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    Summary
    EudraCT Number:2019-002627-16
    Sponsor's Protocol Code Number:IRL752C003
    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:2022-03-31
    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 number2019-002627-16
    A.3Full title of the trial
    A randomised, placebo-controlled, multicentre phase IIb study evaluating the efficacy of pirepemat on falls frequency in patients with Parkinson’s disease
    Estudio de fase IIb, aleatorizado, controlado por placebo, multicéntrico para evaluar la eficacia de pirepemat en la frecuencia de caídas en pacientes con enfermedad de Parkinson
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study for evaluation of the efficacy of pirepemat on falls frequency in patients with Parkinson’s disease
    Estudio para la evlauacion de la eficacia de Pirepemat en la frecuencia de caídas en pacientes con enfermedad de Parkinson
    A.4.1Sponsor's protocol code numberIRL752C003
    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 SponsorIntegrative Research Laboratories Sweden AB (IRLAB)
    B.1.3.4CountrySweden
    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 supportIntegrative Research Laboratories Sweden AB (IRLAB)
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIntegrative Research Laboratories Sweden AB (IRLAB)
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressArvid Wallgrens Backe 20
    B.5.3.2Town/ cityGöteborg
    B.5.3.3Post code413 46
    B.5.3.4CountrySweden
    B.5.4Telephone number+4631 757 38 00
    B.5.6E-mailinfo@irlab.se
    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 namePirepemat, 50 mg
    D.3.2Product code IRL752
    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 INNPirepemat
    D.3.9.2Current sponsor codeIRL752
    D.3.9.3Other descriptive namePirepemat x fumarate
    D.3.9.4EV Substance CodeSUB217567
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 namePirepemat, 100 mg
    D.3.2Product code IRL752
    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 INNPirepemat
    D.3.9.2Current sponsor codeIRL752
    D.3.9.3Other descriptive namePirepemat x fumarate
    D.3.9.4EV Substance CodeSUB217567
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Parkinson’s disease
    Enfermedad de Parkinson
    E.1.1.1Medical condition in easily understood language
    Parkinson’s disease
    Enfermedad de Parkinson
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10061536
    E.1.2Term Parkinson's disease
    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
    To evaluate the effects of pirepemat on falls frequency as compared to placebo.
    Evaluar los efectos de Pirepemat en la frecuencia de caídas comparado con placebo
    E.2.2Secondary objectives of the trial
    To evaluate the effects of pirepemat on cognitive function as compared to placebo.
    To evaluate the effects of pirepemat on postural dysfunction compared to placebo.
    To evaluate the effects of pirepemat on Parkinson's disease motor symptoms as compared to placebo.
    To evaluate the effects of pirepemat on apathy as compared to placebo.

    Other objectives:
    To evaluate the effects of pirepemat on Parkinson's disease symptoms
    and severity as compared to placebo.
    To evaluate the effects of pirepemat on postural dysfunction as
    compared to placebo.
    To evaluate the safety and tolerability of pirepemat
    Evaluar los efectos de pirepemat en la función cognitiva en comparación con el placebo.
    Evaluar los efectos de pirepemat en la disfunción postural en comparación con el placebo.
    Evaluar los efectos de pirepemat en los síntomas motores de la enfermedad de Parkinson en comparación con el placebo.
    Evaluar los efectos de pirepemat en la apatía en comparación con el placebo.

    Otros objetivos:
    Evaluar los efectos de pirepemat en los síntomas y severidad de la enfermedad de Parkinson comparado con placebo
    Evaluar los efectos de pirepemat en la disfunción postural comparada con placebo
    Evaluar la seguridad y tolerabilidad de pirepemat
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female 55-85 years of age, inclusive.
    2. Diagnosis of idiopathic Parkinson's disease, according to the UK Parkinson's disease Society Brain Bank criteria.
    3. Montreal Cognitive Assessment (MoCA) score of ≥10 and <26 at screening.
    4. A modified Hoehn & Yahr score of ≥2.5 in “on”.
    5. Having experienced recurrent falls during the past 3 months (based on interview with the patient and/or caregiver) and at least 2 falls during the past 4 weeks before baseline.
    6. On a stable regimen of anti-Parkinson's medications for at least 30 days prior to baseline, and willing to continue the same doses and regimens during study participation.
    7. Able to cooperate and participate in study related procedures. This includes the ability to accurately complete a falls diary. The falls diary may also be completed by a responsible caregiver. For patients meeting DSM-IV TR criteria for Parkinson’s disease dementia, the falls diary should be completed by the caregiver.
    8. Availability of a responsible caregiver at least five days per week at least 2 hours per day. For patients meeting DSM-IV TR criteria for Parkinson’s disease dementia, availability of a responsible live-in caregiver is required.
    9. Female patients must be of non-childbearing potential (defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or post-menopausal females defined as 12 months of amenorrhoea [in questionable cases a blood sample with simultaneous follicle stimulation hormone (FSH) 25-140 IE/L and oestradiol <200 pmol/L is confirmatory]).
    10. Fertile male patients must be willing to use condom and refrain from donating sperm during the study and until 3 months after last dosing of IMP and ensure that their fertile female partners are using contraceptive methods to prevent pregnancy1.
    11. Written informed consent for participation in the study given by the patient and the responsible caregiver.
    1.Varón o mujer de 55-85 años de edad, inclusive.
    2.Diagnóstico de enfermedad de Parkinson idiopática, de acuerdo con los criterios del UK Parkinson’s disease Society Brain Bank.
    3.Puntuación de la Evaluación Cognitiva de Montreal (Montreal Cognitive Assessment, MoCA) de ≥10 y <26 en la selección.
    4.Una puntuación de la escala de Hoehn y Yahr modificada de ≥2,5 en «ON».
    5.Haber sufrido caídas recurrentes durante los últimos 3 meses (basándose en la entrevista con el paciente y/o el cuidador) y al menos 2 caídas durante las últimas 4 semanas previas al inicio.
    6.Con una pauta estable de medicamentos contra el Parkinson durante al menos 30 días antes del inicio y dispuesto a continuar con las mismas dosis y pautas durante la participación en el estudio.
    7.Capacidad de cooperar y participar en procedimientos relacionados con el estudio. Se incluye la habilidad de cumplimentar de forma precisa un diario de caídas. A su vez, el diario de caídas también puede cumplimentarlo un cuidador responsable. Para pacientes que cumplan los criterios del DSM-IV TR para la demencia de la enfermedad de Parkinson, el diario de caídas debe cumplimentarlo el cuidador.
    8.Disponibilidad de un cuidador responsable durante al menos cinco días a la semana con al menos 2 horas al día. Para pacientes que cumplan los criterios del DSM-IV TR para la demencia de la enfermedad de Parkinson, se requiere la disponibilidad de un cuidador responsable interno.
    9.Las pacientes no deben tener capacidad para quedarse embarazadas (definido como mujeres premenopáusicas con una ligadura de trompas o histerectomía documentada; o mujeres posmenopáusicas, definidas como aquellas con 12 meses de amenorrea [en caso de duda, se confirma con una muestra de sangre tanto con 25-140 IE/l de hormona foliculoestimulante (FSH) como con <200 pmol/l de estradiol]).
    10.Los pacientes varones fértiles deben estar dispuestos a usar preservativo y abstenerse de donar esperma durante el estudio y hasta 3 meses después de la última administración del PEI y asegurarse de que sus parejas fértiles de sexo femenino usan métodos anticonceptivos para evitar el embarazo .
    11.Consentimiento informado por escrito para la participación en el estudio otorgado tanto por el paciente como por el cuidador responsable.
    E.4Principal exclusion criteria
    1. Any of the following potential hepatic conditions:
    a. known history of alcohol abuse, chronic liver or biliary disease, with the exception of Gilbert’s syndrome
    b. total bilirubin greater than the upper limit of the normal range (unless associated with isolated instances of suspected Gilbert’s syndrome)
    c. alkaline phosphatase (ALP) greater than 1.5 times the upper limit of the normal range
    d. aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 2 times the upper limit of the normal range
    e. history of repeated unexplained upper right quadrant abdominal pain and/or nausea, or jaundice
    2. A positive Hepatitis B surface antigen or a positive Hepatitis C antibody result.
    3. A score of 5 (wheelchair bound or bedridden) in the "on"-state on the modified Hoehn & Yahr scale.
    4. Uncontrolled symptomatic orthostatic hypotension.
    5. Clinically significant polyneuropathy.
    6. Weight <55 kg at Screening.
    7. Patients with current or past treatment with deep brain stimulation (DBS) or patients with previous history of stereotaxic brain surgery for PD.
    8. A current diagnosis of any primary neurodegenerative disorder other than idiopathic PD.
    9. A current diagnosis of any treatable dementia (hypothyroidism, syphilis, vitamin B12 or folate deficiency) that is verified by the investigator to be the cause of dementia.
    10. A current diagnosis of a major depressive episode according to DSM-IV criteria.
    11. Patient has delirium.
    12. Any history of a heart condition, including prolonged QTc (>450 ms for males and > 470 ms for females, QTcF and/or QTcB), cardiac arrhythmias, any repolarisation deficits or any other clinically significant abnormal ECG as judged by the Investigator.
    13. Severe or ongoing unstable medical condition including a history of poorly controlled diabetes; obesity associated with metabolic syndrome; uncontrolled hypertension; cerebrovascular disease, or any form of clinically significant cardiac disease; renal failure, history of abnormal renal function.
    14. History of seizures within two years of screening.
    15. History of cancer within five years prior to screening, with the following exceptions: adequately treated non-melanomatous skin cancers, localised bladder cancer, non-metastatic prostate cancer or in situ cervical cancer.
    16. History of severe allergy/hypersensitivity or on-going allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to pirepemat.
    17. Creatinine clearance <30 mL/min (calculated according to the Cockroft-Gault formula).
    18. Treatment with Warfarin within three months before study treatment.
    19. Treatment with Amantadine within 6 weeks before study treatment.
    20. Treatment with Selegiline within 6 weeks before study treatment.
    21. Administration of another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment with less than three months between administration of last dose and first dose of IMP in this study.
    22. Current or history of drugs of abuse according to DSM-IV criteria.
    23. Any planned major surgery within the duration of the study.
    24. Any other condition or symptoms preventing the patient from entering the study, according to the Investigator’s judgement.
    Where the clinical significance of an abnormal Screening test result (lab or any other tests) is considered uncertain, the test may be repeated once, at the discretion of the Investigator, as long as the repeat test result is available within the 6 weeks screening period to determine eligibility.
    1.Cualquiera de las siguientes posibles enfermedades hepáticas:
    a.antecedentes conocidos de alcoholismo, enfermedad biliar o hepática crónica, a excepción del síndrome de Gilbert
    b.bilirrubina total superior al límite superior del intervalo normal (a menos que esté asociado con casos aislados de sospecha de síndrome de Gilbert)
    c.fosfatasa alcalina (FA) superior a 1,5 veces el límite superior del intervalo normal
    d.aspartato aminotransferasa (AST) o alanina aminotransferasa (ALT) superior a 2 veces el límite superior del intervalo normal
    e.antecedentes de dolor abdominal del cuadrante superior derecho repetido y sin explicación, y/o náuseas, o ictericia
    2.Resultado positivo de la prueba del antígeno de superficie de la hepatitis B o de detección de anticuerpos de la hepatitis C.
    3.Puntuación de 5 (permanece en silla de ruedas o postrado en cama) en el estado «ON» de la escala de Hoehn y Yahr modificada.
    4.Hipotensión ortostática sintomática no controlada.
    5.Polineuropatía clínicamente significativa.
    6.Peso de <55 kg en la selección.
    7.Pacientes con tratamiento actual o previo de estimulación cerebral profunda (DBS, en inglés) o pacientes con antecedentes de cirugía cerebral estereotáxica para la EP.
    8.Diagnóstico actual de alguna enfermedad neurodegenerativa primaria distinta a la EP idiopática.
    9.Diagnóstico actual de alguna demencia tratable (hipotiroidismo, sífilis, deficiencia de vitamina B12 o folato) que el investigador verifique que es la causa de la demencia.
    10.Diagnóstico actual de un episodio depresivo mayor de acuerdo con los criterios del DSM-IV.
    11.El paciente tiene delirios.
    12.Cualquier antecedente de enfermedad cardíaca, incluido un intervalo QTc prolongado (QTcF y/o QTcB de >450 ms en varones y >470 ms en mujeres), arritmias cardíacas, cualquier déficit de repolarización y cualquier otro ECG anómalo clínicamente significativo a juicio del investigador.
    13.Enfermedad inestable en curso o grave, incluidos antecedentes de diabetes con control deficiente; obesidad asociada con el síndrome metabólico; hipertensión no controlada; enfermedad cerebrovascular o cualquier otra forma de enfermedad cardíaca clínicamente significativa; insuficiencia renal; antecedentes de función renal anómala.
    14.Antecedentes de convulsiones en los dos años previos a la selección.
    15.Antecedentes de cáncer en los cinco años previos a la selección, con las siguientes excepciones: cánceres de piel no melanomatosos tratados adecuadamente, cáncer de vejiga localizado, cáncer de próstata no metastásico o cáncer del cuello uterino in situ.
    16.Antecedentes de hipersensibilidad/alergia grave o hipersensibilidad/alergia en curso, a juicio del investigador, o antecedentes de hipersensibilidad a fármacos con una estructura química o clase similar a la de pirepemat.
    17.Depuración de la creatinina de <30 ml/min (calculada de acuerdo con la fórmula de Cockroft-Gault).
    18.Tratamiento con warfarina en los tres meses previos al tratamiento del estudio.
    19.Tratamiento con amantadina en las 6 semanas previas al tratamiento del estudio.
    20.Tratamiento con selegilina en las 6 semanas previas al tratamiento del estudio.
    21.Administración de otra nueva entidad química (definida como un compuesto que no se haya aprobado para su comercialización) o ha participado en cualquier otro estudio clínico que incluyera un tratamiento farmacológico con menos de tres meses entre la administración de la última dosis y la primera dosis del PEI del presente estudio.
    22.Drogadicción actual o antecedentes de drogadicción de acuerdo con los criterios del DSM-IV.
    23.Cualquier otra cirugía mayor prevista durante el transcurso del estudio.
    24.Cualquier otra enfermedad o síntoma que impida al paciente inscribirse en el estudio, a juicio del investigador.
    En el caso de que la transcendencia clínica de un resultado anómalo de una prueba de la selección (analítica o de otro tipo) se considere incierta, la prueba debe repetirse una vez, a discreción del investigador, siempre que el resultado de la prueba repetida esté disponible en el periodo de selección de 6 semanas para determinar la idoneidad del paciente.
    E.5 End points
    E.5.1Primary end point(s)
    Change in falls frequency from baseline period (4 weeks prior to
    randomisation) to the end of treatment visit as assessed by falls diary.
    Cambio en la frecuencia de caídas desde el período inicial (4 semanas antes de randomizacion) hasta el final de la visita de tratamiento según lo evaluado por el diario de caídas.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at every visit during the treatment period
    En cualquier visita durante el periodo de tratamiento
    E.5.2Secondary end point(s)
    Change in total MoCA score from baseline to end of treatment
    Change in MDS-UPDRS item 3.12 (postural stability) from baseline to end of treatment
    Change in the total score of MDS-UPDRS part 2 (M-EDL) from baseline to end of treatment
    Change in total score (Frequency*Severity) and Caregiver distress of NPI Item G (Apathy/Indifference) from baseline to end of treatment

    Safety objective:
    As measured by subject incident of treatment-emergent adverse events,
    clinically significant changes in vital signs and physical examination
    clinical laboratory safety tests, and ECGs.
    Cambio en la puntuación MoCA total desde el inicio hasta el final del tratamiento
    Cambio en el ítem 3.12 (estabilidad postural) de la MDS-UPDRS desde el inicio hasta el final del tratamiento
    Cambio en la puntuación total de la parte 2 (M-EDL) de la MDS-UPDRS desde el inicio hasta el final del tratamiento
    Cambio en la puntuación total (frecuencia*gravedad) y en el sufrimiento del cuidador del ítem G (apatía/indiferencia) del NPI desde el inicio hasta el final del tratamiento

    Objetivo de seguridad
    Medido como la incidencia en el sujeto de eventos adversos emergentes del tratamiento,
    cambios clínicamente significativos en los signos vitales y el examen físico,
    pruebas de seguridad de laboratorio clínico y ECG.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline to end of treatment:
    MoCA - V1, V2, V5, V8
    MDS-UPDRS - V1, V2, V5, V8
    NPI - V2, V5, V8
    Safety objective timepoints: every visit
    Desde el inicio hasta el final del tratamiento
    MoCA - V1, V2, V5, V8
    MDS-UPDRS - V1, V2, V5, V8
    NPI - V2, V5, V8
    Momento de evaluación del objetivo de seguridad: en cada visita
    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 Yes
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA39
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 clinical part of the study is defined as the last visit of the last patient participating in the study.
    El final de la parte clínica del estudio se define como la ultima visita del ultimo paciente participante en el estudio
    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 months9
    E.8.9.1In the Member State concerned days17
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days17
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 115
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 165
    F.4.2.2In the whole clinical trial 165
    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)
    The patients will continue on the standard of care for this indication.
    Los pacientes continuaran con el tratamiento clínico habitual para esta indicacion
    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 Decision2022-03-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-11
    P. End of Trial
    P.End of Trial StatusOngoing
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