Open-Label Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) on Quality of Life as Reported by Participants With Multiple Sclerosis
NCT ID: NCT01480076
Last Updated: 2017-03-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
901 participants
INTERVENTIONAL
2012-02-29
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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(BIIB041) Fampridine
All participants take 10 mg fampridine twice daily for the first 4 weeks. If deemed a treatment responder, a participant continues 10 mg fampridine twice daily for 44 weeks. Treatment non-responders can continue without treatment by completing quality of life questionnaires.
Fampridine
Supplied as a 10 mg twice daily tablet and taken twice daily. Doses must be spaced at least 12 hours apart.
Interventions
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Fampridine
Supplied as a 10 mg twice daily tablet and taken twice daily. Doses must be spaced at least 12 hours apart.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have a diagnosis of primary-progressive, secondary-progressive, progressive-remitting, or relapsing-remitting multiple sclerosis (MS) per revised McDonald Committee criteria (\[Polman et al, 2011\]) as defined by Lublin and Reingold \[Lublin and Reingold 1996\] of at least 3 months duration.
* Have a walking impairment as determined by the Investigator.
* Able to perform the Timed 25-foot Walk Test with or without a walking aid.
* Female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
* Able to understand and comply with the requirements of the protocol.
Exclusion Criteria
* Any history of seizure, epilepsy, or other convulsive disorder, with the exception of febrile seizures in childhood.
* An estimated creatinine clearance of \<80 mL/minute.
* Subject needs to take medicinal products that are inhibitors of organic cation transporter 2 (OCT2 \[e.g., cimetidine\]).
* Female subjects who are currently pregnant or who are considering becoming pregnant while participating in the study.
* Female subjects who are currently breastfeeding.
* Previous exposure to fampridine.
18 Years
75 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Research Site
Concord, New South Wales, Australia
Research Site
Kogarah, New South Wales, Australia
Research Site
Liverpool, New South Wales, Australia
Research Site
New Lambton Heights, New South Wales, Australia
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Auchenflower, Queensland, Australia
Research Site
Box Hill, Victoria, Australia
Research Site
Clayton, Victoria, Australia
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Fitzroy, Victoria, Australia
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Heidelberg, Victoria, Australia
Research Site
Brasschaat, , Belgium
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Brussels, , Belgium
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Diepenbeek, , Belgium
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Fraiture-en-Condroz, , Belgium
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Ghent, , Belgium
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Liège, , Belgium
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Melsbroek, , Belgium
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Overpelt, , Belgium
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Sijsele-Damme, , Belgium
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Wilrijk, , Belgium
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Copenhagen, , Denmark
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Nice, Alpes-Maritimes, France
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Strasbourg, Bas-Rhin, France
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Caen, Calvados, France
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Bordeaux, Gironde 5, France
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Rennes, Ille-et-Vilaine, France
Research Site
Nantes, Loire-Atlantique 6, France
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Reims, Marne, France
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Clemont-Ferrand, Rhone, France
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Paris, Seine-Saint-Denis 14, France
Research Site
Amiens, Somme, France
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Paris, , France
Research Site
Heidenheim, Bad Wuerttemberg, Germany
Research Site
Kassel, Hesse, Germany
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Oldenburg, Lower Saxony, Germany
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Münster, North Rhine-Westphalia, Germany
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Berlin, , Germany
Research Site
Erbach im Odenwald, , Germany
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Hamburg, , Germany
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Jena, , Germany
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Osnabrück, , Germany
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Schwendi, , Germany
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Bari, , Italy
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Florence, , Italy
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Milan, , Italy
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Padua, , Italy
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Roma, , Italy
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Eindhoven, , Netherlands
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Hoorn, , Netherlands
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Nijmegen, , Netherlands
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Tilburg, , Netherlands
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Amadora, , Portugal
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Coimbra, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Salford, Greater Manchester, United Kingdom
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Nottingham, Northamptonshire, United Kingdom
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Glasgow, Stirlingshire, United Kingdom
Research Site
Liverpool, , United Kingdom
Research Site
London, , United Kingdom
Countries
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References
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Macdonell R, Nagels G, Laplaud DA, Pozzilli C, de Jong B, Martins da Silva A, Nicholas R, Lechner-Scott J, Gaebler JA, Agarwal S, Wang P, Yeh M, Hovenden M, Soelberg Sorensen P. Improved patient-reported health impact of multiple sclerosis: The ENABLE study of PR-fampridine. Mult Scler. 2016 Jun;22(7):944-54. doi: 10.1177/1352458515606809. Epub 2015 Oct 7.
Other Identifiers
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218MS403
Identifier Type: -
Identifier Source: org_study_id
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