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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:2017-000991-27
    Sponsor's Protocol Code Number:802NP206
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-11-30
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2017-000991-27
    A.3Full title of the trial
    A Phase 2 Placebo-Controlled, Double-Blind, Enriched Enrollment
    Randomized Withdrawal Study to Evaluate the Efficacy and Safety of BIIB074 (Vixotrigine) in Treating Pain Experienced by Subjects With Confirmed Small Fibre Neuropathy That Is Idiopathic or Associated With Diabetes Mellitus
    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 Small Fibre Neuropathy
    A.4.1Sponsor's protocol code number802NP206
    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 point802NP206 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 nameBIIB074
    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 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.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 nameBIIB074
    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.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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treating Pain Experienced by Subjects With Confirmed Small Fibre Neuropathy That is Idiopathic or
    Associated With Diabetes Mellitus
    E.1.1.1Medical condition in easily understood language
    Neurapathic pain caused by unknown reasons or by diabetes
    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 20.1
    E.1.2Level PT
    E.1.2Classification code 10073928
    E.1.2Term Small fibre neuropathy
    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 this study is to evaluate the efficacy of BIIB074 in treating pain experienced by subjects with confirmed small fibre neuropathy (SFN) that is idiopathic or associated with diabetes mellitus.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to evaluate the effect on worst pain, neuropathic pain quality, sleep interference due to pain, patient global impression, use of supplemental pain medication, and SFN symptoms in participants treated with BIIB074; to investigate the
    safety and tolerability of BIIB074 in participants with SFN; and to characterize the pharmacokinetics (PK) of BIIB074 in participants with SFN.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Corneal Confocal Microscopy (CCM) as a Screening, Predictive, and
    Surrogate Endpoint Biomarker for study 802NP206: A Phase 2 Placebo-
    Controlled, Double-Blind, Enriched Enrollment Randomized Withdrawal
    Study to Evaluate the Efficacy and Safety of BIIB074 in Treating Pain
    Experienced by Subjects With Confirmed Small Fibre Neuropathy That is
    Idiopathic or Associated With Diabetes Mellitus.

    Exploratory Objectives
    To evaluate the relationship of quantitative corneal nerve morphology
    via CCM with SFN diagnosis.
    To evaluate the relationship of quantitative corneal nerve morphology
    via CCM with initial response to BIIB074.
    To evaluate the relationship of quantitative corneal nerve morphology
    via CCM with response to continued BIIB074 treatment or placebo for 12
    weeks.
    E.3Principal inclusion criteria
    Key Inclusion Criteria:
    1. This study will be conducted in subjects who have had a diagnosis of
    at least probable SFN length-dependent distribution for ≥6 months and
    ≤10 years , based on clinical diagnosis and confirmed by intraepidermal
    nerve fibre density (IENFD) values, and
    weekly mean average daily pain (ADP) score of ≥5 and ≤9 on an 11-
    point Pain Intensity Numeric Rating Scale (PI-NRS) over the last 7 days
    of Screening.
    2. In addition to these criteria, subjects with diabetes will be required to have HbA1c ≤11%, treated with oral hypoglycemics and/or subcutaneous insulin or diet, no evidence of ulcers, advanced retinopathy (defined as greater than State 3 [moderate non-proliferative diabetic retinopathy]) (DCCT/EDIC Research Group 2017), severe nephropathy, or clinically significant obstructive atherosclerotic disease (e.g., current unstable angina or myocardial infarction within 6 months of Screening), or current class IV heart failure to be eligible for the study.
    NOTE: Other protocol defined Inclusion criteria may apply
    E.4Principal exclusion criteria
    Key Exclusion Criteria:
    1. Previous exposure to BIIB074 (formerly known as CNV1014802 or GSK1014802).
    2. Use of capsaicin patch within 3 months prior to Screening.
    3. Unable or unwilling to discontinue concomitant medications for neuropathic pain during the 2 week
    taper period, which overlaps the first week of the openlabel run-in period.
    4. Unable or unwilling to comply with the prohibited concomitant
    medication restrictions, including but not limited to UDPglucuronosyltransferase
    (UGT) inducers and inhibitors, monoamine
    oxidase inhibitors (MAOIs), and Nav blockers.
    5. Use of over-the-counter medications, vitamin and mineral
    supplements, herbal remedies (including St. John's wort), dietary
    supplements, or foods (including
    grapefruit juice) that affect UGTs.
    6. Unable or unwilling to discontinue medications that are P-glycoprotein substrates with a narrow therapeutic
    index, including but not limited to digoxin.
    7. History of hemophilia or Von Willebrand’s disease, or use of anticoagulants that may result in bleeding risk during the skin biopsy.
    8. Any contraindication, as determined by the Investigator, to performing a skin biopsy for intraepidermal nerve fibre analysis.
    9. Current hepatitis C infection (defined as positive hepatitis C virus
    [HCV] antibody and detectable HCV ribonucleic acid [RNA]). Participants
    with positive HCV antibody and undetectable HCV RNA are eligible to
    participate in the study (United States Centers for Disease Control and
    Prevention).
    NOTE: Other protocol defined Exclusion criteria may apply
    E.5 End points
    E.5.1Primary end point(s)
    1. Change from Baseline in Weekly Mean Average Daily Pain (ADP) Score:
    Participants will rate their ADP using an 11-point Numerical Rating Scale (NRS) (0=no pain and 10=worst possible pain) and record their score in an electronic diary (eDiary). Weekly mean ADP scores for Baseline (the 7 days prior to the first dose of study treatment in the open-label
    run-in period) and Week 12 (the 7 days prior to the visit at the end of Week 12) will be derived from the ADP scores and calculated as the mean of the daily scores over the last
    7 days.
    2. Change from Randomization in Weekly Mean ADP Score:
    Participants will rate their ADP using an 11-point NRS (0=no pain and 10=worst possible pain) and record their score in an eDiary. Weekly mean ADP scores for Randomization (the 7 days prior to the first dose of
    study treatment in the doubleblind
    period) and Week 12 (the 7 days prior to the visit at the end of Week 12) will be derived from the ADP scores and calculated as the mean of
    the daily scores over the last
    7 days.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Baseline and Week 12 of the Double-Blind Period
    2. Day 78 to 84 of the Double-Blind Period
    E.5.2Secondary end point(s)
    1. Change from Baseline in Weekly Mean Worst Daily Pain (WDP) Score:
    Participants will rate their WDP using
    an 11-point NRS (0=no pain and 10=worst possible pain) and record
    their score in an eDiary. Weekly mean WDP scores for Baseline (the
    7 days prior to the first dose of study
    treatment in the open-label run-in
    period) and Week 12 (the 7 days
    prior to the visit at the end of Week
    12) will be derived from the WDP
    scores and calculated as the mean
    of the daily scores over the last 7
    days.
    2. Change from Baseline in Weekly Mean Sleep Interference Numerical
    Rating Scale (S-NRS):
    Participants will rate their S-NRS using an 11-point NRS (0=pain does
    not interfere with sleep and 10= pain completely interferes with sleep) and
    record their score in an eDiary. Weekly mean S-NRS scores for Baseline (the 7 days prior to the first dose of study treatment in the openlabel run-in period) and Week 12
    (the 7 days prior to the visit at the end of Week 12) will be derived from
    the daily S-NRS scores and calculated as the mean of the daily scores over the last 7 days.
    3. Change from Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score and Sum Score:
    Participant will use the NPSI questionnaire to rate different symptoms of neuropathic pain. The NPSI includes ten items related to different pain descriptors (e.g.
    burning and pressure) that are rated
    on an 11-point NRS (0=no symptoms
    to 10=worst symptoms imaginable).
    A score in each dimension and also
    a total score (from 0-100) is generated using data from the
    questionnaire.
    4. Percentage of Participants with at least a 2-point Reduction from Baseline in Weekly Mean ADP:
    Participants will rate their ADP using
    an 11-point NRS (0=no pain and 10=worst possible pain) and record
    their score in an electronic diary
    (eDiary). Weekly mean ADP scores
    for Baseline (the 7 days prior to the
    first dose of study treatment in the
    open-label run-in period) and Week
    12 (the 7 days prior to the visit at the
    end of Week 12) will be derived from
    the ADP scores and calculated as
    the mean of the daily scores over the
    last 7 days.
    5. Percentage of Participants
    with at least a 30% Reduction from Baseline in Weekly Mean ADP:
    Participants will rate their ADP using
    an 11-point NRS) (0=no pain and
    10=worst possible pain) and record
    their score in an electronic diary
    (eDiary). Weekly mean ADP scores
    for Baseline (the 7 days prior to the
    first dose of study treatment in the
    open-label run-in period) and Week
    12 (the 7 days prior to the visit at the
    end of Week 12) will be derived from
    the ADP scores and calculated as the mean of the daily scores over the
    last 7 days.
    6. Mean Weekly Amount of Supplemental Pain Medication:
    Use of supplemental pain medication
    (paracetamol/acetaminophen) will be
    monitored and dosage will be recorded on a daily basis by the
    participant using an electronic Diary
    (eDiary). Mean weekly amount of
    supplemental pain medication used
    for neuropathic pain during the
    double-blind period.
    7. Patient Global Impression of Change (PGIC):
    PGIC is a 7-point self-administered
    scale that depicts changes in a participant's overall status. Participants will rate their change as
    “1=very much improved,” “2=much
    improved,” “3=minimally improved,”
    “4=no change,” “5=minimally worse,”
    “6=much worse,” or “7=very much
    worse.”
    8. Change from Baseline in Brief Pain Inventory-Short Form (BPI-SF) Interference Score:
    The BPI-SF is a 7-item selfadministered
    questionnaire that measures how much pain has interfered with daily functioning. Participants will rate the level of pain interference on daily functioning on an 11-point NRS where 0=does not interfere and 10=completely interferes.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Baseline and Week 12 of the Double-Blind Period
    2. Baseline and Week 12 of the Double-Blind Period
    3. Baseline and Week 12 of the Double-Blind Period
    4. Baseline and Week 12 of the Double-Blind Period
    5. Baseline and Week 12 of the Double-Blind Period
    6. Weekly from Baseline to Week 12 of the Double- Blind Period
    7. Week 12 of the Double- Blind Period
    8. Baseline and Week 12 of the Double-Blind Period
    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) 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 trial3
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA96
    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
    Canada
    Czech Republic
    Denmark
    France
    Germany
    Greece
    Hungary
    Italy
    Netherlands
    Poland
    Spain
    Switzerland
    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 years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days22
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days6
    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: 400
    F.1.3Elderly (>=65 years) No
    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 state37
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 360
    F.4.2.2In the whole clinical trial 400
    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 Decision2018-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-04-12
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