FAMPISEP
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Dalfampridine
Voltage-gated potassium channel blocker
What it measured
Main measures
6 Minute Walk Test (6MWT)
Timed 21 days
Walking and mobility
Other measures (46)
Verbal fluencies
Day 1
Bladder, bowel and sexual functionVerbal fluencies
7 days
Bladder, bowel and sexual functionVerbal fluencies
21 days
Bladder, bowel and sexual functionVerbal fluencies
28 days
Bladder, bowel and sexual functionVerbal fluencies
up to one year
Bladder, bowel and sexual functionSymbol Digit Modalities Test
Day 1
Thinking and memorySymbol Digit Modalities Test
7 days
Thinking and memorySymbol Digit Modalities Test
21 days
Thinking and memorySymbol Digit Modalities Test
28 days
Thinking and memorySymbol Digit Modalities Test
up to one year
Thinking and memory
Who could take part
MS (type not specified) · 18 to 80
Inclusion Criteria: * MS diagnostic regarding the modified McDonald criteria * EDSS status between 4.0 and 6.5 * patients able to walk during 6 minutes Exclusion Criteria: * increasing MS symptoms during the previous 60 days * history of epilepsy or epileptic seizure * immunotherapy change in the previous 60 days * beginning anti-spastic treatment in the previous 30 days * beginning treatment that is able to decrease fatigue symptoms in the previous 30 days * modification of the rehabilitation program during the study * renal insufficiency (creatinine clearance \<80ml.min-1 given by the Cockroft-Gault formula) * concomitant treatment by organic cation transporter 2 inhibitor * hypersensitivity to fampridine
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This prospective monocentric open label trial was realized in the Laboratory of Clinical Functional Exploration of Movement at the University Hospital of Besancon. Cognitive evaluations: 7 days before fampridine treatment initiation (Pre 1), on the day of fampridine treatment initiation (Pre 2), 14 and 21 days after fampridine treatment initiation, respectively Post 1 and Post 2. Gait evaluations were assessed at Pre 1, Pre 2 and Post 1. Fampridine was prescribed according to guidelines issued by the French Health Products Safety Agency at the dose of 10 mg twice daily. Fampridine is indicated for the improvement of walking in MS patients with a walking disability (EDSS 4-6.5). A walking test is recommended to evaluate improvement after 2 weeks of treatment. According to the practitioner evaluation between Pre 2 and Post 1 (i.e. before and after fampridine treatment), patients were classified into 2 groups: responders whose clinical status was improved and non-responders whose clinical status was not improved.
Papers
Results
Allart E, Benoit A, Blanchard-Dauphin A, Tiffreau V, Thevenon A, Zephir H, Outteryck O, Lacour A, Vermersch P. Sustained-released fampridine in multiple sclerosis: effects on gait parameters, arm function, fatigue, and quality of life. J Neurol. 2015 Aug;262(8):1936-45. doi: 10.1007/s00415-015-7797-1. Epub 2015 Jun 5.Results
Almarwani M, Perera S, VanSwearingen JM, Sparto PJ, Brach JS. The test-retest reliability and minimal detectable change of spatial and temporal gait variability during usual over-ground walking for younger and older adults. Gait Posture. 2016 Feb;44:94-9. doi: 10.1016/j.gaitpost.2015.11.014. Epub 2015 Nov 30.Results
Baert I, Freeman J, Smedal T, Dalgas U, Romberg A, Kalron A, Conyers H, Elorriaga I, Gebara B, Gumse J, Heric A, Jensen E, Jones K, Knuts K, Maertens de Noordhout B, Martic A, Normann B, Eijnde BO, Rasova K, Santoyo Medina C, Truyens V, Wens I, Feys P. Responsiveness and clinically meaningful improvement, according to disability level, of five walking measures after rehabilitation in multiple scleResults
Baroin A, Chopard G, Siliman G, Michoudet C, Vivot A, Vidal C, Mokadym H, Lavier A, Berger E, Rumbach L, Rude N. Validation of a new quality of life scale related to multiple sclerosis and relapses. Qual Life Res. 2013 Oct;22(8):1943-54. doi: 10.1007/s11136-012-0334-0. Epub 2012 Dec 18.Results
Bland JM, Altman DG. Measurement error. BMJ. 1996 Jun 29;312(7047):1654. doi: 10.1136/bmj.312.7047.1654. No abstract available.Results
Brochet B, Deloire MS, Bonnet M, Salort-Campana E, Ouallet JC, Petry KG, Dousset V. Should SDMT substitute for PASAT in MSFC? A 5-year longitudinal study. Mult Scler. 2008 Nov;14(9):1242-9. doi: 10.1177/1352458508094398. Epub 2008 Jul 24.Results
Confavreux C, Vukusic S. The clinical epidemiology of multiple sclerosis. Neuroimaging Clin N Am. 2008 Nov;18(4):589-622, ix-x. doi: 10.1016/j.nic.2008.09.002.Results
Debouverie M, Pittion-Vouyovitch S, Louis S, Guillemin F. Validity of a French version of the fatigue impact scale in multiple sclerosis. Mult Scler. 2007 Sep;13(8):1026-32. doi: 10.1177/1352458507077942.Results
de Vet HC, Terwee CB, Knol DL, Bouter LM. When to use agreement versus reliability measures. J Clin Epidemiol. 2006 Oct;59(10):1033-9. doi: 10.1016/j.jclinepi.2005.10.015. Epub 2006 Aug 10.Results
Fisk JD, Ritvo PG, Ross L, Haase DA, Marrie TJ, Schlech WF. Measuring the functional impact of fatigue: initial validation of the fatigue impact scale. Clin Infect Dis. 1994 Jan;18 Suppl 1:S79-83. doi: 10.1093/clinids/18.supplement_1.s79.
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History
Started
Feb 2014
Main results due
Mar 2019
Finished
Mar 2019
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