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
ENABLE
An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects With Multiple Sclerosis
1 other identifier
interventional
901
9 countries
59
Brief Summary
The primary objective of the study is to assess the effect of long-term treatment with prolonged-release fampridine (BIIB041) 10 mg twice daily on the physical component scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) as reported by treatment responders. The secondary objectives of this study are to compare the change in the PCS of the SF-36 between treatment responders and non-responders, to evaluate change from baseline in additional quality of life measures among treatment responders as well as changes from baseline in treatment responders versus non-responders and to assess the safety and tolerability of prolonged-release fampridine 10 mg twice daily.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 multiple-sclerosis
Started Feb 2012
Shorter than P25 for phase_4 multiple-sclerosis
59 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
November 23, 2011
CompletedFirst Posted
Study publicly available on registry
November 28, 2011
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedResults Posted
Study results publicly available
November 4, 2016
CompletedMarch 21, 2017
February 1, 2017
1.4 years
November 23, 2011
July 11, 2016
February 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in the Physical Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) At Months 3, 6, 9, and 12: Responders
The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the mental component summary (MCS) score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. Within-group least squares means are presented.
Baseline, Months 3, 6, 9, 12
Secondary Outcomes (34)
Change From Baseline in the PCS of the SF-36 at Months 3, 6, 9, and 12: Responders Versus Non-responders
Baseline, Months 3, 6, 9, 12
Change From Baseline in the MCS of the SF-36 At Months 3, 6, 9, and 12
Baseline, Months 3, 6, 9, 12
Change From Baseline in the Multiple Sclerosis Impact Scale (MSIS-29) Physical Score at Months 3, 6, 9, and 12
Baseline, Months 3, 6, 9, 12
Change From Baseline in MSIS-29 Psychological Score at Months 3, 6, 9, and 12
Baseline, Months 3, 6, 9, 12
Change From Baseline in the Activities Limitation Scale of the Patient-Reported Indices for Multiple Sclerosis (PRIMUS) at Months 3, 6, 9, and 12
Baseline, Months 3, 6, 9, 12
- +29 more secondary outcomes
Study Arms (1)
(BIIB041) Fampridine
EXPERIMENTALAll 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.
Interventions
Supplied as a 10 mg twice daily tablet and taken twice daily. Doses must be spaced at least 12 hours apart.
Eligibility Criteria
You may qualify if:
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations.
- 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.
You may not qualify if:
- Known allergy to pyridine-containing substances or to any of the inactive ingredients in the prolonged-release fampridine tablet.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (59)
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
Research Site
Auchenflower, Queensland, Australia
Research Site
Box Hill, Victoria, Australia
Research Site
Clayton, Victoria, Australia
Research Site
Fitzroy, Victoria, Australia
Research Site
Heidelberg, Victoria, Australia
Research Site
Brasschaat, Belgium
Research Site
Brussels, Belgium
Research Site
Diepenbeek, Belgium
Research Site
Fraiture-en-Condroz, Belgium
Research Site
Ghent, Belgium
Research Site
Liège, Belgium
Research Site
Melsbroek, Belgium
Research Site
Overpelt, Belgium
Research Site
Sijsele-Damme, Belgium
Research Site
Wilrijk, Belgium
Research Site
Copenhagen, Denmark
Research Site
Nice, Alpes-Maritimes, France
Research Site
Strasbourg, Bas-Rhin, France
Research Site
Caen, Calvados, France
Research Site
Bordeaux, Gironde 5, France
Research Site
Rennes, Ille-et-Vilaine, France
Research Site
Nantes, Loire-Atlantique 6, France
Research Site
Reims, Marne, France
Research Site
Clemont-Ferrand, Rhone, France
Research Site
Paris, Seine-Saint-Denis 14, France
Research Site
Amiens, Somme, France
Research Site
Paris, France
Research Site
Heidenheim, Bad Wuerttemberg, Germany
Research Site
Kassel, Hesse, Germany
Research Site
Oldenburg, Lower Saxony, Germany
Research Site
Münster, North Rhine-Westphalia, Germany
Research Site
Berlin, Germany
Research Site
Erbach im Odenwald, Germany
Research Site
Hamburg, Germany
Research Site
Jena, Germany
Research Site
Osnabrück, Germany
Research Site
Schwendi, Germany
Research Site
Bari, Italy
Research Site
Florence, Italy
Research Site
Milan, Italy
Research Site
Padua, Italy
Research Site
Roma, Italy
Research Site
Eindhoven, Netherlands
Research Site
Hoorn, Netherlands
Research Site
Nijmegen, Netherlands
Research Site
Tilburg, Netherlands
Research Site
Amadora, Portugal
Research Site
Coimbra, Portugal
Research Site
Lisbon, Portugal
Research Site
Porto, Portugal
Research Site
Salford, Greater Manchester, United Kingdom
Research Site
Nottingham, Northamptonshire, United Kingdom
Research Site
Glasgow, Stirlingshire, United Kingdom
Research Site
Liverpool, United Kingdom
Research Site
London, United Kingdom
Related Publications (1)
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.
PMID: 26447066BACKGROUND
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 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2011
First Posted
November 28, 2011
Study Start
February 1, 2012
Primary Completion
July 1, 2013
Study Completion
August 1, 2013
Last Updated
March 21, 2017
Results First Posted
November 4, 2016
Record last verified: 2017-02