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    Summary
    EudraCT Number:2011-002561-38
    Sponsor's Protocol Code Number:SVUHneuro002
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-02-09
    Trial results View 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 ConcernedIreland - HPRA
    A.2EudraCT number2011-002561-38
    A.3Full title of the trial
    A double blind, randomized, placebo controlled, crossover study of the effectiveness of oral fampridine in improving upper limb function in progressive multiple sclerosis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial on the effectiveness of Fampridine medication for upper limb function in people with MS.
    A.4.1Sponsor's protocol code numberSVUHneuro002
    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 SponsorSt. Vincent's University Hospital
    B.1.3.4CountryIreland
    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 supportBiogen Idec Ltd.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSt. Vincent's University Hospital
    B.5.2Functional name of contact pointDr. Christopher McGuigan
    B.5.3 Address:
    B.5.3.1Street AddressELm Park
    B.5.3.2Town/ cityDublin
    B.5.3.3Post codeDublin 4
    B.5.3.4CountryIreland
    B.5.4Telephone number0035312214179
    B.5.5Fax number0035312213842
    B.5.6E-mailC.Mcguigan@st-vincents.ie
    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 Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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.3.1Product nameFampyra
    D.3.2Product code SUB0750MIG
    D.3.4Pharmaceutical form Prolonged-release 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboProlonged-release tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Multiple sclerosis
    E.1.1.1Medical condition in easily understood language
    MS
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10063401
    E.1.2Term Primary progressive multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10053395
    E.1.2Term Progressive multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10063400
    E.1.2Term Secondary progressive multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effect of treatment with fampridine in patients with secondary progressive MS (SPMS) or primary progressive MS (PPMS) with upper limb dysfunction (as defined by a 9-HPT time of between 15-90 seconds) and Kurtzke EDSS scores in the range 4.0-7.0 on
    1. Upper limb function assessed by the nine-hole peg test (9-HPT) and the Jebson Taylor Hand Function Test (JTT).
    2. Scores of the MSIS-29 (physical), MSWS-12 and the Disabilities of the Arm, Shoulder and Hand Score (DASH)
    E.2.2Secondary objectives of the trial
    1. To assess the effect of treatment with fampridine on walking mobility assessed by the Timed 25 foot Walk (T25FW) and the Multiple Sclerosis Walking Scale (MSWS-12)6,7
    2. To determine whether response or non-response to fampridine by the T25FW can be easily determined using self reported changes in the MSWS-12 alone within 4 weeks in the course of active therapy
    3. To determine whether response or non-response to fampridine by the 9HPT or JTT can be easily determined using self reported changes in the DASH alone within 4 weeks on the course of active therapy
    4. To determine whether any relation exists between improvement / lack of improvement on the T25FW and improvement/ lack of improvement on the 9-HPT or JTT.
    5. To examine the safety of fampridine in this patient population
    6. To assess the impact of fampridine on health related quality of life in patients with multiple sclerosis (HRQOL) as measured by the SF-36 questionnaire.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with SPMS or PPMS, aged 18-70, who have Kurtzke EDSS scores in the range 4.0 to 7.0 inclusive and a walking speed with or without aids in the T25FW of 8.0 to 14.0 seconds and evidence of significant upper limb dysfunction as defined by a 9HPT of 15 – 90 seconds (dominant or non-dominant hand), will be recruited.
    E.4Principal exclusion criteria
    1) Patients with a history of seizures, significant liver dysfunction, significant renal dysfunction, significant upper or lower limb arthritis or any other disorder including cognitive dysfunction which would affect the ability to accurately complete questionnaires and give full informed consent.
    2) Patients with clinically significant upper limb ataxia or upper limb proprioceptive sensory loss, which in the opinion of the Clinician affect upper limb functional assessment.
    E.5 End points
    E.5.1Primary end point(s)
    An upper limb responder to fampridine will be defined as a patient with both of the two “on treatment” 9-HPT assessments (assessments 4 & 5 or 7 & 8) improving 20% from the average of the baseline assessments (1, 2 & 3).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The study will run for 22 weeks
    E.5.2Secondary end point(s)
    a) A secondary measure of upper limb responsiveness will be defined as a 20% improvement in from baseline in the average time taken to complete all seven tasks on the JTT “on treatment” (assessments 4 & 5 or 7 & 8) compared with baseline assessments (assessments 1,2 & 3).
    b) A mobility responder to dalfampridine will be defined as a patient with both of the two “on treatment” T25FW assessments (assessments 4 & 5 or 7 & 8) being better than the maximum of any of the four “off treatment” assessments (assessments 1, 2, 3, & 9). Otherwise the patient will be deemed a non-responder.
    c) The responders to the 9-HPT and/or JTT will be compared to the non-responders in relation to their changes in the DASH on treatment and off treatment at the baseline assessment. The change in the DASH in responders at Assessment 5 or 8 (week 10 or 20) will be compared to non-responders at that time-point.
    d) Upper limb response will be examined at the end of treatment phase 1 and repeated at the end of the trial by comparing patients receiving active drug with those receiving placebo to assess any placebo effect and allow assessment of any residual beneficial effect on those who receive fampridine in treatment phase 1 and then switch to placebo in treatment phase 2. Response will again be considered as a 20% improvement in the 9HPT in the active treatment group compared with placebo and a 20% improvement from baseline in the time taken to complete all seven tasks in the JTT. See earlier comment
    e) The responders to the T25FW will be compared to the non-responders in relation to their changes in the MSWS-12 on treatment and off treatment at the baseline assessment. The change in the MSWS-12 in responders at Assessment 5 or 8 (week 10 or 20) will be compared to non-responders at that time-point.
    f) The patients’ scores on the MSIS-29 (physical) and SF-36 will be examined in relation to the objective changes (responder/non-responder) in the 9-HPT, JTT and the T25FW.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The study will be completed at 22 weeks and all endpoints assessed.
    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 No
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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
    The end of trial will be once all patients have finished medication and completed a two-week washout period.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state80
    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)
    Expected normal treatment
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-03-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-02-16
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