NCT01656148

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for phase_4 multiple-sclerosis

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

August 23, 2018

Status Verified

August 1, 2018

Enrollment Period

1.9 years

First QC Date

July 31, 2012

Last Update Submit

August 22, 2018

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosisWalking disablilityMobilitySix Spot Step TestOutcome measuresFampridine-SRFampyra

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Mean change in T25FW

    Four weeks

  • Mean 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

  • Mean change on Symbol Digit Modalitites Test (SDMT)

    Four weeks

Study Arms (2)

Fampridine-SR

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

In the intervention phase 50% will receive placebo BID

Drug: Fampridine-SR

Interventions

Fampridine-SRDRUG

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.

Also known as: Fampyra (Ampyra in the US).
Fampridine-SRPlacebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with clinically definite multiple sclerosis diagnosed according to the McDonald criteria
  • EDSS 4-7
  • Pyramidal FS \>= 2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Esbjerg Hospital

Esbjerg, 6700, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Sønderborg Hospital

Sønderborg, 6400, Denmark

Location

Vejle Hospital

Vejle, 7100, Denmark

Location

Related Publications (11)

  • 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.

    PMID: 12804404BACKGROUND

  • 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.

    PMID: 16472864BACKGROUND

  • 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.

    PMID: 9109861BACKGROUND

  • 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.

    PMID: 17439905BACKGROUND

  • 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.

    PMID: 19249634BACKGROUND

  • 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.

    PMID: 18672472BACKGROUND

  • 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.

    PMID: 20976768BACKGROUND

  • 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.

    PMID: 10355672BACKGROUND

  • 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.

    PMID: 16900764BACKGROUND

  • 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.

    PMID: 27919481DERIVED

  • 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.

    PMID: 24852920DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

4-Aminopyridine

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

AminopyridinesAminesOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Henrik B Jensen, MD

    Institute for Regional Health Services Research, University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD Fellow

Study Record Dates

First Submitted

July 31, 2012

First Posted

August 2, 2012

Study Start

June 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

August 23, 2018

Record last verified: 2018-08

Locations

DK(4)