Multiple SclerosisPhase 2MOBILENCT01597297
Exploratory Study to Assess the Effect of Fampridine (BIIB041) on Walking Ability and Balance in Participants With Multiple Sclerosis.
A Phase 2 study testing BIIB041 (PR Fampridine) in people with Multiple Sclerosis, run by Biogen at 23 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- BIIB041 (PR Fampridine)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 23 sitesin 6 countries
- Study dates
- Aug 2012to Aug 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 32Show fewer
- 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
- Use of mitoxantrone or cyclophosphamide within the 3 months prior to the Screening Visit, or any time during the screening period, or scheduled use during study participation
- Initiation of natalizumab treatment or any change in the subject's dose or regimen of natalizumab, within the 3 months prior to the Screening Visit, or at any time during the screening period
- Initiation of treatment with, or any change in the subject's dose or regimen of, interferon β 1b, interferon β-1a, fingolimod, or glatiramer acetate within the 30 days prior to the Screening Visit, or at any time during the screening period
- Pulsed steroid treatment within the 60 days prior to the Screening Visit, or at any time during the screening period
- Any change in the subject's medication dose or regimen for the treatment of fatigue or depression within the 30 days prior to the Screening Visit, or at any time during the screening period
- Any change in prophylactic treatment for pain with antidepressants or anticonvulsants prescribed for this purpose within 30 days prior to the Screening Visit, or at any time during the screening period
- Any change in the subject's dose or regimen of antispastic agents within the 7 days prior to the Screening Visit, or at any time during the screening period
- Treatment with an investigational drug or approved therapy for investigational use within the 30 days (or 7 half-lives, whichever is longer) prior to the Screening Visit, or at any time during the screening period
- Treatment with 4-AP or 3,4-diaminopyridine (DAP) in any formulation within the 30 days prior to the Screening Visit, or at any time during the screening period
- History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to the Screening Visit, or at any time during the screening period
- Female subjects who are currently pregnant or who are considering becoming pregnant while participating in the study. Female subjects of childbearing potential who have a positive pregnancy test at either the Screening Visit or Day 1 may not participate in this study
- Female subjects who are currently breastfeeding
- Inability to comply with study requirements
- Current enrollment in any other drug, biological, device, or clinical study
- Previous participation in this study
- Any other reason, in the opinion of the Investigator, which would disqualify the subject from participation in this study or make the subject unsuitable for enrollment
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
23 sites in 6 countries.
23 sites in 6 countries
Belgium5 sites
Research Site
Ath
Research Site
Bruges
Research Site
Brussels
Research Site
Leuven
Research Site
Yvoir
Canada5 sites
Research Site
Gatineau, Quebec
Research Site
Greenfield Park, Quebec
Research Site
Halifax, Nova Scotia
Research Site
London, Ontario
Research Site
Montreal, Quebec
Italy5 sites
Research Site
Ancona, AN
Research Site
Brescia, BS
Research Site
Empoli, FI
Research Site
Palermo, PA
Research Site
Roma, RM
United Kingdom4 sites
Research Site
Edgbaston, Birmingham
Research Site
London
Research Site
Poole, Dorset
Research Site
Swansea, Glamorgan
About this study
Official title: 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
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.
Read the detailed description
The primary objective of the study is to explore the effect of prolonged-released fampridine 10 mg twice daily in patients with Multiple Sclerosis with walking disability. The change of walking ability will be measured using Multiple Sclerosis Walking Scale-12 (MSWS-12) to further elucidate the clinical relevance of changes over 24 weeks treatment duration. Another purpose of this study is to evaluate the safety and tolerability of prolonged-release fampridine.
Approximately 120 patients MS will be randomized over 20 sites worldwide. Duration of patient's participation in the study will be approximately 28 weeks.
- Conditions
- Multiple Sclerosis
- Being tested
- BIIB041 (PR Fampridine), Placebo
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB041 (PR Fampridine)Drug
Also called Fampridine-PR (prolonged-release), Dalfampridine-ER (extended-release), FAMPYRA®, AMPYRA®
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Fampridine-PR | Experimental | Prolonged-Release Fampridine (Fampridine-PR) 10 mg twice daily (every 12 hours) for up to 24 weeks. Receives: Drug: BIIB041 (PR Fampridine) |
| Placebo | Placebo comparator | Matched placebo twice daily (every 12 hours) for up to 24 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in self-assessed walking disability as reported on the Multiple Sclerosis Walking Scale-12 (MSWS-12)
Measured: Day 1, up to 24 weeks
Change from baseline in static balance as assessed by Berg Balance Scale (BBS)
Measured: Day 1, up to 24 weeks
Change from baseline in dynamic balance as assessed by the Timed Up and Go (TUG) scale)
Measured: Day 1, up to 24 weeks
Change from baseline in subjective impression of well-being measured by Multiple Sclerosis Impact Scale-29 (MSIS-29)
Measured: Day 1, up to 24 weeks
Change from baseline in subjective impression of well-being measured by Euro Quality of Life-5D (EQ-5D)
Measured: 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)
Measured: Day 1, up to 24 weeks
Summary of Participants with adverse events (AEs) and serious adverse events (SAEs)
Measured: Day 1 Up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01597297
- Sponsor's protocol ID
- 218MS205
- Other IDs
- 2012-000368-90
- Acronym
- MOBILE
- Status last verified
- Jan 2017
- First submitted
- 10 May 2012
- Last updated
- 9 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25921050
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01597297
- Acronym / sponsor ID
- MOBILE / 218MS205
- Conditions
- Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 14 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective of the study is to explore the effect of prolonged-released fampridine 10 mg twice daily in patients with Multiple Sclerosis with walking disability. The change of walking ability will be measured using Multiple Sclerosis Walking Scale-12 (MSWS-12) to further elucidate the clinical relevance of changes over 24 weeks treatment duration. Another purpose of this study is to evaluate the safety and tolerability of prolonged-release fampridine.
Approximately 120 patients MS will be randomized over 20 sites worldwide. Duration of patient's participation in the study will be approximately 28 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fampridine-PR | Experimental | Drug: BIIB041 (PR Fampridine)Prolonged-Release Fampridine (Fampridine-PR) 10 mg twice daily (every 12 hours) for up to 24 weeks. |
| Placebo | Placebo comparator | Other: PlaceboMatched placebo twice daily (every 12 hours) for up to 24 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (32 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIIB041 (PR Fampridine)Also: Fampridine-PR (prolonged-release), Dalfampridine-ER (extended-release), FAMPYRA®, AMPYRA®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. | Drug | Fampridine-PR |
| PlaceboTwice 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. | Other | Placebo |
Primary outcome
Change from baseline in self-assessed walking disability as reported on the Multiple Sclerosis Walking Scale-12 (MSWS-12)
Time frame: Day 1, up to 24 weeks
Change from baseline in static balance as assessed by Berg Balance Scale (BBS)
Time frame: Day 1, up to 24 weeks
Change from baseline in dynamic balance as assessed by the Timed Up and Go (TUG) scale)
Time frame: Day 1, up to 24 weeks
Change from baseline in subjective impression of well-being measured by Multiple Sclerosis Impact Scale-29 (MSIS-29)
Time frame: Day 1, up to 24 weeks
Change from baseline in subjective impression of well-being measured by Euro Quality of Life-5D (EQ-5D)
Time frame: 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)
Time frame: Day 1, up to 24 weeks
Summary of Participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: Day 1 Up to 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
- Background: PubMed 25921050Hupperts 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.
- EudraCT Tabulated ResultLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
23 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BIIB041 (PR Fampridine) in people with Multiple Sclerosis, run by Biogen at 23 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Belgium, Canada, Italy, United Kingdom, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in self-assessed walking disability as reported on the Multiple Sclerosis Walking Scale-12 (MSWS-12) (time frame: Day 1, up to 24 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01597297, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2017.