodicals; Demyelinating Diseases -- Periodicals; Inflammation -- Periodicals; Multiple Sclerosis -- Periodicals; Système nerveux central -- Maladies -- Périodiques; Gaine de myéline -- Maladies -- Périodiques; Inflammation (Pathologie) -- Périodiques; Sclérose en plaques -- Périodiques; Electronic journals; 616.834005
• DOI: 10.1177/1352458519843051
• Languages: English
• ISSNs: 1352-4585

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.