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    The EU Clinical Trials Register currently displays   41189   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2016-001449-16
    Sponsor's Protocol Code Number:802NP301
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-03-21
    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 ConcernedFinland - Fimea
    A.2EudraCT number2016-001449-16
    A.3Full title of the trial
    A Phase 3 Placebo-Controlled, Double-Blind Randomized Withdrawal Study to Evaluate the Efficacy and Safety of BIIB074 (Vixotrigine) in Subjects With Trigeminal Neuralgia
    Vaiheen 3 lumelääkekontrolloitu, kaksoissokkoutettu, hoidon lopetuksen suhteen satunnaistettu tutkimus, jossa arvioidaan BIIB074-valmisteen (viksotrigiinin) tehoa ja turvallisuutta tutkittavilla, joilla on kolmoishermosärkyä
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of BIIB074 in Participants with Trigeminal Neuralgia
    Vaiheen 3 lumelääkekontrolloitu, kaksoissokkoutettu, hoidon lopetuksen suhteen satunnaistettu tutkimus, jossa arvioidaan BIIB074-valmisteen (viksotrigiinin) tehoa ja turvallisuutta tutkittavilla, joilla on kolmoishermosärkyä
    A.3.2Name or abbreviated title of the trial where available
    SURGE
    A.4.1Sponsor's protocol code number802NP301
    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 point802NP301 Clinical Trial Team
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House, 70 Norden Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    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 Film-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 nameCNV1014802
    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 Film-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 nameCNV1014802
    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 number250
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated 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
    Trigeminal Neuralgia
    E.1.1.1Medical condition in easily understood language
    Trigeminal Nerve Disorder
    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 PT
    E.1.2Classification code 10044652
    E.1.2Term Trigeminal neuralgia
    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 efficacy of BIIB074 in treating pain experienced by subjects with TN.

    The primary objective of the LTE phase of the study is to evaluate the long-term safety and tolerability of BIIB074 in subjects with TN.
    E.2.2Secondary objectives of the trial
    Secondary objectives include the following:
    - To investigate the safety and tolerability of BIIB074 in subjects with TN.
    - To evaluate the population PK of BIIB074.

    The secondary objective of the LTE is to investigate the maintenance of effect during long-term treatment with BIIB074 in subjects with TN.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - A diagnosis of TN for at least 3 months based on IHS diagnostic criteria.
    - Participant must have failed at least 1 prior standard of care pharmacologic treatment for TN (defined as an inadequate response or intolerance to treatment), as determined by the Investigator based on medical history.
    - Age ≥18 years at the time of informed consent.
    - Allowed concomitant medications must have been stable for at least 4 weeks prior to Day 1 of the dose-optimization period. The maximum dosage of
    carbamazepine allowed on Day 1 is 400 mg/day (or 600 mg/day for oxcarbazepine).
    - Participants must have recorded their pain score in their eDiary on at least 5 days during the run-in period (Days -7 to -1).
    NOTE: Other protocol defined Inclusion criteria may apply
    E.4Principal exclusion criteria
    - History or positive test result at Screening for hepatitis C virus antibody or current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody [HBcAb]).
    - Positive history of human immunodeficiency virus (HIV) or a positive HIV test at Screening.
    - Participants with facial pain other than TN.
    - Personal or family (first-degree relative) history of seizures (except for simple febrile convulsions) or clinically significant head injury.
    -Known hypersensitivity to BIIB074 or components of the BIIB074 formulation or matching placebo.
    -Positive pregnancy test result at Screening (women of childbearing potential only)
    -Has donated blood or blood products within a 30-day period prior to Screening.
    NOTE: Other protocol defined Exclusion criteria may apply
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of subjects classified as responders at Week 12 of the double-blind period.
    A participant who meets all of the following criteria will be classified as a
    responder:
    (1)Has a reduction of >=30% in mean pain score compared with baseline
    (2)Has not discontinued randomized treatment before the end of Week 12 of the double-blind period
    (3)Has not taken prohibited pain medication before the end of Week 12 of the double-blind period.

    The primary endpoint of LTE phase is the number of participants experiencing AEs and SAEs during the LTE from Baseline up to Week 104.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint is the proportion of subjects classified as responders at Week 12 of the double-blind period.

    The primary endpoint of LTE phase is the number of participants experiencing AEs and SAEs during the LTE from Baseline up to Week 104.
    E.5.2Secondary end point(s)
    The endpoints that relate to this objective are AUC and Cmax at steady state.

    The secondary endpoints of LTE phase include the following:
    - Proportion of subjects with a response based on a ≥30% reduction in mean pain score during 4-week periods beginning on Day 1 through Week 104 of the LTE compared with baseline (run-in)
    - Change from baseline in mean pain score during 4-week periods beginning on Day 1 through Week 104 of the LTE
    - Change from baseline in mean worst pain score during 4-week periods beginning on Day 1 through Week 104 of the LTE
    - Proportion of subjects with a response based on a ≥50% reduction in mean number of paroxysms during 4-week periods beginning on Day 1 through Week 104 of the LTE compared with baseline (run-in)
    - Change from baseline in mean number of paroxysms during 4-week periods beginning on Day 1 through Week 104 of the LTE
    - Proportion of subjects with a PGIC response of “much improved” or “very much
    improved” by visit during the LTE
    - Change from baseline in the PENN-FPS-R score by visit during the LTE
    - Change from baseline in the EQ-5D-5L score by visit during the LTE
    - Change from baseline in the WPAI: Neuropathic Pain (V2.0) score by visit during the LTE
    E.5.2.1Timepoint(s) of evaluation of this end point
    The endpoints that relate to this objective are AUC and Cmax at steady state.

    The secondary endpoints of LTE phase include the following:
    - Proportion of subjects with a response based on a ≥30% reduction in mean pain score during 4-week periods beginning on Day 1 through Week 104 compared with baseline (run-in)
    - Change from baseline in mean number of paroxysms during 4-week periods beginning on Day 1 through Week 104
    - Proportion of subjects with a PGIC response of “much improved” or “very much
    improved” by visit
    - Change from baseline in the PENN-FPS-R score by visit
    - Change from baseline in the EQ-5D-5L score by visit
    - Change from baseline in the WPAI: Neuropathic Pain (V2.0) score by visit
    NOTE: Other protocol defined timepoints may apply
    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 Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA61
    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
    Argentina
    Austria
    Belgium
    Bulgaria
    Canada
    Denmark
    Estonia
    Finland
    Germany
    Japan
    Korea, Republic of
    Russian Federation
    Serbia
    Slovakia
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 250
    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)
    None
    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 Decision2017-04-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusOngoing
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