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

Purpose

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.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: Fampridine-SR	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Fampyra Outcome Measures Study: a Study of Different Outcome Measures on the Effect of Fampyra

Resource links provided by NLM:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Dalfampridine

U.S. FDA Resources

Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:

The mean change in SSST [ Time Frame: SSST is measured before and at the end of four weeks of treatment ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Mean change in T25FW [ Time Frame: Four weeks ] [ Designated as safety issue: No ]
T25FW is measured before four weeks of treatment with Fampridine-SR and then on day 26, 27 or 28.
Mean change in hip flexion, knee flexion and knee extension force [ Time Frame: Four weeks ] [ Designated as safety issue: No ]
Force in the abovementioned areas is measured by dynamometry before four weeks of treatment with Fampridine-SR and on day 26, 27 or 28.
Mean change on Chair Rise Test [ Time Frame: Four weeks ] [ Designated as safety issue: No ]
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.
Mean change on 9-Hole Peg Test (9HPT) [ Time Frame: Four weeks ] [ Designated as safety issue: No ]
9HPT is measured before four weeks of treatment with Fampridine-SR and on day 26, 27 or 28.
Mean change on Symbol Digit Modalitites Test (SDMT) [ Time Frame: Four weeks ] [ Designated as safety issue: No ]
SDMT is measured before four weeks of treatment with Fampridine-SR and on day 26, 27 or 28.

Estimated Enrollment:	125
Study Start Date:	June 2012
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Fampridine-SR Initially all participants receive Fampridine-SR 10 mg BID in an open label enrichment phase lasting four weeks. Those 40% responding the most by SSST will go onto phase two. 50% of these will receive 10 mg Fampridine-SR BID for four weeks.	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. Other Name: Fampyra (Ampyra in the US).
Placebo Comparator: Placebo In the intervention phase 50% will receive placebo BID	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. Other Name: Fampyra (Ampyra in the US).

Arms

Assigned Interventions

Experimental: Fampridine-SR

Initially all participants receive Fampridine-SR 10 mg BID in an open label enrichment phase lasting four weeks. Those 40% responding the most by SSST will go onto phase two. 50% of these will receive 10 mg Fampridine-SR BID for four weeks.

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.

Other Name: Fampyra (Ampyra in the US).

Placebo Comparator: Placebo

In the intervention phase 50% will receive placebo BID

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.

Other Name: Fampyra (Ampyra in the US).

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01656148

Locations

Denmark
Esbjerg Hospital
Esbjerg, Denmark, 6700
Odense University Hospital
Odense, Denmark, 5000
Sønderborg Hospital
Sønderborg, Denmark, 6400
Vejle Hospital
Vejle, Denmark, 7100

Sponsors and Collaborators

University of Southern Denmark

Region Southern Denmark

Biogen Idec

Investigators

Principal Investigator:

Henrik B Jensen, MD

Institute for Regional Health Services Research, University of Southern Denmark

More Information

Publications:

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.

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.

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.

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.

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.

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. Epub 2008 Jul 30.

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.

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.

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.

Responsible Party:	Henrik Boye Jensen, MD, PhD Fellow, University of Southern Denmark
ClinicalTrials.gov Identifier:	NCT01656148 History of Changes
Other Study ID Numbers:	FAME, 2011-006151-10
Study First Received:	July 31, 2012
Last Updated:	November 2, 2012
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by University of Southern Denmark:

Multiple sclerosis
Walking disablility
Mobility
Six Spot Step Test

Outcome measures
Fampridine-SR
Fampyra

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

Pathologic Processes
4-Aminopyridine
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013