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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2012-000368-90
    Sponsor's Protocol Code Number:218MS205
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-08-06
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-000368-90
    A.3Full title of the trial
    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 (MOBILE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prolonged-Release Fampridine Effect on Walking Ability and Balance in Multiple Sclerosis
    A.4.1Sponsor's protocol code number218MS205
    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 SponsorBiogen Idec Research Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBiogen Idec Research Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiogen Idec Research Limited
    B.5.2Functional name of contact pointNot Available
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House, 70 Norden Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4AY
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailmobile@biogenidec.com
    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 Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameFampridine
    D.3.2Product code BIIB041
    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.3.9.2Current sponsor codeBIIB041
    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 placeboCoated 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
    Multiple Sclerosis
    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 15.0
    E.1.2Level PT
    E.1.2Classification code 10028245
    E.1.2Term 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
    The objectives of this study in MS subjects treated with prolonged-release fampridine 10 mg twice daily compared with subjects treated with placebo are:
    To assess the effect of prolonged-release fampridine 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, subjects’ global impression of change in walking
    To evaluate the safety and tolerability of prolonged-release fampridine.
    E.2.2Secondary objectives of the trial
    Not Applicable
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenomic Assessments (Optional)
    Investigator participation in pharmacogenomic assessment is optional and contingent upon approval by his/her ethics committee or Institutional Review Board (IRB). If participating, the potential subjects will also be provided with the option to decline the pharmacogenomic assessment without affecting participation in the main study. Informed consent will be documented by the Investigator and recorded on the CRF. If the Investigator is not participating or the pharmacogenomic assessment is not approved by his/her ethics committee/IRB, the relevant section of the informed consent form (ICF) will not be applicable to that site.
    Whole blood samples for DNA testing will be collected at baseline with subject consent (requires written informed consent). Experience with treatment in MS shows that there is heterogeneity in clinical response, and some of the heterogeneity may be associated with genetic variation in patients. The pharmacogenomic analysis will explore identification of specific genetic polymorphisms associated with study treatment response.
    DNA may be used for genome-wide or candidate gene single nucleotide polymorphism (SNP) analyses. Allelic variants at SNP loci will be tested for association with safety and efficacy measurements from the study.
    Refer to Section 4.2 for the timing of assessments and to Section 4.3 for additional detail regarding the assessments.
    E.3Principal inclusion criteria
    To be eligible to participate in this study, candidates must meet the following eligibility criteria at the Screening Visit or at the timepoint specified in the individual eligibility criterion listed:
    1. Ability to understand the purpose and risks 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.
    2. Male or female subjects must be 18 to 70 years old, inclusive, at the time of informed consent.
    3. Must have a diagnosis of primary-progressive, secondary-progressive, progressive-remitting, or relapsing-remitting MS per revised McDonald Committee criteria ([McDonald et al, 2001; Polman et al, 2005] as defined by Lublin and Reingold [Lublin and Reingold 1996]; Section 22.2; Appendix B) of at least 3-month duration.
    4. EDSS 4 to 7
    5. Female subjects 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. For further details of contraceptive requirements for this study, please refer to Section 15.5.3.
    6. Subjects must be able to understand and comply with the requirements of the protocol.
    E.4Principal exclusion criteria
    1.Known allergy to pyridine-containing substances or to any of the inactive ingredients in the prolonged-release fampridine tablet.2.Any history of seizure, epilepsy, or other convulsive disorder, with the exception of febrile seizures in childhood.3. An estimated CrCl of <80 mL/minute (using the Cockcroft-Gault formula).4.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.5.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. 6.Onset of MS exacerbation within the 60 days prior to the Screening Visit, or at any time during the screening period. 7.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. 8.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.9.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)10.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)11. Uncontrolled hypertension (as determined by the Investigator) at the Screening Visit, any time during the screening period, or Day 1. 12.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). 13.Clinically significant abnormal laboratory values (as determined by the Investigator).14.A Body Mass Index ≥40.15. 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.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. 17.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.18. 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.19.Pulsed steroid treatment within the 60 days prior to the Screening Visit, or at any time during the screening period.20.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.21. 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.22.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. 23. 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.24.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 period25.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.26.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 27.Female subjects who are currently breastfeeding.28.Inability to comply with study requirements.29.Current enrollment in any other drug, biological, device, or clinical study.30.Previous participation in this study.31.Refer to Protocol
    E.5 End points
    E.5.1Primary end point(s)
    The endpoints of this study are as follows:
    1)Change from baseline in self-assessed walking disability up to Week 24 as reported on the MSWS-12.
    2)Change from baseline in balance up to Week 24 as assessed by the BBS and the TUG.
    3)Change from baseline in subjective impression of well-being (MS-related QoL) up to Week 24 as measured by the MSIS-29 physical subscale and the EuroQoL descriptive system of health-related quality of life states consisting of 5 dimensions (EQ-5D [The EuroQol Group 1990]).
    4)Subjects’ global impression of change in walking as reported on the PGIC scale.
    5)Safety of prolonged-release fampridine as assessed by the following: the number and proportion of subjects with AEs and serious AEs (SAEs) clinical laboratory parameters vital signs physical examination assessment of electrocardiograms (ECGs)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1)Screening Visit, Day 1, Weeks 2, 4, 8, 12, 16, 24 and Week 26 and Unscheduled Visit(s) 2)Screening Visit, Day 1, Weeks 2, 4, 8, 12, 16, 24 and Week 26 3)MSIS-29 = Screening Visit, Day 1, Weeks 2, 4, 8, 12, 16, and 24. EQ-5D = Day 1, Weeks 4, 8, 12, 16, 20 and 24. 4)Weeks 2, 4, 8, 12, 16, 20 and 24. 5)The number and proportion of subjects with AEs and serious AEs (SAEs) = Monitor and record throughout the study. Clinical laboratory parameters = Screening Visit, Day 1, Weeks 2, 4, 8, 12, 16, 24 and Week 26 and Unscheduled Visit(s). Vital signs = Screening Visit, Day 1, Weeks 4, 24 and Week 26 and Unscheduled Visit(s). Physical examination = Screening Visit, Day 1, Weeks 24 and Week 26 and Unscheduled Visit(s). Assessment of electrocardiograms (ECGs) = Screening Visit and Week 26
    E.5.2Secondary end point(s)
    Not Applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not Applicable
    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 Yes
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    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 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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Canada
    Italy
    Netherlands
    Sweden
    United Kingdom
    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
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 120
    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)
    No further provisions are made for access to the study 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 Decision2012-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-08-09
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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
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