Evidence map›Paper›PMID 25921050›Full record

Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2016

Prolonged-release fampridine and walking and balance in MS: randomised controlled MOBILE trial.

Raymond Hupperts, Jan Lycke, Christine Short, Claudio Gasperini, Manjit McNeill, Rossella Medori, Agata Tofil-Kaluza, Maria Hovenden, Lahar R Mehta, Jacob Elkins

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Multiple sclerosis (Houndmills, Basingstoke, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01597297 (A Multicenter, Randomized, Double-Blind, Placebo-Controlled Exploratory Study to Assess the Effect of Treatment With Prolonged-Release Fampridine), which is not on this map. Cited by 27 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 4 pooled it
6.0field-weighted citation impact, top 3% 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.

NCT01597297 phase2completednot on this map

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Exploratory Study to Assess the Effect of Treatment With Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Walking Ability and Balance in Subjects With Multiple Sclerosis

TypeinterventionalSponsorBiogenRan2012 to 2013Enrolled132ConditionsMultiple SclerosisArmsBIIB041 (PR Fampridine), Placebo
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 4 syntheses or guidelines pooled it, 67 citations in OpenAlex.

  1. Pooled it
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  8. Article
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  12. Article
  13. Efficacy of prolonged-release fampridineTherapeutic advances in neurological disorders · 2022
    Article
  14. Observational
  15. Neuroprotective Properties of 4-Aminopyridine.Neurology(R) neuroimmunology & neuroinflammation · 2021
    Review
  16. Article
  17. Article
  18. Review
  19. Review
  20. Spotlight on postural control in patients with multiple sclerosis.Degenerative neurological and neuromuscular disease · 2018
    Review
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

10 authors at 7 institutions in 6 countries.

Raymond HuppertsOrbis Medical Center, Sittard-Geleen, the Netherlands r.hupperts@orbisconcern.nl.
Jan LyckeInstitute of Neuroscience and Physiology, The Sahlgrenska Academy, Gothenburg, Sweden.
Christine ShortQueen Elizabeth II Health Sciences Centre, Halifax, Canada.
Claudio GasperiniHospital San Camillo Forlanini, Rome, Italy.
Manjit McNeillBiogen, Maidenhead, UK.
Rossella MedoriBiogen, Cambridge, MA, USA.
Agata Tofil-KaluzaBiogen, Maidenhead, UK.
Maria HovendenExcel Scientific Solutions, Southport, CT, USA.
Lahar R MehtaBiogen, Cambridge, MA, USA.
Jacob ElkinsBiogen, Cambridge, MA, USA.
Biogen (United States) · USBiogen (United Kingdom) · GBCarlo Forlanini Hospital · ITQueen Elizabeth II Health Sciences Centre · CAScientific Solutions (United States) · USUniversity of Gothenburg · SEZuyderland Medisch Centrum · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMobility impairment is a common disability in MS and negatively impacts patients' lives.

objectiveEvaluate the effect of prolonged-release (PR) fampridine (extended-release dalfampridine in the United States) on self-assessed walking disability, dynamic/static balance and safety in patients with MS.

methodsMOBILE was a randomised, double-blind, exploratory, placebo-controlled trial. Patients with progressive/relapsing-remitting MS and Expanded Disability Status Scale score of 4.0-7.0 were treated with PR-fampridine or placebo twice daily for 24 weeks. Efficacy endpoints included change from baseline in the 12-item MS Walking Scale (MSWS-12), Timed Up and Go (TUG) test and Berg Balance Scale (BBS).

results132 patients were randomised at 24 sites in six countries. PR-fampridine therapy resulted in greater median improvements from baseline in MSWS-12 score, TUG speed and BBS total score versus placebo over 24 weeks. A higher proportion of patients receiving PR-fampridine versus placebo experienced significant improvements at MSWS-12 improvement thresholds ⩾7 (p = 0.0275), ⩾8 (p = 0.0153) and ⩾9 points (p = 0.0088) and TUG speed thresholds ⩾10% (p = 0.0021) and ⩾15% (p = 0.0262). PR-fampridine was well tolerated.

conclusionsPR-fampridine therapy resulted in early and sustained improvements in broad measures of walking and balance over six months.

Indexed as

Postural BalanceWalking4-AminopyridineDelayed-Action PreparationsDouble-Blind MethodFemaleHumansMaleMiddle AgedMobility LimitationMultiple SclerosisPotassium Channel Blockers4-AminopyridineDelayed-Action PreparationsPotassium Channel BlockersbalanceFampridinemultiple sclerosisrandomised clinical trialwalking

Identifiers

PMID25921050
PMCPMC4749757
OpenAlexW2015050903

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.