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    Summary
    EudraCT Number:2015-004796-68
    Sponsor's Protocol Code Number:1014802-204
    National Competent Authority:Czech Republic - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-10-13
    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 ConcernedCzech Republic - SUKL
    A.2EudraCT number2015-004796-68
    A.3Full title of the trial
    An Uncontrolled, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Maintenance of Effect of BIIB074 (Vixotrigine) in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
    Odslepené, bez kontrolní skupiny pokračující klinické hodnocení dlouhodobé bezpečnosti,snášenlivosti a udržení účinku přípravku BIIB074 (Vixotriginu)u subjektů s neuropatickou bolestí způsobenou lumbosakrální radikulopatií.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate the Long Term Safety, Tolerability, and Effect of BIIB074 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
    A.4.1Sponsor's protocol code number1014802-204
    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 pointN/A
    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@biogen.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 No
    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 nameVixotrigine
    D.3.2Product code BIIB074
    D.3.4Pharmaceutical form Coated 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 INNVixotrigine
    D.3.9.1CAS number 934240-31-0
    D.3.9.2Current sponsor codeBIIB074
    D.3.9.3Other descriptive nameCNV1014802A
    D.3.9.4EV Substance CodeSUB32074
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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.IMP: 2
    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 No
    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 nameVixotrigine
    D.3.2Product code BIIB074
    D.3.4Pharmaceutical form Coated 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 INNVixotrigine
    D.3.9.1CAS number 934240-31-0
    D.3.9.2Current sponsor codeBIIB074
    D.3.9.3Other descriptive nameCNV1014802A
    D.3.9.4EV Substance CodeSUB32074
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Neuropathic Pain
    From Lumbosacral Radiculopathy
    E.1.1.1Medical condition in easily understood language
    Neuropathic Pain
    From Lumbosacral Radiculopathy
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10054095
    E.1.2Term Neuropathic pain
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10050219
    E.1.2Term Lumbar radiculopathy
    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 the study is to evaluate the long term safety and tolerability of BIIB074 in subjects with neuropathic PLSR.
    E.2.2Secondary objectives of the trial
    Secondary objectives of the study are:
    - To investigate the maintenance of effect during long-term treatment with BIIB074 in subjects with neuropathic PLSR
    -To evaluate the impact of treatment with BIIB074 on quality of life
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The candidates must meet the following eligibility criteria at enrollment, or at the timepoint specified in the individual eligibility criterion listed:
    1.Is able to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations.
    2.Has completed Study 1014802-203 through the Week 14 (Day 99) visit. Subjects who discontinued double-blind study treatment but continued to return for study visits through Week 14 (Day 99) and document their pain scores are eligible unless there are safety concerns
    E.4Principal exclusion criteria
    Exclusion Criteria:
    Candidates will be excluded from study entry if any of the following exclusion criteria exist at enrollment, or at the timepoint specified in the individual criterion listed:
    1. Had a major protocol deviation regarding inclusion or exclusion criteria for the double--blind Phase 2b study (Study 1014802-203).
    2. Had a treatment-related AE or SAE that would pose an increased risk for continued treatment with BIIB074, or discontinued study treatment in the double-blind Phase 2b study (Study 1014802-203) due to an AE or SAE.
    3. Did not return for study visits through Week 14 (Day 99) after discontinuing treatment in the double-blind phase of the Phase 2b study.
    4. Is unable to enroll in the 1014802-204 Study on the 1014802-203 Week 14 (Day 99) visit.
    5. Other unspecified reasons that, in the opinion of the Investigator or Biogen, make the subject unsuitable for enrollment.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint that relates to this objective is the incidence of
    AEs and SAEs during the 12-month open label period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Enrolment at all study visits (w.2, 4, 13, 26, 39, 52 and FU)
    E.5.2Secondary end point(s)
    Efficacy endpoints and timepoints in neuropathic pain:
    1. Change from Baseline to Week 52 and Week 104 in the weekly average of the daily neuropathic pain* score on the 11 point Pain Intensity Numerical Rating Scale (PI NRS); subjects will be asked every evening to rate their overall neuropathic pain for the last 24 hour period
    *Neuropathic pain will be evaluated in the worse affected leg, as identified on Day 1 of Study 1014802-203.
    2. 50% neuropathic pain reduction response (yes/no) at Week 52 and Week 104 , where a response is defined as a ≥50% reduction in the weekly average of the daily neuropathic pain score from Baseline to Week 52 and Week 104
    3. 30% neuropathic pain reduction response (yes/no) at Week 52 and Week 104 , where a response is defined as a ≥30% reduction in the weekly average of the daily neuropathic pain score from Baseline to Week 52 and Week 104
    4. Changes from Baseline in the weekly average of the daily neuropathic pain score at each visit
    •Efficacy endpoint in low back pain:
    5. Change from Baseline to Week 52 and Week 104 in the weekly average of the daily pain score for low back pain; subjects will be asked every evening to rate their overall low back pain for the last 24-hour period.
    The endpoints that relate to the impact of treatment with BIIB074 on quality of life are as follows:
    6. Patient Global Impression of Change (PGIC) responder (yes/no) at Week 52 and Week 104 , where a responder is defined as either “much improved” or “very much improved”
    7. Change from Baseline to Week 52 and Week 104 on the Oswestry Disability Index
    8. Change from Baseline to Week 52 and Week 104 in the weekly average of the daily sleep score; subjects will be asked every morning to rate on the 11-point Sleep Numerical Rating Scale (S-NRS) how leg pain interfered with their sleep quality
    9. Change from Baseline to Week 52 and Week 104 in the Brief Pain Inventory (BPI)-Interference index
    10. Change from Baseline (Week 2) to Week 52 and Week 104 in the BPI-Pain index
    11. Change from Baseline to Week 52 and Week 104 on the EuroQoL 5 Dimension 5-Level Questionnaire (EQ 5D-5L) health index
    12. Change from Baseline to Week 52 and Week 104 in the Short Form 36 Questionnaire (SF 36)
    E.5.2.1Timepoint(s) of evaluation of this end point
    For timepoints of secondary endpoints please refer to E.5.2.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA64
    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
    Austria
    Belgium
    Bulgaria
    Czech Republic
    Estonia
    Finland
    France
    Georgia
    Italy
    Latvia
    Lithuania
    Netherlands
    Romania
    Serbia
    Slovakia
    Spain
    United Kingdom
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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: 323
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 347
    F.4.2.2In the whole clinical trial 403
    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)
    Standard of care
    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 Decision2016-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-02-08
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