Clinical trial NCT01656148: FAME - Fampyra Outcome Measures Study: a Study of Different Outcome Measures on the Effect of Fampyra
Official title: Fampyra Outcome Measures Study: a Study of Different Outcome Measures on the Effect of Fampyra
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Walking disablility
Mobility
Six Spot Step Test
Outcome measures
Fampridine-SR
Fampyra
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Region of Southern Denmark
name: Biogen
First posted: 2012-08-02
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: The mean change in SSST
timeFrame: SSST is measured before and at the end of four weeks of treatment
Secondary outcomes:
measure: Mean change in T25FW
timeFrame: Four weeks
measure: Mean change in hip flexion, knee flexion and knee extension force
timeFrame: Four weeks
measure: Mean change on Chair Rise Test
timeFrame: Four weeks
measure: Mean change on 9-Hole Peg Test (9HPT)
timeFrame: Four weeks
measure: Mean change on Symbol Digit Modalitites Test (SDMT)
timeFrame: Four weeks
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Esbjerg Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Sønderborg
country: Denmark
facility: Sønderborg Hospital
city: Vejle
country: Denmark
facility: Vejle Hospital
Study officials:
affiliation: Institute for Regional Health Services Research, University of Southern Denmark
name: Henrik B Jensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Nieuwenhuis MM, Van Tongeren H, Sorensen PS, Ravnborg M. The six spot step test: a new measurement for walking ability in multiple sclerosis. Mult Scler. 2006 Aug;12(4):495-500. doi: 10.1191/1352458506ms1293oa.
citation: Jensen HB, Nielsen JL, Ravnborg M, Dalgas U, Aagaard P, Stenager E. 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 Nov;10:137-144. doi: 10.1016/j.msard.2016.07.019. Epub 2016 Sep 14.
citation: 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.