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    Summary
    EudraCT Number:2013-003600-40
    Sponsor's Protocol Code Number:218MS305
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-07-21
    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 ConcernedFinland - Fimea
    A.2EudraCT number2013-003600-40
    A.3Full title of the trial
    A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects with Multiple Sclerosis (ENHANCE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects with Multiple Sclerosis (ENHANCE)
    A.4.1Sponsor's protocol code number218MS305
    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-mailclinicaltrials@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 17.1
    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 primary objective of Study 218MS305 is to determine whether prolonged-release fampridine (10 mg BID) has a clinically meaningful effect on patient-reported walking ability over a 24-week study period.
    E.2.2Secondary objectives of the trial
    The secondary objectives are as follows:
    o To determine whether prolonged-release fampridine 10 mg BID has a clinically meaningful effect on dynamic and static balance, physical impact of MS, and upper extremity function over a 24-week study period
    o To evaluate criteria for early assessment of response to fampridine that can predict clinically meaningful benefits in walking ability and balance
    o To assess the safety and tolerability of prolonged-release fampridine 10 mg BID over a 24-week treatment period.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    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. Aged 18 to 70 years, inclusive, at the time of informed consent.
    3. Female subjects of childbearing potential must have a negative urine pregnancy test at the Screening Visit and on Day 1. All subjects must agree to 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 effective contraception methods, see Section 15.5.3.
    4. Must have a diagnosis of primary-progressive, secondary-progressive, progressive-relapsing, or relapsing-remitting MS per revised McDonald Committee criteria [McDonald 2001; Polman 2005] as defined by Lublin and Reingold [Lublin and Reingold 1996] of at least 3 months duration.
    5. Must have an EDSS score of 4 to 7, inclusive.
    6. Must have walking impairment, as deemed by the Investigator.
    7. Subjects must be able to understand and comply with the requirements of the protocol.
    E.4Principal exclusion criteria
    1. History of human immunodeficiency virus (HIV).
    2. Presence of acute or chronic hepatitis. Subjects who have evidence of prior hepatitis infection that has been serologically confirmed as resolved are not excluded from study participation.
    3. Known allergy to fampridine, pyridine-containing substances or any of the inactive ingredients in the prolonged-release fampridine tablet.
    4. Any history of seizure, epilepsy or other convulsive disorder, with the exception of febrile seizures in childhood.
    5. CrCl of <80 mL/min.
    6. 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.
    7. Onset of MS exacerbation within 60 days prior to the Screening Visit, or at any time during the screening period.
    8. History of any major surgical intervention (with the exception of skin biopsy) within the 30 days prior to the Screening Visit or Day 1 or at any time during the screening period.
    9. 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.
    10. Presence of pulmonary disease including, but not limited to, chronic obstructive pulmonary disease that can impede the subject’s daily activities (as determined by the Investigator).
    11. 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).
    12. Uncontrolled hypertension (as determined by the Investigator) at the Screening Visit or at any time during the screening period.
    13. History of any clinically significant cardiac, 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).
    14. Clinically significant abnormal laboratory values.
    15. A body mass index (BMI) ≥40 (BMI formula: BMI=mass [kg]/[height(m)]2)
    16. History of severe allergic or anaphylactic reactions.
    17. Use of off-label MS treatment including rituximab, daclizumab or antibody (except natalizumab) within 3 months prior to the Screening Visit, at any time during the screening period or scheduled for use during study participation.
    18. Use of mitoxantrone or cyclophosphamide within 3 months prior to the Screening Visit, at any time during the screening period or scheduled for use during study participation.
    19. Initiation of natalizumab or alemtuzumab treatment or any change in the subject’s dose or regimen of natalizumab or alemtuzumab, within 3 months prior to the Screening Visit or at any time during the screening period.
    20. Initiation of treatment with, or any change in the subject’s dose or regimen of, interferon β-1b, interferon β-1a, fingolimod, teriflunomide, glatiramer acetate or dimethyl fumarate within the 30 days prior to the Screening Visit or at any time during the screening period.
    21. Pulsed steroid treatment within the 60 days prior to the Screening Visit or at any time during the screening period.
    22. 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.
    23. 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.
    24. Any change in the subject’s dose or regimen of antispastic agents within 7 days prior to the Screening Visit or at any time during the screening period.
    25. Treatment with an investigational drug within the 30 days (or 7 half-lives, whichever is longer) prior to the Screening Visit or at any time during the screening period.
    26. Treatment with any aminopyridine (fampridine, 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.
    27. Treatment with organic cation transporter 2 (OCT2) inhibitors within 5 half-lives prior to the Screening Visit or at any time during the screening period
    28. History of drug or alcohol abuse within the 2 years prior to the Screening Visit.
    29. Female subjects who are currently pregnant or who are considering becoming pregnant while participating in the study.
    30. Female subjects who are currently breastfeeding.
    31. Inability to comply with study requirements.
    32. Subject who plan to participate in another clinical study (including any observational studies) during the course of the current study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the proportion of subjects who achieve a mean improvement on the MSWS-12 of ≥8-points from baseline over a 24-week treatment period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Screening, Day 1, Week 2, Weeks 4, 8, 12, 16, 20 and 24/early termination and during follow up.
    E.5.2Secondary end point(s)
    Proportion of subjects who achieve a mean improvement in TUG speed of ≥15% from baseline over a 24-week period
    Change from baseline over a 24-week treatment period in the following
    o MSIS-29 physical score
    o BBS
    o ABILHAND
    E.5.2.1Timepoint(s) of evaluation of this end point
    Proportion of subjects who achieve a mean improvement in TUG speed of ≥15% from baseline over a 24-week period = Screening, Day 1, Week 2, Weeks 4, 8, 12, 16, 20 and 24/early termination and during follow up.
    Change from baseline over a 24-week treatment period in the following
    o MSIS-29 physical score = Screening, Day 1, Week 2, Weeks 4, 8, 12, 16, 20 and 24/early termination
    o BBS = Screening, Day 1, Week 2, Weeks 12 and 24/early termination
    o ABILHAND = Day 1, Week 2, Weeks 8 and 20
    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 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) Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA74
    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
    Bulgaria
    Czech Republic
    Finland
    Italy
    Lithuania
    Netherlands
    Poland
    Russian Federation
    Serbia
    Switzerland
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 study is last subject, last visit for final collection of data for the primary outcome.
    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 months4
    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 months8
    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: 560
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 386
    F.4.2.2In the whole clinical trial 590
    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 under this protocol.
    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 Decision2014-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-08-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-02-11
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