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    The EU Clinical Trials Register currently displays   43839   clinical trials with a EudraCT protocol, of which   7280   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2021-001392-17
    Sponsor's Protocol Code Number:19636
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-11-02
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2021-001392-17
    A.3Full title of the trial
    A randomized, double-blind, cross-over, placebo-controlled, multi-center, Phase 2a study to assess the safety and efficacy of BAY 2395840 in patients with diabetic neuropathic pain.
    Ensayo multicéntrico de fase IIa, aleatorizado, doble ciego, de grupos cruzados y controlado con placebo para evaluar la seguridad y eficacia de BAY 2395840 en pacientes con dolor neuropático diabético.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to learn how safe BAY 2395840 is and how well it works in participants who have diabetic nerve pain.
    Un ensayo para aprender cómo de seguro es BAY 2395840 y cómo de bien funciona en participantes que tienen dolor neuropático diabético.
    A.4.1Sponsor's protocol code number19636
    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 SponsorBayer AG
    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 supportBayer AG
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer AG
    B.5.2Functional name of contact pointClinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street AddressKaiser-Wilhelm-Allee
    B.5.3.2Town/ cityLeverkusen
    B.5.3.3Post codeD-51368
    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 nameBAY 2395840 tablets 150 mg
    D.3.2Product code BAY 2395840
    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 INNNot available yet
    D.3.9.2Current sponsor codeBAY 2395840 cholinate
    D.3.9.3Other descriptive nameBAY 2599210
    D.3.9.4EV Substance CodeSUB198776
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Neuropathic pain associated with diabetic peripheral neuropathy
    Dolor neuropático asociado con la neuropatía diabética periférica
    E.1.1.1Medical condition in easily understood language
    Diabetic nerve pain, is a condition caused by nerve damage due to diabetes.
    El dolor neuropático diabético es una condición causada por daño en los nervios debido a la 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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10067547
    E.1.2Term Diabetic peripheral neuropathic pain
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of BAY2395840 on pain associated with Diabetic neuropathic pain (DNP) as compared with placebo
    Evaluar la eficacia de BAY 2395840 sobre el dolor asociado a Dolor Neuropático Diabético (DND) en comparación con placebo.
    E.2.2Secondary objectives of the trial
    1. To evaluate the safety and tolerability of BAY2395840 on the treatment of pain associated with DNP as compared with placebo

    2. To further evaluate the efficacy of BAY2395840 on pain and associated symptoms
    1. Evaluar la seguridad y tolerabilidad de BAY 2395840 en el tratamiento del dolor asociado a DND en comparación con placebo.

    2. Evaluar más a fondo la eficacia de BAY 2395840 sobre el dolor y los síntomas asociados.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adults ≥ 18 years of age at the time of signing the informed consent.
    2. Have documented diagnosis of type 1 OR type 2 diabetes mellitus (DM)
    3. Have painful distal symmetrical sensorimotor diabetic neuropathy for at least 6 months prior to the screening and confirmed at screening via the modified Toronto Clinical Neuropathy Score with a score of at least 3.
    4. Weekly mean 24-hour average pain Numeric Rating Scale (NRS) ≥ 4 with adequate variability (not the same score on all daily pain ratings) and compliance (non-missing pain score on at least 6 out of 7 consecutive days) in daily pain recording during the 7-day NRS baseline period.
    5. Neuropathic pain according to the Douleur Neuropathique 4 Questions (DN4 questionnaire) at screening visit with a score of at least 4 out of 10.
    6.Participant should be on stable antidiabetic treatment for at least 3 months prior to the screening visit and there should be no pre-planned changes to antidiabetic treatment during this study.
    7. Participant is willing to use only rescue medication provided by the site and is willing to withdraw temporarily all other neuropathic pain medications which were in use before study participation.
    8. Participant is willing and able to use the electronic hand-held device on their own.
    9. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    1. Adultos ≥ 18 años de edad en el momento de firmar el consentimiento informado.
    2. Tener un diagnóstico documentado de diabetes mellitus (DM) de tipo 1 O tipo 2.
    3. Haber tenido neuropatía diabética sensoriomotora simétrica distal dolorosa durante al menos 6 meses antes de la selección y confirmada en la selección mediante la Puntuación de Neuropatía Clínica de Toronto modificada con una puntuación de al menos 3.
    4. Puntuación media semanal del NRS (Escala de Calificación Numérica) de dolor promedio de 24 horas ≥ 4 con una variabilidad apropiada (no la misma puntuación en todas las evaluaciones diarias de dolor) y cumplimiento adecuado (puntuación de dolor presente en al menos 6 de 7 días consecutivos) en el registro diario del dolor durante los 7 días del periodo inicial de evaluación del NRS.
    5. Dolor neuropático según el cuestionario DN4 en la visita de selección, con una puntuación de al menos 4 sobre 10.
    6. El participante debe estar en tratamiento antidiabético estable durante al menos 3 meses antes de la visita de selección y no deben haber cambios planificados en el tratamiento antidiabético durante este ensayo.
    7. El participante está dispuesto a usar únicamente la medicación de rescate proporcionada por el centro y está dispuesto a dejar de tomar temporalmente todos los demás medicamentos para el dolor neuropático que estaba usando antes de la participación en el ensayo.
    8. El participante está dispuesto y es capaz de utilizar el dispositivo electrónico portátil por su cuenta.
    9. El uso de métodos anticonceptivos por parte de hombres y mujeres debe ser congruente con las normativas locales con respecto a los métodos anticonceptivos para quienes participan en ensayos clínicos.
    E.4Principal exclusion criteria
    1.Clinically significant cardiovascular or cerebrovascular disease including Acute coronary syndrome (ACS)/myocardial infarction /stroke/Transient ischemic attack (TIA) within previous 3 months before screening visit.
    2. Major depressive episode within 6 months prior to screening. Patients with stable depression and on stable antidepressant dose (no change in medication and /or dosing regimen) for the past 6 months are allowed to participate, provided the antidepressant used is not listed under prohibited medications.
    3. Any differential diagnosis of peripheral diabetic neuropathy (PDN) including but not limited to other neuropathies (e.g. vitamin B12 deficiency, Chronic Inflammatory Demyelinating Polyneuropathy), polyradiculopathies, central disorders (e.g. demyelinating disease), or rheumatological disease (e.g. foot arthritis, plantar fasciitis).
    4. Concurrent malignancy or history of cancer (exception of basal cell or squamous cell carcinoma of the skin) within the last 5 years prior to screening.
    5. Any other diseases or conditions that according to the investigator can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study intervention (e.g. chronic bowel disease, Crohn’s disease, and ulcerative colitis).
    6. Any serious or unstable diseases or conditions including psychiatric disorders that might interfere with the conduct of the study or the interpretation of the results.
    7. Major surgery or radiological procedures (e.g. Percutaneous transluminal angioplasty (PTA) and stenting of peripheral vascular lesions in lower extremities) within 3 months before screening visit or scheduled during the study period, which might interfere pain response evaluation.
    8. Symptomatic peripheral arterial disease in lower or upper extremities, including diabetic ulcers.
    9. Use of live, attenuated, replication-competent vaccines.
    10. Previous use of strong opioids (e.g. oxymorphone, oxycodone) for neuropathic pain anytime, or topical use of capsaicin within 3 months prior to the screening visit.
    11. History or current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for study participants.
    12. Moderate-to-severe hepatic impairment defined as Child-Pugh Class B or C.
    13. Have platelets ≤ 100 x 109/L, or neutrophil count < 1.2 x 109/L (or equivalent), hemoglobin ≤ 100 g/L for women or hemoglobin ≤ 110 g/L for men at screening.
    14. Glycemic control unstable (hemoglobin HbA1c ≥11% or 97 mmol/mol) within 3 months prior to screening (e.g. ketoacidosis requiring hospitalization, any recent episode of hypoglycemia requiring assistance through medical intervention, uncontrolled hyperglycemia).
    16. ALT >2xULN, or AST >2xULN, or total bilirubin greater than ULN, or alkaline phosphatase (AP) >2x ULN, or INR greater than ULN (unless related to anticoagulation treatment) at screening.
    17. Positive hepatitis B virus surface antigen (HBsAg) or positive hepatitis C virus antibodies (anti-HCV) and detection of mRNA (HCV-mRNA tested only if hepatitis C virus antibodies detected).
    18. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2 calculated by Modification of Diet in Renal Disease (MDRD) formula.
    19. Uncontrolled hypertension despite optimal treatment with antihypertensive(s), indicated by a sitting systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg.
    1. Enfermedad cardiovascular o cerebrovascular clínicamente significativa, que incluye SCA (Síndrome Coronario Agudo)/infarto de miocardio/ictus/AIT (Accidente Isquémico Transitorio) en los 3 meses anteriores a la visita de selección.
    2. Episodio depresivo mayor en los 6 meses previos a la selección. Los pacientes con depresión estable y con una dosis estable de antidepresivos (sin cambios en la medicación y/o la pauta posológica) durante los últimos 6 meses pueden participar, siempre que el antidepresivo usado no esté incluido en la lista de medicación prohibida.
    3. Cualquier diagnóstico diferencial de neuropatía diabética periférica (NDP), incluyendo, entre otros, otras neuropatías (por ejemplo, deficiencia de vitamina B12, polineuropatía desmielinizante inflamatoria crónica), polirradiculopatías, trastornos centrales (por ejemplo, enfermedad desmielinizante) o enfermedad reumatológica (por ejemplo, artritis del pie, fascitis plantar).
    4. Neoplasia maligna concurrente o antecedentes de cáncer (a excepción del carcinoma de células basales o de células escamosas de la piel) en los últimos 5 años antes de la selección.
    5. Cualquier otra enfermedad o condición que, según el investigador, pueda comprometer la función de los sistemas corporales y pueda resultar en una absorción alterada, acumulación excesiva, metabolismo alterado o excreción alterada del fármaco del ensayo (por ejemplo, enfermedad intestinal crónica, enfermedad de Crohn y colitis ulcerosa).
    6. Cualquier enfermedad o condición grave o inestable, incluidos los trastornos psiquiátricos, que pueda interferir con la realización del ensayo o la interpretación de los resultados.
    7. Cirugía mayor o procedimientos radiológicos (por ejemplo, angioplastia transluminal percutánea y colocación de stents en lesiones vasculares periféricas en las extremidades inferiores) en los 3 meses anteriores a la visita de selección o programados durante el período de ensayo, que podrían interferir en la evaluación de la respuesta al dolor.
    8. Enfermedad arterial periférica sintomática en las extremidades inferiores o superiores, incluidas las úlceras diabéticas.
    9. Uso de vacunas vivas, atenuadas, con capacidad de replicación.
    10. Uso previo de opioides fuertes (por ejemplo, oximorfona, oxicodona) para el dolor neuropático en cualquier momento, o uso tópico de capsaicina en los 3 meses anteriores a la visita de selección.
    11. Antecedentes o diagnóstico actual de anomalías en el electrocardiograma (ECG) que indiquen un riesgo significativo de seguridad para los participantes del ensayo.
    12. Insuficiencia hepática de moderada a grave, definida como Child-Pugh Clase B o C.
    13. Recuento de plaquetas ≤ 100 x 109/L, o recuento de neutrófilos < 1,2 x 109/L (o equivalente), hemoglobina ≤ 100 g/L en las mujeres o hemoglobina ≤ 110 g/L en los hombres en la selección.
    14. Control glucémico inestable (hemoglobina HbA1c ≥ 11% o 97 mmol/mol) en los 3 meses previos a la selección (por ejemplo, cetoacidosis que requiera hospitalización, cualquier episodio reciente de hipoglucemia que requiera asistencia mediante intervención médica, hiperglucemia no controlada).
    16. ALT > 2x LSN, o AST > 2x LSN, o bilirrubina total por encima del LSN, o fosfatasa alcalina (FA) > 2x LSN, o INR por encima del LSN (a menos que esté relacionado con el tratamiento anticoagulante) en la selección.
    17. Antígeno de superficie del virus de la hepatitis B (HBsAg) positivo o anticuerpos del virus de la hepatitis C (anti-VHC) positivos y detección de ARNm (el ARNm del VHC solo se analiza si se detectan anticuerpos contra el virus de la hepatitis C).
    18. Tasa de filtración glomerular estimada (TFGe) < 30 mL/min/1,73 m2 calculada mediante la fórmula de Modificación de la dieta en la enfermedad renal (MDRD).
    19. Hipertensión no controlada a pesar de un tratamiento óptimo con antihipertensivo(s), indicada por una presión arterial sistólica en posición sentada ≥ 180 mmHg y /o presión arterial diastólica ≥ 110 mmHg.
    E.5 End points
    E.5.1Primary end point(s)
    1. Change in weekly mean 24-hour average pain intensity score using the 11-point Numeric Rating Scale (NRS) from baseline to the end of intervention.

    2. Change in weekly mean 24-hour average pain intensity score using the 11-point Numeric Rating Scale (NRS) from baseline to the end of intervention.
    1. Cambio en la puntuación media semanal de la intensidad del dolor promedio de 24 horas utilizando la Escala de Calificación Numérica (NRS, por sus siglas en inglés) de 11 puntos desde el inicio hasta el final de la intervención.

    2. Cambio en la puntuación media semanal de la intensidad del dolor promedio de 24 horas utilizando la Escala de Calificación Numérica (NRS, por sus siglas en inglés) de 11 puntos desde el inicio hasta el final de la intervención.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Part A: from baseline to end of intervention (in total up to 9 weeks).

    2. Part B: from baseline to end of intervention (in total up to 12 weeks).
    1. Parte A: desde el inicio hasta el final de la intervención (en total hasta 9 semanas).

    2. Parte B: desde el inicio hasta el final de la intervención (en total hasta 12 semanas).
    E.5.2Secondary end point(s)
    1. Number of participants with treatment emergent adverse events

    2. Change in Neuropathic Pain Symptom Inventory (NPSI) total score from baseline to the end of intervention.

    3. Change in Patient Global Impression of Severity (PGI-S) from baseline to the end of intervention.

    4. The proportion of participants achieving a ≥30% and a ≥50% reduction in weekly mean 24-hour average pain intensity score (i.e. responder rates using NRS)
    1. Número de participantes con acontecimientos adversos aparecidos durante el tratamiento.

    2. Cambio en la puntuación total del Inventario de Síntomas de Dolor Neuropático (NPSI, por sus siglas en inglés) desde el inicio hasta el final de la intervención.

    3. Cambio en la impresión global de gravedad del paciente (PGI-S, por sus siglas en inglés) desde el inicio hasta el final de la intervención.

    4. La proporción de participantes que lograron una reducción ≥ 30 % y ≥ 50 % en la puntuación media semanal de la intensidad del dolor promedio de 24 horas (es decir, las tasas de respuesta mediante NRS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.From start of study intervention to 14 days after last dose.

    2. At visit 2, visit 4, visit 6, visit 8, visit 10 and at visit 12 end of intervention (EOI).

    3.At visit 2, visit 4, visit 6, visit 8, visit 10 and at visit 12 end of intervention (EOI).

    4. From baseline to end of intervention (in total up to 12 weeks).
    1. Desde el inicio de la intervención del ensayo hasta 14 días después de la última dosis.

    2. En la visita 2, visita 4, visita 6, visita 8, visita 10 y visita 12 final de la intervención (EOI).

    3. En la visita 2, visita 4, visita 6, visita 8, visita 10 y visita 12 final de la intervención (EOI).

    4. Desde el inicio hasta el final de la intervención (en total hasta 12 semanas).
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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. 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 Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    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
    The end of the study is defined as the date of the last scheduled call /visit / procedure of the last participant in the study.
    El final del ensayo se define como la fecha de la última llamada / visita / procedimiento programado del último participante en el ensayo.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days0
    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: 75
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 75
    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)
    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 Decision2022-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-22
    P. End of Trial
    P.End of Trial StatusOngoing
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