Evidence map›Paper›PMID 24460863›Full record

Trial reportTrials2014

Fluoxetine in progressive multiple sclerosis (FLUOX-PMS): study protocol for a randomized controlled trial.

Melissa Cambron, Jop Mostert, Patrick Haentjens, Marie D'Hooghe, Guy Nagels, Barbara Willekens, Dorothea Heersema, Jan Debruyne, Wim Van Hecke, Luc Algoed and 12 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.3field-weighted citation impact, top 22% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 21 citations in OpenAlex.

  1. Evolution of clinical trials in multiple sclerosis.Therapeutic advances in neurological disorders · 2019
    Review
  2. Review
  3. Review
  4. Review
  5. Imaging outcome measures for progressive multiple sclerosis trials.Multiple sclerosis (Houndmills, Basingstoke, England) · 2017
    Review
  6. Review
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors at 15 institutions in 2 countries.

Melissa CambronDepartment of Neurology, University Hospital Brussel, Center for Neurosciences Vrije Universiteit Brussel (VUB) UZ Brussel, Laarbeeklaan 101, 1090 Brussels, Belgium. melissa.cambron@gmail.com.
Jop Mostert
Patrick Haentjens
Marie D'Hooghe
Guy Nagels
Barbara Willekens
Dorothea Heersema
Jan Debruyne
Wim Van Hecke
Luc Algoed
Nina De Klippel
Erwin Fosselle
Guy Laureys
Henri Merckx
Bart Van Wijmeersch
Ludo Vanopdenbosch
Wim Verhagen
Raymond Hupperts
Gerald Hengstman
Veronique Michiels
Annick Van Merhaegen-Wieleman
Jacques De Keyser
Vrije Universiteit Brussel · BENational MS Center MelsbroekUniversity Medical Center Groningen · NLAntwerp University Hospital · BEAZ Maria Middelares · BEAZ Sint-Jan · BECanisius-Wilhelmina Ziekenhuis · NLGhent University Hospital · BEIcometrix (Belgium) · BEJessa Hospital · BEMariaziekenhuis · BEOnze Lieve Vrouwziekenhuis Hospital · BERadboud University Nijmegen · NLRijnstate Hospital · NLZuyderland Medisch Centrum · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCurrently 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/

designThe 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 registrationEudra-CT: 2011-003775-11.

Indexed as

Research DesignAdultAgedBelgiumBrainClinical ProtocolsCognitionDisability EvaluationDisease ProgressionDouble-Blind MethodFemaleFluoxetineHumansMagnetic Resonance ImagingMaleMiddle AgedFluoxetineNeuroprotective Agents

Identifiers

PMID24460863
PMCPMC3931920
OpenAlexW1965743133

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.