MUST
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
Gait Profile Score (GPS) - (subgroup of 30 allocated to 3D gait analysis)
Baseline, 14 days (Change from baseline to 14 days follow-up)
Walking and mobility
Other measures (10)
Gait Variable Scores (GVS) - (subgroup of 30 allocated to 3D gait analysis)
Baseline, 14 days (Change from baseline to 14 days follow-up)
Walking and mobilityFunctional test - 6 Spot Step Test (SSST)
Baseline, 14 days (Change from baseline to 14 days follow-up)
Walking and mobilityFunctional test - Timed 25 Footwalk (T25-FW)
Baseline, 14 days (Change from baseline to 14 days follow-up)
Disability progressionWalking and mobilityFunctional test - 2-minute Walk Test (2MWT)
Baseline, 14 days (Change from baseline to 14 days follow-up)
Walking and mobilityWalking speed - (subgroup of 30 allocated to 3D gait analysis)
Baseline, 14 days (Change from baseline to 14 days follow-up)
Walking and mobilityStep length - (subgroup of 30 allocated to 3D gait analysis)
Baseline, 14 days (Change from baseline to 14 days follow-up)
Walking and mobilityStep width - (subgroup of 30 allocated to 3D gait analysis)
Baseline, 14 days (Change from baseline to 14 days follow-up)
Walking and mobilityStride length - (subgroup of 30 allocated to 3D gait analysis)
Baseline, 14 days (Change from baseline to 14 days follow-up)
Walking and mobilityCadence - (subgroup of 30 allocated to 3D gait analysis)
Baseline, 14 days (Change from baseline to 14 days follow-up)
Walking and mobilityQuestionnaire - 12-Item Multiple Sclerosis Walking Scale (MSWS-12), Danish version
Baseline, 14 days (Change from baseline to 14 days follow-up)
Walking and mobility
Who could take part
MS (type not specified) · 18 to 100
Inclusion Criteria: * Fills the criteria for fampridine treatment * Fills the diagnostic McDonald criteria for MS * Age between 18 and 100 years * EDSS between 4 and 7 Exclusion Criteria: * Diagnosed epilepsy * MS attack or an acute decrease of functional capacity within the last 60 days * Change in immunomodulatory treatment within the last 60 days * Cancer within the last 5 years * Clinically significant systemic disease * Concurrent treatment with cimetidine, carvediol, propanolol and metformine
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The primary study, as outlined in the original trial registration, aiming to use ultrasound speckle tracking (STU) to monitor muscle contractility in multiple sclerosis (MS) patients receiving vs. not receiving fampridine, as well as to relate these results to performance-based measures and biomarkers to explore disease progression and muscle activity, has been cancelled. Instead four exploratory studies that originate from the initial trial registration but with revised aims, outcome measures and time points, have been prepared - see the DEVIATIONS TO TRIAL PROTOCOL included in the Statistical Analysis Plan filed under "Document section". Summary of original trial registration: Despite effective treatments, the majority of patients with multiple sclerosis experience walking impairments to a degree where walking aids or a wheelchair is required. Since 2009, medical treatment of walking impairments has been possible with fampridine, which has proven effective in approximately 40% of the patients. At present, the treatment is offered on the basis of a measurable improved walking function evaluated by simple performance-based walking tests. The treatment is offered on the basis of a measurable improved walking distance. This is shown today using simple performance-based walking tests that are difficult to complete for those MS patients who are without gait function but could still benefit from fampridine treatment. Ultrasound speckle tracking is a non-invasive ultrasound technique, with the potential to measure muscle function, including muscle contractility (through strain). Ultrasound speckle tracking is designed for dynamic cardiac muscular examination, but can in a modified version be used for assessment of the skeletal muscles. The purpose of this project is to use ultrasound speckle tracking to monitor muscle contractility in MS patients receiving vs. not receiving fampridine treatment. Furthermore, to relate these results to biomarkers in blood and urine to examine disease progression and muscle activity.
Papers
Results
Thorning M, Nielsen HH, Frich LH, Jensen HB, Lambertsen KL, Holsgaard-Larsen A. Gait quality and function after fampridine treatment in patients with multiple sclerosis - A prospective cohort study. Clin Biomech (Bristol). 2022 Dec;100:105826. doi: 10.1016/j.clinbiomech.2022.105826. Epub 2022 Nov 17.Background
Gottberg K, Einarsson U, Ytterberg C, de Pedro Cuesta J, Fredrikson S, von Koch L, Widen Holmqvist L. Health-related quality of life in a population-based sample of people with multiple sclerosis in Stockholm County. Mult Scler. 2006 Oct;12(5):605-12. doi: 10.1177/1352458505070660.Background
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.Background
Goodman AD, Brown TR, Krupp LB, Schapiro RT, Schwid SR, Cohen R, Marinucci LN, Blight AR; Fampridine MS-F203 Investigators. Sustained-release oral fampridine in multiple sclerosis: a randomised, double-blind, controlled trial. Lancet. 2009 Feb 28;373(9665):732-8. doi: 10.1016/S0140-6736(09)60442-6.Background
Solari A, Uitdehaag B, Giuliani G, Pucci E, Taus C. Aminopyridines for symptomatic treatment in multiple sclerosis. Cochrane Database Syst Rev. 2001;2002(4):CD001330. doi: 10.1002/14651858.CD001330.Background
Jensen H, Ravnborg M, Mamoei S, Dalgas U, Stenager E. Changes in cognition, arm function and lower body function after slow-release Fampridine treatment. Mult Scler. 2014 Dec;20(14):1872-80. doi: 10.1177/1352458514533844. Epub 2014 May 22.Background
Jensen HB, Mamoei S, Ravnborg M, Dalgas U, Stenager E. Distribution-based estimates of minimum clinically important difference in cognition, arm function and lower body function after slow release-fampridine treatment of patients with multiple sclerosis. Mult Scler Relat Disord. 2016 May;7:58-60. doi: 10.1016/j.msard.2016.03.007. Epub 2016 Mar 18.Background
Jensen HB, Ravnborg M, Dalgas U, Stenager E. 4-Aminopyridine for symptomatic treatment of multiple sclerosis: a systematic review. Ther Adv Neurol Disord. 2014 Mar;7(2):97-113. doi: 10.1177/1756285613512712.Background
Mondillo S, Galderisi M, Mele D, Cameli M, Lomoriello VS, Zaca V, Ballo P, D'Andrea A, Muraru D, Losi M, Agricola E, D'Errico A, Buralli S, Sciomer S, Nistri S, Badano L; Echocardiography Study Group Of The Italian Society Of Cardiology (Rome, Italy). Speckle-tracking echocardiography: a new technique for assessing myocardial function. J Ultrasound Med. 2011 Jan;30(1):71-83. doi: 10.7863/jum.2011.
Loading reviews and guidelines…
Related trials
- AmpPT
Phase 3 · Recruiting
Still running
- RESTORE
Phase 3 · Stopped early
Stopped: not working
- New strategies in neurological diseases
Phase 4 · Ongoing
Still running
- FAMILY
Completed
Result in a paper, not read yet
- Fampridine Study in Activities of Daily Living
Phase 4 · Completed
No result found
- Fampridine Pregnancy Exposure Registry
Stopped early
Stopped early
History
Started
Dec 2018
Main results due
Oct 2021
Finished
Oct 2021
Assembled by software from public sources and not checked by people. Each record links to its source. Report an error