Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis
NCT ID: NCT02219932
Last Updated: 2017-03-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
646 participants
INTERVENTIONAL
2014-09-30
2016-02-29
Brief Summary
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The secondary objectives are: to determine whether prolonged-release fampridine 10 mg taken twice daily (BID) has a clinically meaningful effect on dynamic and static balance, physical impact of multiple sclerosis (MS), and upper extremity function over a 24-week study period; to evaluate criteria for early assessment of response to fampridine that can predict clinically meaningful benefits in walking ability and balance; to assess the safety and tolerability of prolonged-release fampridine 10 mg twice daily over a 24-week treatment period.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Fampridine 10 mg BID
Prolonged-release fampridine 10 mg twice daily (BID) for up to 24 weeks
fampridine
Placebo
Matched placebo 10 mg BID for up to 24 weeks
Placebo
Matched placebo
Interventions
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fampridine
Placebo
Matched placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have an Expanded Disability Status Scale (EDSS) score of 4 to 7, inclusive
* Must have walking impairment, as deemed by the Investigator
Exclusion Criteria
* Presence of acute or chronic hepatitis. Subjects who have evidence of prior hepatitis infection that has been serologically confirmed as resolved are not excluded from study participation
* Known allergy to fampridine, pyridine-containing substances, or any of the inactive ingredients in the prolonged-release fampridine tablet
* Creatinine clearance (CrCl) of \<80 mL/min
* History of malignant disease
* Presence of pulmonary disease
* A body mass index (BMI) ≥40 (BMI formula: BMI = mass \[kg\]/\[height(m)\]2)
18 Years
70 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
Cullman, Alabama, United States
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Phoenix, Arizona, United States
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San Diego, California, United States
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Bradenton, Florida, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Lexington, Kentucky, United States
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New Bedford, Massachusetts, United States
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Detroit, Michigan, United States
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Chesterfield, Missouri, United States
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Rochester, New York, United States
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Charlotte, North Carolina, United States
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Charlotte, North Carolina, United States
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Columbus, Ohio, United States
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Roanoke, Virginia, United States
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Pleven, , Bulgaria
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Brno, , Czechia
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Brno, , Czechia
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Choceň, , Czechia
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Havířov, , Czechia
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Jihlava, , Czechia
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Pardubice, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Teplice, , Czechia
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Helsinki, , Finland
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Oulu, , Finland
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Tampere, , Finland
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Turku, , Finland
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Gallarate, , Italy
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Messina, , Italy
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Milan, , Italy
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Napoli, , Italy
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Rome, , Italy
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Kaunas, , Lithuania
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Klaipėda, , Lithuania
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Vilnius, , Lithuania
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's-Hertogenbosch, , Netherlands
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Breda, , Netherlands
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Sittard-Geleen, , Netherlands
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Bialystok, , Poland
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Gdansk, , Poland
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Grudziądz, , Poland
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Katowice, , Poland
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Katowice, , Poland
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Katowice, , Poland
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Kielce, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Olsztyn, , Poland
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Plewiska, , Poland
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Rzeszów, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Kazan', , Russia
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Kemerovo, , Russia
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Krasnoyarsk, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Belgrade, , Serbia
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Kragujevac, , Serbia
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Niš, , Serbia
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Exeter, Devon, United Kingdom
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Plymouth, Devon, United Kingdom
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Romford, Essex, United Kingdom
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Salford, Greater Manchester, United Kingdom
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Norwich, Norfolk, United Kingdom
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Glasgow, Scotland, United Kingdom
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Chertsey, Surrey, United Kingdom
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Cardiff, Swansea, United Kingdom
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Birmingham, West Midlands, United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Nottingham, , United Kingdom
Countries
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References
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Hobart J, Ziemssen T, Feys P, Linnebank M, Goodman AD, Farrell R, Hupperts R, Blight AR, Englishby V, McNeill M, Chang I, Lima G, Elkins J; ENHANCE study investigators. Assessment of Clinically Meaningful Improvements in Self-Reported Walking Ability in Participants with Multiple Sclerosis: Results from the Randomized, Double-Blind, Phase III ENHANCE Trial of Prolonged-Release Fampridine. CNS Drugs. 2019 Jan;33(1):61-79. doi: 10.1007/s40263-018-0586-5.
Other Identifiers
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2013-003600-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
218MS305
Identifier Type: -
Identifier Source: org_study_id
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