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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-006151-10 | EudraCT Number |
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| Name | Class |
|---|---|
| Region of Southern Denmark | OTHER |
| Biogen | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Placebo | Placebo Comparator | In the intervention phase 50% will receive placebo BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fampridine-SR | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Mean change in hip flexion, knee flexion and knee extension force |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henrik B Jensen, MD | Institute for Regional Health Services Research, University of Southern Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Esbjerg Hospital | Esbjerg | 6700 | Denmark | |||
| Odense University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12804404 | 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. | |
| 16472864 | 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. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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Not provided
| ID | Term |
|---|---|
| D015761 | 4-Aminopyridine |
| ID | Term |
|---|---|
| D000631 | Aminopyridines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
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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 |
| 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 |
| 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 |
| 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 |
| Odense |
| 5000 |
| Denmark |
| Sønderborg Hospital | Sønderborg | 6400 | Denmark |
| Vejle Hospital | Vejle | 7100 | Denmark |
| 9109861 | 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. |
| 17439905 | 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. |
| 19249634 | 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. |
| 18672472 | 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. |
| 20976768 | 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. |
| 10355672 | 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. |
| 16900764 | Background | 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. |
| 27919481 | Derived | 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. |
| 24852920 | Derived | 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. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |