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    Summary
    EudraCT Number:2014-003498-41
    Sponsor's Protocol Code Number:D-Fampr
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-08-06
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedAustria - BASG
    A.2EudraCT number2014-003498-41
    A.3Full title of the trial
    Effects of dalfampridine on mobility in the context of daily life
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of dalfampridine on mobility in the context of daily life
    A.3.2Name or abbreviated title of the trial where available
    Fampridine Study in Activities of Daily Living
    A.4.1Sponsor's protocol code numberD-Fampr
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMedical University of Vienna
    B.1.3.4CountryAustria
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMedical University of Vienna, Department of Neurology
    B.4.2CountryAustria
    B.4.1Name of organisation providing supportBiogen Idec
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWiener Pflege, PatientInnen und Patientenanwaltschaft
    B.5.2Functional name of contact pointClinical trial information desk
    B.5.3 Address:
    B.5.3.1Street AddressSchönbrunnerstraße 108, Eingang Sterkgasse
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1050
    B.5.3.4CountryAustria
    B.5.6E-mailpost@wpa.wien.gv.at
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Fampyra
    D.2.1.1.2Name of the Marketing Authorisation holderBiogen Idec
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFAMPRIDINE
    D.3.9.1CAS number 504-24-5
    D.3.9.4EV Substance CodeSUB07505MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Motor behaviour and cognition in multiple sclerosis patients
    E.1.1.1Medical condition in easily understood language
    Motor behaviour and cognition in multiple sclerosis patients
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of the study is to explore, if the use of Fampyra offers any meaningful improvement in the daily activity of patients as demanded from the public health care system in Austria.
    E.2.2Secondary objectives of the trial
    Moreover, the influence of Fampridine‐SR on MS‐related chronic fatigue and cognition will be studied. In a subset of study participants we seek to provide objective proof‐of‐concept evidence by use of functional magnetic resonance imaging (fMRI) of potential central effects of dalfampridine on remodelling of sensorimotor and cognitive cerebral networks.
    Further, by establishing fMRI correlates of behaviourally improved function, we wish to test whether fMRI could serve as a non‐invasive functional biomarker in responders to this specific drug. The proposed approach would involve both assessments of changes in sensorimotor network activity (elicited by bipedal ankle‐movements as a surrogate of the complex behaviour of gait) and in cognitive network activity (implicated in a response inhibition‐disinhibition task).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    In a subset of study participants we seek to provide objective proof‐of‐concept evidence by use of functional magnetic resonance imaging (fMRI) of potential central effects of dalfampridine on remodelling of sensorimotor and cognitive cerebral networks.
    Further, by establishing fMRI correlates of behavioural improved function, we wish to test whether fMRI could serve as a non‐invasive functional biomarker in responders to this specific drug.
    1.) Motor behaviour
    a) Does a 6 weeks treatment period with dalfampridine alters sensorimotor brain activations?
    b) Does a 6 weeks treatment period with dalfampridine improves motor performance?
    Clinical improvement of motor performance related to medical intervention varies between patients.
    Our primary assumption therefore is that this effect is mediated by improvements of central motor control by dalfampridine in a subset of patients, i.e. responders with improved motor performance. Most likely these improvements will appear as medication related fMRI signal with increases indicating enhancement of compensatory brain activation. Since a full reconstitution of the motor performance cannot be expected, a finding of medication related signal decrease seems unlikely, unless this might indicate more efficient signal processing.
    With the behavioural measures described, correlations between fMRI signals and motor performance will be possible.
    2.) Cognition
    a) Does a 6 weeks treatment period with dalfampridine alters cognitive brain activations?
    b) Does a 6 weeks treatment period with dalfampridine improves cognitive performance?

    30 MS patients will be studied.

    1.) The inclusion criteria for patients undergoing the fMRI substudies follow the core clinical study.
    2.) Experimental course:
    ‐ Appropriate patients will undergo fMRI baseline testing in addition to other clinical procedures (defined specifically in the study protocol)
    ‐ Second fMRI in addition to other clinical procedures (defined specifically in the study protocol) will be performed after 6 weeks of medication
    3.) fMRI:
    ‐ cognitive fMRI: given the experience with and stability of this paradigm and multicentric data obtained at 5 European sites within the MAGNIMS (Magnetic Resonance Imaging in Multiple Sclerosis) network attesting to the feasibility of multicentric data acquisition (Enzinger et al., personal communication), a go/no‐go task will be employed.
    The Go/NoGo task, represented by two different stimuli (cross vs. target), is a discrimination task including within and between pseudo‐randomized presentation of (target) stimuli (figure 1) and has proven feasible in MS patients across all phenotypes in own studies (see figure 2 for a sample of group mean activation in 40 MS patients and 40 healthy controls). Via a button response box responses are given to targets predefined to every sequence using the index finger. Different inter‐stimulus intervals serve to vary task severity. The frontoparietal network commonly activated by the task includes pre‐SMA, with indication of additional activation of the dorso‐lateral prefrontal cortex and parietal areas in MS patients.
    Response control combines several domains potentially affected by the MS disease, such as cognitive, perceptual (e.g. ignoring of distractors) and motor (e.g. reaction inhibition) domains. The ability to suppress irrelevant or displacing stimuli is considered as a fundamental executive function (working memory). Also, in the context of MS, response inhibition seems to be a relevant marker for sustained attention.
    The paradigm is implemented as block design, with 10 active blocks (30 seconds each) and 9 interspersed resting phases (15 seconds each). The duration of the experiment is about 8 minutes.
    motor fMRI: a dedicated purpose‐built fMRI compatible apparatus will be used which allows highly controlled bipedal ankle movements resembling actual walking movements (kindly provided by the Department of Neurology, Medical University Graz).
    E.3Principal inclusion criteria
    Patients over 18 years with multiple sclerosis and an EDSS between 4 and 7, suffering from gait disturbance will be included. Only patients who have been identified as responders during a previous named patient programme and were refused to get reimbursement by the public health care system in Austria will be included.
    E.4Principal exclusion criteria
    Exclusion criteria will be a treatment with Fampridine less then 6 weeks before the start of the study, previously identified non‐response to Fampridine and an age below 18 years.
    E.5 End points
    E.5.1Primary end point(s)
    Changes in gait mobility as assessed by GTX3+ accelerometers after 6 weeks
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 6 weeks
    E.5.2Secondary end point(s)
    Changes in basic and instrumental activities of daily life as assessed by the COPM and
    MS specific Fatigue Scale and Fatigue Severity Scale

    fMRI activity and connectivity changes
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baesline vs. 6 weeks
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    If the number of drop outs is so high that proper completion can be realistically be expected.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 51
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state51
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients will be treated for a period of 6 months with special emphasis on ensuring continuation of the patients´ typical daily activities and absence of change regarding other activities/interventions possibly interfering with the clinical status. Patients with significant improvement in ADLs will be supported with a medical request to get the medication reimbursed by the public insurance on an individual basis after the end of the study.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-02
    P. End of Trial
    P.End of Trial StatusOngoing
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