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    Summary
    EudraCT Number:2017-000991-27
    Sponsor's Protocol Code Number:802NP206
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-12-01
    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 ConcernedSpain - AEMPS
    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 in Treating Pain Experienced by Subjects With Confirmed Small Fibre Neuropathy That is Idiopathic or Associated With Diabetes Mellitus
    Estudio de retirada aleatorizado en fase II, controlado con placebo y doble ciego con reclutamiento enriquecido para evaluar la eficacia y la seguridad de BIIB074 en el tratamiento del dolor sufrido por sujetos con neuropatía de fibras pequeñas confirmada e idiopática o asociada a 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
    Eficacia y seguridad de BIIB074 en sujetos con neuropatía de fibras pequeñas
    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.5.4Telephone number+34913107110
    B.5.5Fax number+34913107181
    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 INNN/A
    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 INNN/A
    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
    Ttratamiento del dolor sufrido por sujetos con Neuropatía de Fibras Pequeñas confirmada que es idiopática o está asociada a diabetes mellitus.
    E.1.1.1Medical condition in easily understood language
    Neurapathic pain caused by unknown reasons or by diabetes
    Dolor neuropático causado por razones desconocidas o por 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.
    El objetivo principal de este estudio es evaluar la eficacia de BIIB074 en el
    tratamiento del dolor sufrido por sujetos con Neuropatía de Fibras Pequeñas (NFP) confirmada que es idiopática o está asociada a 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.
    Los objetivos secundatios de este estudio son evaluar el efecto en el peor dolor, la calidad del dolor neuropático, la interferencia en el sueño debida al dolor, la impresión global del paciente, el empleo de analgésicos complementarios y los síntomas de la NFP en los sujetos tratados con BIIB074; Investigar la seguridad y la tolerabilidad de BIIB074 en los sujetos con NFP. 3; y caracterizar la farmacocinética (FC) de BIIB074 en sujetos con NFP.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key Inclusion Criteria:
    1. This study will be conducted in subjects who have had a diagnosis of at least possible SFN for 6 months or
    more, 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 obstructive atherosclerotic disease resulting from their diabetes to be eligible for the
    study.
    NOTE: Other protocol defined Inclusion criteria may apply
    Criterios de inclusión principales:
    1. Este estudio se llevará a cabo en sujetos que cuenten con un diagnóstico de posible neuropatía de fibras pequeñas (NFP) desde hace al menos 6 meses o más, de acuerdo con un diagnóstico clínico y confirmado mediante los valores de la densidad de las fibras nerviosas intraepidérmicas (DFNIE) y una puntuación media semanal del dolor promedio diario (DPD) de #5 y #9 en la escala numérica de 11 puntos sobre la intensidad del dolor (EN-ID) durante los últimos 7 días a partir de la selección.
    2. Además de estos criterios, para ser aptos para el estudio, los sujetos con diabetes deberán presentar HbA1c #11 %, tratada con hipoglucémicos por vía oral, insulina por vía subcutánea o dieta; no presentar indicios de úlceras; presentar retinopatía avanzada (definida como superior al estado 3 [retinopatía diabética no proliferativa moderada]) (DCCT/EDIC Research Group 2017), nefropatía grave o ateroesclerosis obstructiva derivada de la diabetes.
    NOTA: Podrán aplicarse otros criterios de inclusión definidos en el protocolo
    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 CYP3A4 and UDP-glucuronosyltransferase (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 CYP3A and 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.
    NOTE: Other protocol defined Inclusion criteria may apply
    Criterios de exclusión principales:
    1. Exposición previa a BIIB074 (anteriormente denominado CNV1014802 o GSK1014802). 2. Uso de parches de capsaicina durante los 3 meses previos a la selección. 3. El sujeto no puede o no desea interrumpir el uso de la medicación concomitante para el dolor neuropático durante las dos semanas del periodo de disminución progresiva de la dosis, que se superpone con la primera semana del periodo de preinclusión abierto. 4. El sujeto no puede o no desea cumplir las restricciones respecto a la medicación concomitante prohibida, que incluye, entre otros, inductores e inhibidores de CYP3A4 y UDP-glucuronosiltransferasa (UGT), inhibidores de la monoaminoxidasa (IMAO) y bloqueadores de canales de sodio (Nav). 5. Uso de medicamentos de venta sin receta, los complementos de vitaminas y minerales, remedios a base de plantas medicinales (incluida la hierba de San Juan), los complementos alimenticios o ciertos alimentos (como el zumo de pomelo) que afecten a las enzimas CYP3A y UGT. 6. El sujeto no puede o no desea interrumpir el uso de medicamentos que son sustratos de la glucoproteína-P con un índice terapéutico estrecho, como, entre otros, la digoxina. 7. Antecedentes de hemofilia o enfermedad de Von Willebrand o bien, uso de anticoagulantes que pueden provocar riesgos de hemorragia durante la biopsia cutánea. 8. Cualquier contraindicación, según determine el investigador, para llevar a cabo una biopsia cutánea para el análisis de las fibras nerviosas intraepidérmicas. NOTA: Podrán aplicarse otros criterios de inclusión definidos en el protocolo
    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.
    1. Cambio respecto al inicio en la puntuación media semanal del dolor promedio diario (DPD): Los participantes evaluarán su DPD mediante una escala numérica (EN) de 11 puntos (0 = ausencia de dolor y 10 = peor dolor posible) y registrarán su puntuación en un diario electrónico. Las puntuaciones medias semanales del DPD para el inicio (7 días antes de la primera dosis del tratamiento del estudio en el periodo de preinclusión abierto) y para la semana 12 (7 días antes de la visita al final de la semana 12) se derivarán de las puntuaciones del DPD y se calcularán como el valor medio de las puntuaciones diarias de los últimos 7 días. 2. Cambio desde la aleatorización en la puntuación media semanal del DPD: Los participantes evaluarán su DPD mediante una EN de 11 puntos (0 = ausencia de dolor y 10 = peor dolor posible) y registrarán su puntuación en un diario electrónico. Las puntuaciones medias semanales del DPD para la aleatorización (7 días antes de la primera dosis del tratamiento del estudio en el periodo doble ciego) y para la semana 12 (7 días antes de la visita al final de la semana 12) se derivarán de las puntuaciones del DPD y se calcularán como el valor medio de las puntuaciones diarias de los últimos 7 días.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Baseline and Week 12 of the Double-Blind Period
    2. Randomization and Week 12 of the Double-Blind Period
    1. Inicio y semana 12 del periodo doble ciego
    2. Aleatorización y semana 12 del periodo doble ciego
    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.
    1. Cambio respecto al inicio en la puntuación media semanal del peor dolor diario (PDD): Los participantes evaluarán su PDD mediante una EN de 11 puntos (0 = ausencia de dolor y 10 = peor dolor posible) y registrarán su puntuación en un diario electrónico. Las puntuaciones medias semanales del PDD para el inicio (7 días antes de la primera dosis del tratamiento del estudio en el periodo de preinclusión abierto) y para la semana 12 (7 días antes de la visita al final de la semana 12) se derivarán de las puntuaciones del PDD y se calcularán como el valor medio de las puntuaciones diarias de los últimos 7 días. 2. Cambio con respecto al inicio en la escala numérica sobre la interferencia con el sueño media semanal (EN-S): Los participantes evaluarán su EN-S mediante una EN de 11 puntos (0 = ausencia de interferencia con el sueño y 10 = el dolor interfiere totalmente con el sueño) y registrarán su puntuación en un diario electrónico. Las puntuaciones medias semanales de la EN-S para el inicio (7 días antes de la primera dosis del tratamiento del estudio en el periodo de preinclusión abierto) y para la semana 12 (7 días antes de la visita al final de la semana 12) se derivarán de las puntuaciones diarias de la EN-S y se calcularán como el valor medio de las puntuaciones diarias de los últimos 7 días. 3. Cambio con respecto al inicio en la puntuación total y la suma de puntuaciones en el inventario de síntomas del dolor neuropático (Neuropathic Pain Symptom Inventory, NPSI): Los participantes utilizarán el cuestionario NPSI para evaluar los diferentes síntomas de dolor neuropático. El NPSI incluye diez elementos relacionados con diferentes descriptores del dolor (por ejemplo, quemazón y presión) que se evalúan en una EN de 11 puntos (0 = ausencia de síntomas y 10 = los peores síntomas imaginables). Con los datos del cuestionario se genera una puntuación para cada dimensión y una puntuación global (de 0 a 100). 4. Porcentaje de participantes con, al menos, 2 puntos de reducción con respecto al inicio en las puntuaciones medias semanales del DPD: Los participantes evaluarán su DPD mediante una EN de 11 puntos (0 = ausencia de dolor y 10 = peor dolor posible) y registrarán su puntuación en un diario electrónico. Las puntuaciones medias semanales del DPD para el inicio (7 días antes de la primera dosis del tratamiento del estudio en el periodo de preinclusión abierto) y para la semana 12 (7 días antes de la visita al final de la semana 12) se derivarán de las puntuaciones del DPD y se calcularán como el valor medio de las puntuaciones diarias de los últimos 7 días. 5. Porcentaje de participantes con, al menos, 30 % de reducción con respecto al inicio en las puntuaciones medias semanales del DPD: Los participantes evaluarán su DPD mediante una EN de 11 puntos (0 = ausencia de dolor y 10 = peor dolor posible) y registrarán su puntuación en un diario electrónico. Las puntuaciones medias semanales del DPD para el inicio (7 días antes de la primera dosis del tratamiento del estudio en el periodo de preinclusión abierto) y para la semana 12 (7 días antes de la visita al final de la semana 12) se derivarán de las puntuaciones del DPD y se calcularán como el valor medio de las puntuaciones diarias de los últimos 7 días. 6. Cantidad media semanal de analgésicos complementarios: Se supervisará el uso de analgésicos complementarios (paracetamol) y los participantes registrarán la dosis diariamente en el diario electrónico. Cantidad media semanal de analgésicos complementarios empleados para tratar el dolor neuropático durante el periodo doble ciego. 7. Impresión global del cambio por parte del paciente (Patient Global Impression of Change, PGIC): La PGIC es una escala de 7 puntos para ser completada por el paciente que describe los cambios del estado general del participante.
    Los participantes calificarán su cambio como "1 = muy mejorado", "2 = muy mejorado", "3 = mínimamente mejorado", "4 = sin cambios", "5 = mínimamente peor", "6 = mucho peor" o "7 = mucho peor". 8. Cambio desde el inicio en el Cuestionario breve sobre el dolor - Forma Corta (BPI-SF); El BPI-SF es un cuestionario autoadministrado de 7 puntos que mide cuánto ha interferido el dolor en el funcionamiento diario. Los participantes calificarán el nivel de interferencia del dolor en el funcionamiento diario en un NRS de 11 puntos donde 0 = no interfiere y 10 = interfiere completamente
    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
    1. Inicio y semana 12 del periodo doble ciego 2. Inicio y semana 12 del periodo doble ciego 3. Inicio y semana 12 del periodo doble ciego 4. Inicio y semana 12 del periodo doble ciego 5. Inicio y semana 12 del periodo doble ciego 6. Semanalmente desde el inicio a semana 12 del periodo doble ciego 7. Semana 12 del periodo doble ciego 8. Inicio y semana 12 del periodo doble ciego
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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
    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 days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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 state29
    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
    Ninguno
    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 Decision2018-01-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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