FAME - Fampyra Outcome Measures Study: a Study of Different Outcome Me
Fampyra Outcome Measures Study: a Study of Different Outcome Measures on the Effect of Fampyra
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
The mean change in SSST
SSST is measured before and at the end of four weeks of treatment
The mean change in six spot step test from day 0 to 28.
Other measures (6)
Mean change in T25FW
Four weeks
Disability progressionMean change in hip flexion, knee flexion and knee extension force
Four weeks
Mean change on Chair Rise Test
Four weeks
Mean change on 9-Hole Peg Test (9HPT)
Four weeks
Disability progressionMean change on Symbol Digit Modalitites Test (SDMT)
Four weeks
Thinking and memoryMean changes in Timed 25 Foot Walk, Hip Flexion Dynamometry, Knee Extension Dynamometry, Chair Rise Test, 9 Hole Peg Test and Symbol Digit Modalities Test.
Disability progressionThinking and memoryWalking and mobility
Who could take part
MS (type not specified) · 18 to 60 · EDSS 4 to 7
Show the full criteria
Inclusion criteria
* Patients with clinically definite multiple sclerosis diagnosed according to the McDonald criteria * EDSS 4-7 * Pyramidal FS >= 2
Exclusion criteria
* History of epileptic seizures * MS relapse or change in disease modifying treatment (DMT) within 60 days * cancer within five years * uncontrolled hypertension * clinically important cardiac, hepatic, renal or pulmonary disease * pregnancy * breast feeding * concomitant treatment with cimetidine, carvedilol, propranolol and metformin
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Fampridine-SR is registered for the treatment of walking incapacity in MS patients. Two pivotal trials show that app. 40% of MS patients with walking incapacity can improve walking speed averagely 25% when recieving the drug. This has been shown using the Timed 25 Foot Walk Test (T25FW). No effect on cognition and upper limb function has been shown, but this has not been investigated in patients responding to the drug measured by the abovementioned test. The question is if this will be the case and also if another walking test, termed the Six Spot Step Test (SSST), will be more sensitive to the effect of Fampridine-SR. Primary outcome measure is the effect measured by SSST. The hypothesis is that SSST is not less sensitive to the effect of Fampridine-SR than T25FW.
Papers
Results
Effect of slow release-Fampridine on muscle strength, rate of force development, functional capacity and cognitive function in an enriched population of MS patients. A randomized, double blind, placebo controlled study.Mult Scler Relat Disord · 2016
Results
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
Solari A, Uitdehaag B, Giuliani G, Pucci E, Taus C. Aminopyridines for symptomatic treatment in multiple sclerosis. Cochrane Database Syst Rev. 2002;(4):CD001330. doi: 10.1002/14651858.CD001330.Background
Judge SI, Bever CT Jr. Potassium channel blockers in multiple sclerosis: neuronal Kv channels and effects of symptomatic treatment. Pharmacol Ther. 2006 Jul;111(1):224-59. doi: 10.1016/j.pharmthera.2005.10.006. Epub 2006 Feb 9.Background
Schwid SR, Petrie MD, McDermott MP, Tierney DS, Mason DH, Goodman AD. Quantitative assessment of sustained-release 4-aminopyridine for symptomatic treatment of multiple sclerosis. Neurology. 1997 Apr;48(4):817-21. doi: 10.1212/wnl.48.4.817.Background
Goodman AD, Cohen JA, Cross A, Vollmer T, Rizzo M, Cohen R, Marinucci L, Blight AR. Fampridine-SR in multiple sclerosis: a randomized, double-blind, placebo-controlled, dose-ranging study. Mult Scler. 2007 Apr;13(3):357-68. doi: 10.1177/1352458506069538. Epub 2007 Jan 29.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
Goodman AD, Brown TR, Cohen JA, Krupp LB, Schapiro R, Schwid SR, Cohen R, Marinucci LN, Blight AR; Fampridine MS-F202 Study Group. Dose comparison trial of sustained-release fampridine in multiple sclerosis. Neurology. 2008 Oct 7;71(15):1134-41. doi: 10.1212/01.wnl.0000326213.89576.0e. Epub 2008 Jul 30.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
Cutter GR, Baier ML, Rudick RA, Cookfair DL, Fischer JS, Petkau J, Syndulko K, Weinshenker BG, Antel JP, Confavreux C, Ellison GW, Lublin F, Miller AE, Rao SM, Reingold S, Thompson A, Willoughby E. Development of a multiple sclerosis functional composite as a clinical trial outcome measure. Brain. 1999 May;122 ( Pt 5):871-82. doi: 10.1093/brain/122.5.871.
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History
Started
Jun 2012
Main results due
May 2014
Finished
May 2014