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    Clinical Trial Results:
    Prolonged-release oral Fampridine in Multiple Sclerosis: effects on clinical, neurophysiological and quantified gait analysis parameters. A cross-over, double-blinded, placebo-controlled study.

    Summary
    EudraCT number
    		 2012-005076-34
    Trial protocol
    		 BE  
    Global end of trial date
    29 Sep 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Apr 2021
    First version publication date
    03 Apr 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BEL-FMP-12-10325
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cliniques universitaires Saint-Luc
    Sponsor organisation address
    Avenue Hippocrate 10, Brussels, Belgium, 1200
    Public contact
    Souraya ElSankari, Cliniques Universitaires Saint-Luc, Neurologie, 00 3227641932, souraya.elsankari@uclouvain.be
    Scientific contact
    Souraya ElSankari, Cliniques Universitaires Saint-Luc, Neurologie, 00 3227641932, souraya.elsankari@uclouvain.be
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Sep 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Sep 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Sep 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to assess the effect of treatment with prolonged-release fampridine 10 mg twice, on the quantified gait analysis parameters (kinematics, dynamics, mechanical work).
    Protection of trial subjects
    All observed adverse events regardless of treatment group or suspected relationship to the IP were reported.
    Background therapy
    		 Patients meeting the inclusion criteria first underwent a 4-week run-in period during which they were treated by 10 mg PR-fampridine twice a day, to test for the responder status. A responder was defined as a 10% improvement at the timed 25-foot walk test (T25fWT) and any improvement in the multiple sclerosis walking scale (MSWS-12) at the end of the 4-week run-in period. Non-responders were subsequently excluded from the study. Responders then underwent a 2-week wash-out period before entering the main phase of the study. Included participants were randomly allocated (1:1 ratio) by a computer software to receive either 6 weeks of PR-fampridine (Fampyra®, Biogen; 10mg b.i.d.) followed by a 2-week wash-out period and a 6-week course of placebo (manufactured to appear identical to Fampyra), or the other way-round. Participants, therapists and assessors were blinded to the condition. Participants were assessed before (w6) and after (w12) the first treatment period and again before (w14) and after the second period (w20).
    Evidence for comparator
    		 This is a blinded placebo controlled cross-over study aiming to assess the effects of IP on patients reported outcomes and gait analysis.
    Actual start date of recruitment
    01 Jan 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    24
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between February 2013 and April 2015, 39 patients from the MS consultation of the neurology department of our institution Cliniques Universitaires Saint Luc were selected for inclusion. After 4 weeks, fifteen patients were considered non-responding and withdrawn from the rest of the study. . Only 24 patients were included and randomized.

    Pre-assignment
    Screening details
    		 Patients with McDonald's criteria were eligible if they were between 18 and 65 years of age, had a subjective complaint of inability to walk, and had an EDSS score of 6 or less.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor
    Blinding implementation details
    According to GCP rules.

    Arms
    Arm title
    		 Fampyra versus Placebo
    Arm description
    		 10 Randomized to receive IP during the first phase and placebo during 2nd phase 14 placebo treatment during first phase, then cross over after wash out period, and IP treated
    Arm type
    		 Cross over

    Investigational medicinal product name
    Fampridine
    Investigational medicinal product code
    BIIB041
    Other name
    Pharmaceutical forms
    Prolonged-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2 pills per day

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2 pills per day

    Number of subjects in period 1
    		Fampyra versus Placebo
    Started
    24
    Completed
    23
    Not completed
    1
         Patient convenience
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 24 24
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 24 24
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 46 ± 10 -
    Gender categorical
    Units: Subjects
        Female
    		 12 12
        Male
    		 12 12

    End points

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    End points reporting groups
    Reporting group title
    Fampyra versus Placebo
    Reporting group description
    		 10 Randomized to receive IP during the first phase and placebo during 2nd phase 14 placebo treatment during first phase, then cross over after wash out period, and IP treated

    Primary: External work change under treatment

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    End point title
    		 External work change under treatment [1]
    End point description
    The primary endpoint was to indicate a difference in Wext under treatment with PR-fampridine versus placebo. The expected minimal detectable change15 was assumed to be 15% for the primary endpoint.
    End point type
    Primary
    End point timeframe
    6 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: For each outcome, repeated measures ANCOVAs were applied, with the treatment being the explicative variable and the within-subject differences between baselines (prePR-fampridine and prePlacebo) being the covariate.16Intention-to-treat (ITT) analysis was performed, including all participants assessed at w6. For missing data, the ‘last observation carried forward’ strategy was applied.
    End point values
    		 Fampyra versus Placebo
    Number of subjects analysed
    23
    Units: J.kg-1.m-1
        number (not applicable)
    -0.04
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events were screened at each visit (screening, start and end of both phases A and B), from first patient inclusion and until the last patient end of study visit.
    Adverse event reporting additional description
    No adverse event were reported in our population. Patients screened but non included were excluded because they were considered as non responders according to protocol definition.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    3.0
    Reporting groups
    Reporting group title
    Fampyra versus Placebo
    Reporting group description
    		 *IP (Fampridine) treatment during first phase, then cross over after wash out period, and placebo treated *Placebo treatment during first phase, then cross over after wash out period, and IP treated

    Serious adverse events
    		 Fampyra versus Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 23 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Fampyra versus Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 23 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There were no adverse events during the randomisation period

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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