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    Summary
    EudraCT Number:2015-004796-68
    Sponsor's Protocol Code Number:1014802-204
    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:2016-09-30
    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 number2015-004796-68
    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 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
    Estudio de ampliación abierto y no controlado para evaluar la seguridad, la tolerabilidad y el mantenimiento del efecto del BIIB074 a largo plazo 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 Long Term Safety, Tolerability, and Effect of BIIB074 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
    Estudio para evaluar a largo plazo la seguridad, la tolerabilidad y el efecto del BIIB074 en sujetos con dolor neuropático por radiculopatía lumbosacra
    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 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.5.6E-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 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 INNNot available
    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 INNNot available
    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
    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 long term safety and tolerability of BIIB074 in subjects with neuropathic PLSR.
    El objetivo principal es evaluar la seguridad y la tolerabilidad a largo plazo del BIIB074 en sujetos con dolor neuropático por radiculopatía lumbosacra.
    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
    Los objetivos secundarios del estudio son:
    - Estudiar la persistencia del efecto en el tratamiento a largo plazo con BIIB074 del dolor neuropático por radiculopatía lumbosacra.
    - Evaluación del efecto del BIIB074 en la calidad de vida
    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
    los pacientes deben reunir todos los criterios enumerados a continuación en el momento del reclutamiento o en el momento indicado junto a cada criterio:
    1. Comprensión del objetivo y de los riesgos del ensayo y otorgamiento del consentimiento informado por escrito y de la autorización para el tratamiento de datos personales de salud, de conformidad con las normas vigentes en el territorio en materia de protección de datos de carácter personal.
    2. Finalización del protocolo 1014802-203 hasta la visita de la semana 14 (día 99). También podrán participar los sujetos que interrumpan el tratamiento a doble ciego pero acudan a todas las visitas del protocolo, contando hasta la visita de la semana 14 (día 99), y documenten su puntuación de dolor, salvo que haya algún problema de seguridad.
    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 Convergence Pharmaceuticals, make the subject unsuitable for enrollment.
    Criterios de exclusión:
    No podrán participar los pacientes que presenten alguno de los criterios enumerados a continuación en el momento del reclutamiento o en el momento indicado junto al criterio:
    1. Desviación mayor del protocolo relativa a los criterios de inclusión o exclusión del ensayo clínico de fase IIb y diseño doble ciego (código 1014802-203).
    2. AA o AAG relacionado con el tratamiento que suponga un aumento del riesgo si se continúa el tratamiento con BIIB074 o interrupción del tratamiento en estudio en el ensayo a doble ciego de fase IIb (código 1014802-203) por causa de un AA o AAG.
    3. No haber acudido a todas las visitas del protocolo, contando hasta la visita de la semana 14 (día 99), después de interrumpir el tratamiento en la fase a doble ciego del ensayo clínico de fase IIb.
    4. Contraindicación para la participación en el estudio 1014802-204, según se determine en la visita de la semana 14 (día 99) del estudio 1014802-203.
    5. Otras circunstancias que, a juicio del investigador o de Convergence Pharmaceuticals, contraindiquen la participación del sujeto.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints that relate to this objective are as follows:
    1. AEs and SAEs
    2. Vital signs
    3. ECG parameters
    4. Laboratory safety tests
    5. Columbia-Suicide Severity Rating Scale (C-SSRS)
    Los criterios de valoración relativos a este objetivo serán:
    1. Acontecimientos adversos y acontecimientos adversos graves.
    2. Constantes vitales.
    3. Parámetros electrocardiográficos.
    4. Análisis clínicos.
    5. Escala de Columbia para evaluar el riesgo de suicido.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1.-5. From Enrolment at all study visits (w.2, 4, 13, 26, 39, 52 and FU)
    1.-5. Desde el reclutamiento en todas las visitas del estudio (semanas 2, 4, 13, 26, 39, 52 y visita de seguimiento)
    E.5.2Secondary end point(s)
    Efficacy endpoints and timepoints in neuropathic pain:
    1. Change from Baseline to Week 52 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, where a response is defined as a > o = 50% reduction in the weekly average of the daily neuropathic pain score from Baseline to Week 52
    3. 30% neuropathic pain reduction response (yes/no) at Week 52, where a response is defined as a > o = 30% reduction in the weekly average of the daily neuropathic pain score from Baseline to Week 52
    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 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, where a responder is defined as either “much improved” or “very much improved”
    7. Change from Baseline to Week 52 on the Oswestry Disability Index
    8. Change from Baseline to Week 52 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 in the Brief Pain Inventory (BPI)-Interference index
    10. Change from Baseline (Week 2) to Week 52 in the BPI-Pain index
    11. Change from Baseline to Week 52 on the EuroQoL 5 Dimension 5-Level Questionnaire (EQ 5D-5L) health index
    12. Change from Baseline to Week 52 in the Short Form 36 Questionnaire (SF 36)
    • Criterios de valoración de la eficacia para el tratamiento del dolor neuropático:
    1. Variación entre el inicio del tratamiento y la semana 52 del promedio semanal de la puntuación diaria del dolor neuropático* en la escala numérica de 11 puntos de intensidad del dolor; 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 el día 1 del ensayo 1014802-203.
    2. Respuesta de reducción del 50% del dolor neuropático diario (sí/no) en la semana 52, entendiendo por respuesta una reducción > o = 50% del promedio semanal de la puntuación diaria de dolor neuropático entre el inicio del tratamiento y la semana 52.
    3. Respuesta de reducción del 30% del dolor neuropático diario (sí/no) en la semana 52, entendiendo por respuesta una reducción > o = 30% del promedio semanal de la puntuación diaria de dolor neuropático entre el inicio del tratamiento y la semana 52.
    4. Variación respecto al inicio del tratamiento del promedio semanal de la puntuación diaria de dolor neuropático, en todas las visitas.
    • Criterio de eficacia para el tratamiento de la lumbalgia:
    5. Variación entre el inicio del tratamiento y la semana 52 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
    Evaluación del efecto del BIIB074 en la calidad de vida:
    6. Impresión global de cambio del paciente (sí/no) en la semana 52, entendiendo que ha habido respuesta si el paciente indica «mucho mejor» o «muchísimo mejor».
    7. Variación entre el inicio del tratamiento y la semana 52 del índice de discapacidad de Oswestry.
    8. Variación entre el inicio del tratamiento y la semana 52 del promedio semanal de la puntuación diaria del sueño; todas las mañanas, los sujetos evaluarán, con la escala numérica de 11 puntos de calidad del sueño (EN-S), el insomnio provocado por el dolor en las extremidades inferiores.
    9. Variación entre el inicio del tratamiento y la semana 52 del cuestionario breve para la evaluación del dolor (BPI) en la valoración de la interferencia.
    10. Variación entre el inicio del tratamiento y la semana 52 del BPI en la valoración de la intensidad del dolor.
    11. Variación entre el inicio del tratamiento y la semana 52 del índice de salud del cuestionario EuroQoL de 5 dimensiones y 5 niveles.
    12. Variación entre el inicio del tratamiento y la semana 52 del cuestionario breve SF-36.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For timepoints of secondary endpoints please refer to E.5.2.
    Para los tiempos de los criterios de valoración secundarios refiérase al punto 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
    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 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 concerned8
    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
    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
    Última Visita del último paciente
    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 months1
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days16
    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 state80
    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
    Tratamiento habitual
    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 Decision2016-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-02-08
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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