FAME - Fampyra Outcome Measures Study: a Study of Different Outcome Measures on the Effect of Fampyra

Multiple Sclerosis Clinical Trial

— FAME  

Official title:

Fampyra Outcome Measures Study: a Study of Different Outcome Measures on the Effect of Fampyra

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01656148
• Other study ID #: FAME
• Secondary ID: 2011-006151-10
• Status: Completed
• Phase: Phase 4
• Start date: June 2012
• Est. completion date: May 2014

Study information

• Verified date: August 2018
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Fampridine-SR
Subjects will all receive Fampridine-SR in an open label enrichment phase lasting four weeks. Those 40% improvin the most measured by SSST will go onto the intervention. Here randomization in a 1:1 key between Fampridine-SR and placebo will be undertaken. Treatment will be of either Fampridine-SR 10 mg BID or placebo BID for four weeks. Arms will be double blind.

Locations

Country	Name	City	State
Denmark	Esbjerg Hospital	Esbjerg
Denmark	Odense University Hospital	Odense
Denmark	Sønderborg Hospital	Sønderborg
Denmark	Vejle Hospital	Vejle

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern Denmark	Biogen, Region of Southern Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. Epub 2007 Jan 29. — View 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. Epub 2006 Feb 9. Review. — View Citation

Nieuwenhuis MM, Van Tongeren H, Sørensen 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean change in SSST	SSST is measured before treatment with Fampridine-SR. Then again measured at day 26, 27 or 28 of four weeks of treatment with Fampridine-SR.	SSST is measured before and at the end of four weeks of treatment
Secondary	Mean change in T25FW	T25FW is measured before four weeks of treatment with Fampridine-SR and then on day 26, 27 or 28.	Four weeks
Secondary	Mean change in hip flexion, knee flexion and knee extension force	Force in the abovementioned areas is measured by dynamometry before four weeks of treatment with Fampridine-SR and on day 26, 27 or 28.	Four weeks
Secondary	Mean change on Chair Rise Test	Time to rise from a chair five times is measured before four weeks of treatment with Fampridine-SR and on day 26, 27 or 28.	Four weeks
Secondary	Mean change on 9-Hole Peg Test (9HPT)	9HPT is measured before four weeks of treatment with Fampridine-SR and on day 26, 27 or 28.	Four weeks
Secondary	Mean change on Symbol Digit Modalitites Test (SDMT)	SDMT is measured before four weeks of treatment with Fampridine-SR and on day 26, 27 or 28.	Four weeks