Clinical trial NCT02219932: Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Keywords: Fampridine
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2014-08-19
Enrollment: 646
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Key Inclusion Criteria:

* 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

Key Exclusion Criteria:

* 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)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Proportion of Participants Achieving a Mean Improvement of ≥ 8 Points From Baseline on the Multiple Sclerosis Walking Scale (MSWS-12) Over 24 Weeks
timeFrame: Baseline to 24 weeks
Secondary outcomes:
measure: Proportion of Participants Achieving a Mean Improvement From Baseline of ≥ 15% in Timed Up and Go (TUG) Speed Over 24 Weeks
timeFrame: Baseline to Week 24
measure: Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Physical Score Over 24 Weeks
timeFrame: Baseline to Week 24
measure: Change From Baseline in Berg Balance Scale (BBS) Over 24 Weeks
timeFrame: Baseline to Week 24
measure: Change From Baseline in ABILHAND Score Over 24 Weeks
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
city: Cullman
country: United States
facility: Research site
state: Alabama
city: Phoenix
country: United States
facility: Research site
state: Arizona
city: San Diego
country: United States
facility: Research site
state: California
city: Bradenton
country: United States
facility: Research site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research site
state: Florida
city: Tampa
country: United States
facility: Research site
state: Florida
city: West Palm Beach
country: United States
facility: Research site
state: Florida
city: Lexington
country: United States
facility: Research site
state: Kentucky
city: New Bedford
country: United States
facility: Research site
state: Massachusetts
city: Detroit
country: United States
facility: Research site
state: Michigan
city: Chesterfield
country: United States
facility: Research site
state: Missouri
city: Rochester
country: United States
facility: Research site
state: New York
city: Charlotte
country: United States
facility: Research site
state: North Carolina
city: Charlotte
country: United States
facility: Research site
state: North Carolina
city: Columbus
country: United States
facility: Research site
state: Ohio
city: Roanoke
country: United States
facility: Research site
state: Virginia
city: Pleven
country: Bulgaria
facility: Research site
city: Plovdiv
country: Bulgaria
facility: Research site
city: Sofia
country: Bulgaria
facility: Research site
city: Sofia
country: Bulgaria
facility: Research site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research site
city: Sofia
country: Bulgaria
facility: Research site
city: Sofia
country: Bulgaria
facility: Research Site
city: Brno
country: Czech Republic
facility: Research site
city: Brno
country: Czech Republic
facility: Research site
city: Chocen
country: Czech Republic
facility: Research site
city: Havirov
country: Czech Republic
facility: Research site
city: Jihlava
country: Czech Republic
facility: Research site
city: Pardubice
country: Czech Republic
facility: Research site
city: Praha 2
country: Czech Republic
facility: Research site
city: Praha 5
country: Czech Republic
facility: Research site
city: Teplice
country: Czech Republic
facility: Research site
city: Helsinki
country: Finland
facility: Research site
city: Oulu
country: Finland
facility: Research site
city: Tampere
country: Finland
facility: Research site
city: Turku
country: Finland
facility: Research site
city: Gallarate
country: Italy
facility: Research Site
city: Messina
country: Italy
facility: Research site
city: Milano
country: Italy
facility: Research site
city: Napoli
country: Italy
facility: Research site
city: Rome
country: Italy
facility: Research site
city: Kaunas
country: Lithuania
facility: Research site
city: Klaipeda
country: Lithuania
facility: Research site
city: Vilnius
country: Lithuania
facility: Research site
city: Breda
country: Netherlands
facility: Research Site
city: s-Hertogenbosch
country: Netherlands
facility: Research Site
city: Sittard-Geleen
country: Netherlands
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Gdansk
country: Poland
facility: Research site
city: Grudziadz
country: Poland
facility: Research site
city: Katowice
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research site
city: Kielce
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research site
city: Krakow
country: Poland
facility: Research site
city: Lodz
country: Poland
facility: Research site
city: Olsztyn
country: Poland
facility: Research site
city: Plewiska
country: Poland
facility: Research site
city: Rzeszow
country: Poland
facility: Research site
city: Warsaw
country: Poland
facility: Research site
city: Warsaw
country: Poland
facility: Research site
city: Warsaw
country: Poland
facility: Research site
city: Kazan
country: Russian Federation
facility: Research Site
city: Kemerovo
country: Russian Federation
facility: Research site
city: Krasnoyarsk
country: Russian Federation
facility: Research site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research site
city: Nizhny Novgorod
country: Russian Federation
facility: Research Site
city: Belgrade
country: Serbia
facility: Research site
city: Kragujevac
country: Serbia
facility: Research site
city: Nis
country: Serbia
facility: Research site
city: Exeter
country: United Kingdom
facility: Research site
state: Devon
city: Plymouth
country: United Kingdom
facility: Research site
state: Devon
city: Romford
country: United Kingdom
facility: Research site
state: Essex
city: Salford
country: United Kingdom
facility: Research site
state: Greater Manchester
city: Norwich
country: United Kingdom
facility: Research site
state: Norfolk
city: Glasgow
country: United Kingdom
facility: Research site
state: Scotland
city: Chertsey
country: United Kingdom
facility: Research site
state: Surrey
city: Cardiff
country: United Kingdom
facility: Research site
state: Swansea
city: Birmingham
country: United Kingdom
facility: Research site
state: West Midlands
city: London
country: United Kingdom
facility: Research site
city: London
country: United Kingdom
facility: Research site
city: London
country: United Kingdom
facility: Research site
city: Nottingham
country: United Kingdom
facility: Research site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.