Exploratory Study to Assess the Effect of Fampridine (BIIB041) on Walking Ability and Balance in Participants With Multiple Sclerosis.
MOBILE
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Exploratory Study to Assess the Effect of Treatment With Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Walking Ability and Balance in Subjects With Multiple Sclerosis
2 other identifiers
interventional
132
6 countries
23
Brief Summary
The objectives of this study in Multiple Sclerosis (MS) participants treated with prolonged-released fampridine (BIIB041) 10 mg twice daily compared with participants treated with placebo are to assess the effect over 24 weeks on the following parameters to explore endpoints for the Phase 3 study: self-assessed walking disability, dynamic and static balance, subjective impression of well-being, and participants' global impression of change in walking . Another purpose of this study is to evaluate the safety and tolerability of prolonged-release fampridine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 multiple-sclerosis
Started Aug 2012
Shorter than P25 for phase_2 multiple-sclerosis
23 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
May 10, 2012
CompletedFirst Posted
Study publicly available on registry
May 14, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedJanuary 9, 2017
January 1, 2017
1 year
May 10, 2012
January 5, 2017
Conditions
Outcome Measures
Primary Outcomes (7)
Change from baseline in self-assessed walking disability as reported on the Multiple Sclerosis Walking Scale-12 (MSWS-12)
Day 1, up to 24 weeks
Change from baseline in static balance as assessed by Berg Balance Scale (BBS)
Day 1, up to 24 weeks
Change from baseline in dynamic balance as assessed by the Timed Up and Go (TUG) scale)
Day 1, up to 24 weeks
Change from baseline in subjective impression of well-being measured by Multiple Sclerosis Impact Scale-29 (MSIS-29)
Day 1, up to 24 weeks
Change from baseline in subjective impression of well-being measured by Euro Quality of Life-5D (EQ-5D)
Day 1, up to 24 weeks
Participant's global impression of change in walking as reported on the Patient Global Impression of Change Scale (PGIC)
Day 1, up to 24 weeks
Summary of Participants with adverse events (AEs) and serious adverse events (SAEs)
Day 1 Up to 26 weeks
Study Arms (2)
Fampridine-PR
EXPERIMENTALProlonged-Release Fampridine (Fampridine-PR) 10 mg twice daily (every 12 hours) for up to 24 weeks.
Placebo
PLACEBO COMPARATORMatched placebo twice daily (every 12 hours) for up to 24 weeks.
Interventions
10 mg twice daily, given orally. Doses of study treatment must be spaced at least 12 hours apart. If a dose of study treatment is delayed or missed, the participant should not dose again until their next scheduled dose. Tablets must be swallowed whole and should be taken without food.
Twice daily, given orally. Doses of study treatment must be spaced at least 12 hours apart. If a dose of study treatment is delayed or missed, the participant should not dose again until their next scheduled dose. Tablets must be swallowed whole and should be taken without food.
Eligibility Criteria
You may qualify if:
- Must be able to understand the purpose and risk of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations
- Diagnosis of primary-progressive, secondary progressive, progressive-remitting, or relapsing-remitting Multiple Sclerosis of at least 3-month duration
- EDSS 4 to 7
- Female patients 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
- Must be 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 (BIIB041) tablet
- Any history of seizure, epilepsy, or other convulsive disorder, with the exception of febrile seizures in childhood
- An estimated creatinine clearance (CrCl) of \<80 mL/minute (using the Cockcroft-Gault formula)
- Known history of Human Immunodeficiency Virus, hepatitis C, or hepatitis B. Subjects who have evidence of prior hepatitis infection that has been serologically confirmed as resolved based on previous testing documented in the subjects' medical history are not excluded from study participation
- History of malignant disease including solid tumors and hematologic malignancies (with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured) within the 5 years prior to the Screening Visit, or at any time during the screening period
- Onset of MS exacerbation within the 60 days prior to the Screening Visit, or at any time during the screening period
- History of any major surgical intervention (with the exception of skin biopsy) within the 30 days prior to the Screening Visit, or at any time during the screening period
- Any non-MS-related condition or factor (as determined by the Investigator) that is likely to interfere with walking ability including, but not limited to, previous major surgery of the foot, leg, or hip; any significant trauma; or known peripheral neuropathy of the lower limb
- Presence of pulmonary disease including, but not limited to, chronic obstructive pulmonary disease that could impede the subject's daily activities (as determined by the Investigator)
- Presence of any psychiatric disorder, including clinical depression, that is likely to interfere with the subject's participation in the study (as determined by the Investigator)
- Uncontrolled hypertension (as determined by the Investigator) at the Screening Visit, any time during the screening period, or Day 1
- History of any clinically significant endocrinologic, hematologic, immunologic, metabolic, urologic, neurologic (except for MS, but including events indicative of a potentially lower seizure threshold), dermatologic, or other major disease (as determined by the Investigator)
- Clinically significant abnormal laboratory values (as determined by the Investigator)
- A Body Mass Index ≥40
- Use of off label MS treatment including rituximab, alemtuzumab, daclizumab, or antibody (except natalizumab) within the 3 months prior to the Screening Visit, or any time during the screening period, or scheduled use during study participation
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (23)
Research Site
Ath, Belgium
Research Site
Bruges, Belgium
Research Site
Brussels, Belgium
Research Site
Leuven, Belgium
Research Site
Yvoir, Belgium
Research Site
Halifax, Nova Scotia, Canada
Research Site
London, Ontario, Canada
Research Site
Gatineau, Quebec, Canada
Research Site
Greenfield Park, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Ancona, AN, Italy
Research Site
Brescia, BS, Italy
Research Site
Empoli, FI, Italy
Research Site
Palermo, PA, Italy
Research Site
Roma, RM, Italy
Research Site
Breda, Netherlands
Research Site
Sittard-Geleen, Netherlands
Research Site
Gothenburg, Sweden
Research Site
Stockholm, Sweden
Research Site
Edgbaston, Birmingham, United Kingdom
Research Site
Poole, Dorset, United Kingdom
Research Site
Swansea, Glamorgan, United Kingdom
Research Site
London, United Kingdom
Related Publications (1)
Hupperts R, Lycke J, Short C, Gasperini C, McNeill M, Medori R, Tofil-Kaluza A, Hovenden M, Mehta LR, Elkins J. Prolonged-release fampridine and walking and balance in MS: randomised controlled MOBILE trial. Mult Scler. 2016 Feb;22(2):212-21. doi: 10.1177/1352458515581436. Epub 2015 Apr 28.
PMID: 25921050BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2012
First Posted
May 14, 2012
Study Start
August 1, 2012
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
January 9, 2017
Record last verified: 2017-01