Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis
ENHANCE
A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects With Multiple Sclerosis (ENHANCE)
2 other identifiers
interventional
646
11 countries
87
Brief Summary
The primary objective is to determine whether prolonged-release fampridine (10 mg twice daily) has a clinically meaningful effect on participant-reported walking ability over a 24-week study period. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 multiple-sclerosis
Started Sep 2014
Shorter than P25 for phase_3 multiple-sclerosis
87 active sites
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
First Submitted
Initial submission to the registry
August 18, 2014
CompletedFirst Posted
Study publicly available on registry
August 19, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedResults Posted
Study results publicly available
March 27, 2017
CompletedMarch 27, 2017
January 1, 2017
1.4 years
August 18, 2014
February 6, 2017
February 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Participants Achieving a Mean Improvement of ≥ 8 Points From Baseline on the Multiple Sclerosis Walking Scale (MSWS-12) Over 24 Weeks
MSWS-12 is a participant self-assessment of the walking limitations due to MS during the past 2 weeks. It contains 12 items that measure the impact of MS on walking. Items are summed to generate a total score and transformed to a scale with a range of 0 to 100, where higher scores indicate greater impact on walking. A responder is defined as a participant with a mean improvement of at least 8 points over 24 weeks compared to baseline. Baseline is defined as the mean at Screening and Day 1 visits. If a participant has a mean MSWS-12 score of \< 0.5 over the double-blind period, and a baseline MSWS-12 score of \< 8 points, the participant is counted as a responder. A participant who indicates they cannot walk at all on MSWS-12 during any double-blind visit, and who shows severe disability and an inability to walk on other efficacy assessments is counted as a non-responder. Estimated proportion obtained from binomial proportions.
Baseline to 24 weeks
Secondary Outcomes (4)
Proportion of Participants Achieving a Mean Improvement From Baseline of ≥ 15% in Timed Up and Go (TUG) Speed Over 24 Weeks
Baseline to Week 24
Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Physical Score Over 24 Weeks
Baseline to Week 24
Change From Baseline in Berg Balance Scale (BBS) Over 24 Weeks
Baseline to Week 24
Change From Baseline in ABILHAND Score Over 24 Weeks
Baseline to Week 24
Study Arms (2)
Fampridine 10 mg BID
EXPERIMENTALProlonged-release fampridine 10 mg twice daily (BID) for up to 24 weeks
Placebo
PLACEBO COMPARATORMatched placebo 10 mg BID for up to 24 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Must have a diagnosis of primary-progressive, secondary-progressive, progressive-relapsing, or relapsing-remitting MS per revised McDonald Committee criteria \[McDonald 2001; Polman 2005\] as defined by Lublin and Reingold \[Lublin and Reingold 1996\] of at least 3 months duration
- Must have an Expanded Disability Status Scale (EDSS) score of 4 to 7, inclusive
- Must have walking impairment, as deemed by the Investigator
You may not qualify if:
- History of human immunodeficiency virus (HIV)
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (87)
Research site
Cullman, Alabama, 35058, United States
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Phoenix, Arizona, 85013, United States
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San Diego, California, 92108, United States
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Bradenton, Florida, 34205, United States
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Orlando, Florida, 32806, United States
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Tampa, Florida, 33612, United States
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Tampa, Florida, 33634, United States
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West Palm Beach, Florida, 33407, United States
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Lexington, Kentucky, 40513, United States
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New Bedford, Massachusetts, 02740, United States
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Detroit, Michigan, 48201, United States
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Chesterfield, Missouri, 63017, United States
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Rochester, New York, 14642, United States
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Charlotte, North Carolina, 28207, United States
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Charlotte, North Carolina, 28210, United States
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Columbus, Ohio, 43210, United States
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Roanoke, Virginia, 24018, United States
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Pleven, 5800, Bulgaria
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Plovdiv, 4002, Bulgaria
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Sofia, 1113, Bulgaria
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Sofia, 1142, Bulgaria
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Sofia, 1407, Bulgaria
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Sofia, 1431, Bulgaria
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Sofia, 1606, Bulgaria
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Sofia, 1797, Bulgaria
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Brno, 62500, Czechia
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Brno, 65691, Czechia
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Choceň, 56501, Czechia
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Havířov, 73601, Czechia
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Jihlava, 58633, Czechia
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Pardubice, 53203, Czechia
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Prague, 12808, Czechia
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Prague, 15006, Czechia
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Teplice, 41501, Czechia
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Helsinki, 00100, Finland
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Oulu, 90220, Finland
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Tampere, 33520, Finland
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Turku, 20520, Finland
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Gallarate, Italy
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Messina, 98121, Italy
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Milan, 20133, Italy
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Napoli, 80138, Italy
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Rome, 00189, Italy
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Kaunas, 50009, Lithuania
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Klaipėda, 92288, Lithuania
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Vilnius, 08661, Lithuania
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's-Hertogenbosch, 5223, Netherlands
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Breda, 4818, Netherlands
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Sittard-Geleen, 6162, Netherlands
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Bialystok, 15-276, Poland
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Gdansk, 80-803, Poland
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Grudziądz, 86-300, Poland
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Katowice, 40-595, Poland
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Katowice, 40-749, Poland
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Katowice, 40-752, Poland
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Kielce, 25-726, Poland
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Krakow, 31-505, Poland
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Krakow, 31-637, Poland
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Lodz, 90-324, Poland
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Olsztyn, 10-561, Poland
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Plewiska, 62064, Poland
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Rzeszów, 35055, Poland
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Warsaw, 00-669, Poland
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Warsaw, 01-697, Poland
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Warsaw, 04-749, Poland
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Kazan', 420021, Russia
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Kemerovo, 650066, Russia
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Krasnoyarsk, 660037, Russia
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Moscow, 127015, Russia
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Moscow, 129128, Russia
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Nizhny Novgorod, 60155, Russia
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Belgrade, 11000, Serbia
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Kragujevac, 34000, Serbia
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Niš, 18000, Serbia
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Exeter, Devon, EX2 5DW, United Kingdom
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Plymouth, Devon, PL6 8DH, United Kingdom
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Romford, Essex, RM7 0AG, United Kingdom
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Salford, Greater Manchester, M6 8HD, United Kingdom
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Norwich, Norfolk, NR4 7UY, United Kingdom
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Glasgow, Scotland, G51 4TF, United Kingdom
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Chertsey, Surrey, KT16 0PZ, United Kingdom
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Cardiff, Swansea, SA6 6NL, United Kingdom
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Birmingham, West Midlands, B15 2WB, United Kingdom
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London, E1 2AT, United Kingdom
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London, NW3 2QG, United Kingdom
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London, WC1N 3BG, United Kingdom
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Nottingham, NG7 2UH, United Kingdom
Related Publications (1)
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.
PMID: 30535670DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Biogen Study Medical Director
- Organization
- Biogen
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2014
First Posted
August 19, 2014
Study Start
September 1, 2014
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
March 27, 2017
Results First Posted
March 27, 2017
Record last verified: 2017-01