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    Summary
    EudraCT Number:2015-004775-78
    Sponsor's Protocol Code Number:1014802-203
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-05-11
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2015-004775-78
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of BIIB074 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
    Estudio aleatorizado, doble ciego, controlado con un placebo y en grupos paralelos para evaluar la eficacia y la seguridad del BIIB074 en sujetos con dolor neuropático por radiculopatía lumbosacra
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate the Efficacy and Safety of BIIB074 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
    Estudio para evaluar la Eficacia y Seguridad del BIIB074 en sujetos con dolor neuropático por radiculopatía lumbosacra
    A.4.1Sponsor's protocol code number1014802-203
    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 SponsorConvergence Pharmaceuticals Ltd
    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 supportConvergence Pharmaceuticals Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationConvergence Pharmaceuticals Ltd
    B.5.2Functional name of contact pointN/A
    B.5.3 Address:
    B.5.3.1Street AddressMaia Building, Babraham Research Campus
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB22 3AT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+34911459110
    B.5.6E-mailregulatory.spain@pharm-olam.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 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 INNRaxatrigine (proposed)
    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 nameBIIB074
    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 INNRaxatrigine (proposed)
    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
    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
    Neuropathic Pain From Lumbosacral Radiculopathy
    Dolor neuropático por radiculopatía lumbosacra
    E.1.1.1Medical condition in easily understood language
    Neuropathic Pain From Lumbosacral Radiculopathy
    Dolor neuropático por radiculopatía lumbosacra
    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 19.0
    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 19.0
    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 efficacy of 2 dose regimens of BIIB074 on neuropathic pain in subjects with PLSR.
    El objetivo principal del ensayo es evaluar la eficacia de dos pautas posológicas de BIIB074 para el tratamiento del dolor neuropático en sujetos con DRLS.
    E.2.2Secondary objectives of the trial
    A secondary objective is to evaluate the efficacy of 2 dose regimens of BIIB074 on additional neuropathic pain measures and assessments of low back pain, disability, and quality of life.
    Uno de los objetivos secundarios es evaluar la eficacia de dos pautas posológicas de BIIB074 en otras medidas del dolor neuropático y en la evaluación de la lumbalgia, la discapacidad y la calidad de vida.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key Inclusion Criteria:
    - Men and women aged 18 to 75 years inclusive
    - Has body weight > o =50 kg for men and > o = 45 kg for women
    - Must have diagnosis of neuropathic PLSR
    - Has duration of neuropathic (leg) pain of at least 6 months before Screening

    Other protocol-defined inclusion/exclusion criteria may apply.
    Criterios clave de Inclusión:
    - Hombres y mujeres con edad comprendida entre los 18 y los 75 años inclusive
    - Peso corporal > o = 50 kg en el caso de los varones y > o = 45 kg en el caso de las mujeres
    - Diagnóstico de dolor neuropático por radiculopatía lumbosacra (DRLS)
    - Tiempo de evolución del dolor neuropático (en la extremidad inferior) > o = 6 meses en el momento de la selección.
    E.4Principal exclusion criteria
    Key Exclusion Criteria:
    - Has planned surgical intervention for PLSR within the duration of the study.
    - Has a history of peripheral neuropathy (e.g., due to diabetes, alcohol consumption, other causes, or idiopathic) or evidence of peripheral neuropathy upon neurological examination
    - Has a history or risk of seizures or a history of epilepsy, clinically significant head injury, or related neurological disorders

    Other protocol-defined inclusion/exclusion criteria may apply.
    Criterios clave de exlusión:
    - Intervención quirúrgica para el DRLS programada dentro del período del ensayo clínico
    - Antecedentes de neuropatías periféricas (p. ej., por diabetes, consumo de alcohol, otras causas o idiopática) o signos de neuropatía periférica en la exploración neurológica.
    - Antecedentes o riesgo de convulsiones y antecedentes de epilepsia, de traumatismos craneales de relevancia clínica o de trastornos neurológicos relacionados.

    Se pueden aplicar otros criterios de inclusión / exclusión definidos en el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint that relates to this objective is the change from Baseline (Week 2) to Week 14 in the weekly average of the daily neuropathic pain* score on the 11-point 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 at Screening.
    El criterio de valoración relativo a ese objetivo es la variación entre el inicio del tratamiento (semana 2) y la semana 14 del promedio semanal de la puntuación diaria del dolor neuropático* de la escala numérica de 11 puntos de intensidad del dolor (EN-D).
    Los sujetos deberán evaluar el dolor neuropático todas las noches, haciendo referencia a las últimas 24 horas.
    *Se evaluará el dolor neuropático de la extremidad inferior más afectada, que se determinará en la selección.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 14 last 24-hour period.
    Semana 14 último periodo de 24 horas.
    E.5.2Secondary end point(s)
    Efficacy endpoints in neuropathic pain:
    1. 50% neuropathic daily pain reduction response (yes/no) at Week 14, where a response is defined as a ?50% reduction in the weekly average of the daily neuropathic pain score from Baseline (Week 2) to Week 14
    2. 30% neuropathic daily pain reduction response (yes/no) at Week 14, where a response is defined as a ?30% reduction in the weekly average of the daily neuropathic pain score from Baseline (Week 2) to Week 14?
    3. Changes from Baseline (Week 2) in the weekly average of the daily neuropathic pain score at each visit
    Efficacy endpoint in low back pain:
    4. Change from Baseline (Week 2) to Week 14 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 Other efficacy endpoints:
    5. Patient Global Impression of Change (PGIC) responder (yes/no) at Week 14, where a responder is defined as either ?much improved? or ?very much improved?
    6. Change from Baseline (Week 2) to Week 14 on the Oswestry Disability Index
    7. Change from Baseline (Week 2) to Week 14 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
    8.Change from Baseline (Week 2) to Week 14 in the Brief Pain Inventory (BPI)- Interference index
    9. Change from Baseline (Week 2) to Week 14 in the BPI-Pain index
    10. Change from Baseline (Week 2) to Week 14 on the EuroQoL 5-Dimension
    5-Level Questionnaire (EQ-5D-5L) health index
    11. Change from Baseline (Week 2) to Week 14 in the Short Form 36 Questionnaire (SF-36)
    12. Amount of rescue medication used (dosage/day)
    Another secondary objective is to investigate the safety and tolerability of 2 dose regimens of BIIB074.
    The endpoints that relate to this objective are as follows:
    ? AEs and SAEs
    ? Vital signs
    ? ECG parameters
    ? Laboratory safety tests
    ? Columbia-Suicide Severity Rating Scale (C-SSRS)
    Another secondary objective is to characterize the PK of BIIB074 in this population.
    Criterios de valoración de la eficacia para el tratamiento del dolor neuropático:
    1. Respuesta de reducción del 50% del dolor neuropático diario (sí/no) en la semana 14, entendiendo por respuesta una reducción ?50% del promedio semanal de la puntuación diaria de dolor neuropático entre el inicio del tratamiento (semana 2) y la semana 14.
    2. Respuesta de reducción del 30% del dolor neuropático diario (sí/no) en la semana 14, entendiendo por respuesta una reducción ?30% del promedio semanal de la puntuación diaria de dolor neuropático entre el inicio del tratamiento (semana 2) y la semana 14.
    3. Variación respecto al inicio del tratamiento (semana 2) del promedio semanal de la puntuación diaria del dolor neuropático, en todas las visitas.
    Criterio de eficacia para el tratamiento de la lumbalgia:
    4. Variación entre el inicio del tratamiento (semana 2) y la semana 14 del promedio semanal de la puntuación diaria de la lumbalgia; los sujetos tendrán que evaluar el grado de lumbalgia general todas las noches, haciendo referencia a las últimas 24 horas.
    Otros criterios de valoración de la eficacia serán:
    5. Impresión global de cambio del paciente (sí/no) en la semana 14, entendiendo que ha habido respuesta si el paciente indica «mucho mejor» o «muchísimo mejor».
    6. Variación entre el inicio del tratamiento (semana 2) y la semana 14 del índice de discapacidad de Oswestry.
    7. Variación entre el inicio del tratamiento (semana 2) y la semana 14 del promedio semanal de la puntuación diaria del sueño; todas las mañanas, los sujetos evaluarán, con una escala numérica de 11 puntos, la afectación de la calidad del sueño provocada por el dolor en las extremidades inferiores.
    8. Variación entre el inicio del tratamiento (semana 2) y la semana 14 del cuestionario breve para la evaluación del dolor (BPI) en la valoración de la interferencia.
    9. Variación entre el inicio del tratamiento (semana 2) y la semana 14 del BPI en la valoración de la intensidad del dolor.
    10. Variación entre el inicio del tratamiento (semana 2) y la semana 14 del índice de salud del cuestionario EuroQoL de 5 dimensiones y 5 niveles.
    11. Variación entre el inicio del tratamiento (semana 2) y la semana 14 del cuestionario breve SF-36.
    12. Cantidad de medicación de rescate empleada (dosis por día).
    Estudiar la seguridad y la tolerabilidad de dos pautas posológicas de BIIB074:
    Acontecimientos adversos y acontecimientos adversos graves.
    Constantes vitales.
    Parámetros electrocardiográficos.
    Análisis clínicos.
    Escala de Columbia evaluar el riesgo de suicido.
    Otro objetivo secundario es describir la farmacocinética (FC) del BIIB074 en esta población de pacientes.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Points 1; 2; 6 - Week 14
    Point 3 - Changes from Baseline (Week 2) in the weekly average of the daily neuropathic pain score at each visit.
    Point 4-11 -Change from Baseline (Week 2) to Week 14
    Puntos 1; 2;6 - Semana 14
    Punto 3 - Variación respecto al inicio del tratamiento (semana 2) del promedio semanal de la puntuación diaria del dolor neuropático, en todas las visitas.
    Punto 4-11 - Variación entre el inicio del tratamiento (semana 2) y la semana 14
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerabilidad
    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 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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    France
    Georgia
    Italy
    Latvia
    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
    Última Visita del último paciente
    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 days3
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days3
    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) Yes
    F.1.3.1Number of subjects for this age range: 104
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 434
    F.4.2.2In the whole clinical trial 504
    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)
    Eligible subjects may continue into the extension study, Study 1014802-204.
    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 Decision2016-07-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-08-06
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