Short and Long Term Multiple Outcomes in Persons With Multiple Sclerosis Treated by Fampridine.
NCT ID: NCT02849782
Last Updated: 2021-02-02
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
89 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-02-04
Study Completion Date
2019-03-01
Brief Summary
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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.
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.
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Detailed Description
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Multiple sclerosis (MS) is a chronic neurological disorder affecting young and middle-aged adults with a female to male ratio of more than 3:1. The cause of MS is unknown although it involves genetic susceptibility and environmental exposure. Since there is no known cure for MS, the main goals of treatment is to delay progression of the disease and to improve health-related quality of life (HRQoL) by masking patients' symptoms. Among several symptoms of MS (e.g., motor and cognitive impairments, optic neuritis, fatigue, pain, urinary dysfunction), gait impairment, defined as an activity limitation by the International Classification of Functioning Disability and Health, is one of the most common and disabling dysfunction in Persons with Multiple Sclerosis PwMS. Studies have reported that approximately 75 % of individuals with MS experience clinically significant walking disturbances. Likewise, fatigue, impairment of information-processing speed (IPS), attention, working memory and executive functions can occur in MS and can worsen during the evolution of the disease.
Studies have shown that MS symptomatic treatment by fampridine (4-aminopyridine) is associated with improvements in walking and muscle strength and possibly with cognition, vision, fatigue and spasticity. Indeed, fampridine is a potassium channel blocker which reduces the leakage of ionic current through these channels, prolonging repolarization and thus, enhancing action-potential formation in demyelinated axons. Presumably, by enhancing action-potential formation, more impulses might be conducted in the central nervous system (CNS) and neurological functions could be ameliorated. In recent phase III studies, Goodman et al. investigated the fampridine effect on the walk of individuals with MS during a timed 25-foot walk test (T25FW). Improvement in walking velocity (≈25 % from baseline) was found for 35-43 % of the individuals in the interventional group.
However, improvement in neuronal conduction induced by fampridine might not be limited to short distances of gait or even to motor functions and might also improve long distance ambulation or cognitive functions.
Different assessments have been used for measuring gait impairments in multiple sclerosis, including the Timed 25-Foot Walk (T25FW), Six-Minute Walk Test (6MWT), spatio-temporal gait parameters measured with an instrumented walkway or the Timed Up and Go test (TUG). These different assessments can be performed at different conditions: simple task, fast speed or dual task. In this last case, the gait is associated with a cognitive or another motor task. For cognitive assessments, Symbol Digit Modalities Test (SDMT) and verbal fluencies have been used in previous studies.
The aimed of the study was to evaluate the impact of fampridine in gait evaluating by long distance tests and to evaluate the impact of fampridine in fatigue and cognition.
Assessments of patients were performed 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. The first two assessments were intended to evaluate the variability of measurement without any treatment. A measurement of activity was performed by accelerometer during the period covering the first two assessments. The third assessment was intend to measure clinical improvements. The fourth seeks to show a potentially delayed action of fampridine on cognition.
Studies have shown that MS symptomatic treatment by fampridine (4-aminopyridine) is associated with improvements in walking and muscle strength and possibly with cognition, vision, fatigue and spasticity. Indeed, fampridine is a potassium channel blocker which reduces the leakage of ionic current through these channels, prolonging repolarization and thus, enhancing action-potential formation in demyelinated axons. Presumably, by enhancing action-potential formation, more impulses might be conducted in the central nervous system (CNS) and neurological functions could be ameliorated. In recent phase III studies, Goodman et al. investigated the fampridine effect on the walk of individuals with MS during a timed 25-foot walk test (T25FW). Improvement in walking velocity (≈25 % from baseline) was found for 35-43 % of the individuals in the interventional group.
However, improvement in neuronal conduction induced by fampridine might not be limited to short distances of gait or even to motor functions and might also improve long distance ambulation or cognitive functions.
Different assessments have been used for measuring gait impairments in multiple sclerosis, including the Timed 25-Foot Walk (T25FW), Six-Minute Walk Test (6MWT), spatio-temporal gait parameters measured with an instrumented walkway or the Timed Up and Go test (TUG). These different assessments can be performed at different conditions: simple task, fast speed or dual task. In this last case, the gait is associated with a cognitive or another motor task. For cognitive assessments, Symbol Digit Modalities Test (SDMT) and verbal fluencies have been used in previous studies.
The aimed of the study was to evaluate the impact of fampridine in gait evaluating by long distance tests and to evaluate the impact of fampridine in fatigue and cognition.
Assessments of patients were performed 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. The first two assessments were intended to evaluate the variability of measurement without any treatment. A measurement of activity was performed by accelerometer during the period covering the first two assessments. The third assessment was intend to measure clinical improvements. The fourth seeks to show a potentially delayed action of fampridine on cognition.
Conditions
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Multiple Sclerosis
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Fampridine responder
Persons who have been diagnosed as Multiple Sclerosis according to Mc Donald Criteria : person with Multiple Sclerosis (PwMS).
Fampridine was prescribed according to the guidelines issued by the French National Security Agency of Medicines and Health Products (ANSM) at the dose of 10 mg twice a day. According to official ANSM guidelines, the prescription is initially limited to 2 weeks of therapy, at which point a new assessment is performed by the medical practitioner to evaluate the clinical benefits. Fampridine responder is a PwMS with an improvement in the judgment of the practitioner.
Group Type
EXPERIMENTAL
Fampridine
Intervention Type
DRUG
Oral intake of 10 mg twice daily
Fampridine non responder
Persons who have been diagnosed as Multiple Sclerosis according to Mc Donald Criteria : person with Multiple Sclerosis (PwMS).
Fampridine was prescribed according to the guidelines issued by the French National Security Agency of Medicines and Health Products (ANSM) at the dose of 10 mg twice a day. According to official ANSM guidelines, the prescription is initially limited to 2 weeks of therapy, at which point a new assessment is performed by the medical practitioner to evaluate the clinical benefits. Fampridine non responder is a PwMS without any improvement in the judgment of the practitioner.
Group Type
ACTIVE_COMPARATOR
Fampridine
Intervention Type
DRUG
Oral intake of 10 mg twice daily
Interventions
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Fampridine
Oral intake of 10 mg twice daily
Intervention Type
DRUG
Other Intervention Names
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Fampyra
code CIS : 62483787
Eligibility Criteria
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Inclusion Criteria
* MS diagnostic regarding the modified McDonald criteria
* EDSS status between 4.0 and 6.5
* patients able to walk during 6 minutes
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Centre Hospitalier Universitaire de Besancon
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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CHU Jean Minjoz
Besançon, , France
Site Status
Countries
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France
References
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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.
Reference Type
RESULT
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.
Reference Type
RESULT
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 sclerosis: a European multicenter study. Neurorehabil Neural Repair. 2014 Sep;28(7):621-31. doi: 10.1177/1545968314521010. Epub 2014 Feb 6.
Reference Type
RESULT
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.
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RESULT
Bland JM, Altman DG. Measurement error. BMJ. 1996 Jun 29;312(7047):1654. doi: 10.1136/bmj.312.7047.1654. No abstract available.
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RESULT
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.
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RESULT
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.
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RESULT
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.
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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.
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RESULT
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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RESULT
Givon U, Zeilig G, Achiron A. Gait analysis in multiple sclerosis: characterization of temporal-spatial parameters using GAITRite functional ambulation system. Gait Posture. 2009 Jan;29(1):138-42. doi: 10.1016/j.gaitpost.2008.07.011. Epub 2008 Oct 31.
Reference Type
RESULT
Goldman MD, Marrie RA, Cohen JA. Evaluation of the six-minute walk in multiple sclerosis subjects and healthy controls. Mult Scler. 2008 Apr;14(3):383-90. doi: 10.1177/1352458507082607. Epub 2007 Oct 17.
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RESULT
Goodkin DE. EDSS reliability. Neurology. 1991 Feb;41(2 ( Pt 1)):332. doi: 10.1212/wnl.41.2_part_1.332. No abstract available.
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RESULT
Goodman AD, Bethoux F, Brown TR, Schapiro RT, Cohen R, Marinucci LN, Henney HR 3rd, Blight AR; MS-F203, MS-F204, and Extension Study Investigators. Long-term safety and efficacy of dalfampridine for walking impairment in patients with multiple sclerosis: Results of open-label extensions of two Phase 3 clinical trials. Mult Scler. 2015 Sep;21(10):1322-31. doi: 10.1177/1352458514563591. Epub 2015 Jan 12.
Reference Type
RESULT
Goodman AD, Brown TR, Edwards KR, Krupp LB, Schapiro RT, Cohen R, Marinucci LN, Blight AR; MSF204 Investigators. A phase 3 trial of extended release oral dalfampridine in multiple sclerosis. Ann Neurol. 2010 Oct;68(4):494-502. doi: 10.1002/ana.22240.
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RESULT
Hobart JC, Riazi A, Lamping DL, Fitzpatrick R, Thompson AJ. Measuring the impact of MS on walking ability: the 12-Item MS Walking Scale (MSWS-12). Neurology. 2003 Jan 14;60(1):31-6. doi: 10.1212/wnl.60.1.31.
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RESULT
Hobart J, Blight AR, Goodman A, Lynn F, Putzki N. Timed 25-foot walk: direct evidence that improving 20% or greater is clinically meaningful in MS. Neurology. 2013 Apr 16;80(16):1509-17. doi: 10.1212/WNL.0b013e31828cf7f3. Epub 2013 Mar 27.
Reference Type
RESULT
Kalron A, Dvir Z, Achiron A. Walking while talking--difficulties incurred during the initial stages of multiple sclerosis disease process. Gait Posture. 2010 Jul;32(3):332-5. doi: 10.1016/j.gaitpost.2010.06.002. Epub 2010 Jul 1.
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RESULT
Kalron A. Gait variability across the disability spectrum in people with multiple sclerosis. J Neurol Sci. 2016 Feb 15;361:1-6. doi: 10.1016/j.jns.2015.12.012. Epub 2015 Dec 10.
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Learmonth YC, Dlugonski D, Pilutti LA, Sandroff BM, Klaren R, Motl RW. Psychometric properties of the Fatigue Severity Scale and the Modified Fatigue Impact Scale. J Neurol Sci. 2013 Aug 15;331(1-2):102-7. doi: 10.1016/j.jns.2013.05.023. Epub 2013 Jun 20.
Reference Type
RESULT
Learmonth YC, Paul L, McFadyen AK, Mattison P, Miller L. Reliability and clinical significance of mobility and balance assessments in multiple sclerosis. Int J Rehabil Res. 2012 Mar;35(1):69-74. doi: 10.1097/MRR.0b013e328350b65f.
Reference Type
RESULT
Moon Y, Wajda DA, Motl RW, Sosnoff JJ. Stride-Time Variability and Fall Risk in Persons with Multiple Sclerosis. Mult Scler Int. 2015;2015:964790. doi: 10.1155/2015/964790. Epub 2015 Dec 30.
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RESULT
Motl RW, Dlugonski D, Suh Y, Weikert M, Fernhall B, Goldman M. Accelerometry and its association with objective markers of walking limitations in ambulatory adults with multiple sclerosis. Arch Phys Med Rehabil. 2010 Dec;91(12):1942-7. doi: 10.1016/j.apmr.2010.08.011.
Reference Type
RESULT
Motl RW, Sosnoff JJ, Dlugonski D, Pilutti LA, Klaren R, Sandroff BM. Walking and cognition, but not symptoms, correlate with dual task cost of walking in multiple sclerosis. Gait Posture. 2014 Mar;39(3):870-4. doi: 10.1016/j.gaitpost.2013.11.023. Epub 2013 Dec 14.
Reference Type
RESULT
Pilutti LA, Dlugonski D, Sandroff BM, Suh Y, Pula JH, Sosnoff JJ, Motl RW. Gait and six-minute walk performance in persons with multiple sclerosis. J Neurol Sci. 2013 Nov 15;334(1-2):72-6. doi: 10.1016/j.jns.2013.07.2511. Epub 2013 Jul 30.
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RESULT
Polman CH, Reingold SC, Edan G, Filippi M, Hartung HP, Kappos L, Lublin FD, Metz LM, McFarland HF, O'Connor PW, Sandberg-Wollheim M, Thompson AJ, Weinshenker BG, Wolinsky JS. Diagnostic criteria for multiple sclerosis: 2005 revisions to the "McDonald Criteria". Ann Neurol. 2005 Dec;58(6):840-6. doi: 10.1002/ana.20703.
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RESULT
Sandroff BM, Pilutti LA, Motl RW. Does the six-minute walk test measure walking performance or physical fitness in persons with multiple sclerosis? NeuroRehabilitation. 2015;37(1):149-55. doi: 10.3233/NRE-151247.
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RESULT
van Uden CJ, Besser MP. Test-retest reliability of temporal and spatial gait characteristics measured with an instrumented walkway system (GAITRite). BMC Musculoskelet Disord. 2004 May 17;5:13. doi: 10.1186/1471-2474-5-13.
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RESULT
Vlaar AM, Wade DT. Verbal fluency assessment of patients with multiple sclerosis: test-retest and inter-observer reliability. Clin Rehabil. 2003 Nov;17(7):756-64. doi: 10.1191/0269215503cr674oa.
Reference Type
RESULT
Wajda DA, Motl RW, Sosnoff JJ. Dual task cost of walking is related to fall risk in persons with multiple sclerosis. J Neurol Sci. 2013 Dec 15;335(1-2):160-3. doi: 10.1016/j.jns.2013.09.021. Epub 2013 Sep 20.
Reference Type
RESULT
Magnin E, Sagawa Y, Moulin T, Decavel P. What Are the Minimal Detectable Changes in SDMT and Verbal Fluency Tests for Assessing Changes in Cognitive Performance in Persons with Multiple Sclerosis and Non-Multiple Sclerosis Controls? Eur Neurol. 2020;83(3):263-270. doi: 10.1159/000508607. Epub 2020 Jul 7.
Reference Type
DERIVED
Other Identifiers
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API/2014/49
Identifier Type: -
Identifier Source: org_study_id
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