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    Summary
    EudraCT Number:2021-001989-38
    Sponsor's Protocol Code Number:IMCRELA
    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:2021-06-14
    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 number2021-001989-38
    A.3Full title of the trial
    IMPACT OF THE COMBINED TREATMENT OF THE LIPOSOMATED POLYPHENOLS CÚRCULA AND RESVERATROL® WITH DUTASTERIDE, IN THE CLINICAL IMPROVEMENT OF PATIENTS WITH ALS TREATED WITH RILUZOLE
    IMPACTO DEL TRATAMIENTO COMBINADO DE LOS POLIFENOLES LIPOSOMADOS CÚRCULA Y RESVERATROL® CON DUTASTERIDA, EN LA MEJORA CLÍNICA DE PACIENTES CON ELA TRATADOS CON RILUZOL
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    COMPARISON OF THE COMBINED TREATMENT OF THE LIPOSOMATED POLYPHENOLS CÚRCULA AND RESVERATROL® WITH DUTASTERIDE, IN THE IMPROVEMENT OF PATIENTS WITH ELA WHO ARE BEING TREATED WITH RILUZOLE
    COMPARACION DEL TRATAMIENTO COMBINADO DE LOS POLIFENOLES LIPOSOMADOS CÚRCULA Y RESVERATROL® CON DUTASTERIDA, EN LA MEJORA DE PACIENTES CON ELA QUE ESTÉN SIENDO TRATADOS CON RILUZOL
    A.3.2Name or abbreviated title of the trial where available
    IMCRELA
    IMCRELA
    A.4.1Sponsor's protocol code numberIMCRELA
    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 SponsorFacultad de medicina y ciencias de la salud de la Universidad Católica de Valencia
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFACULTAD DE MEDICINA Y CIENCIAS DE LA SALUD DE LA UNIVERSIDAD CATÓLICA DE VALENCIA
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFACULTAD DE MEDICINA Y CIENCIAS DE LA SALUD DE LA UNIVERSIDAD CATÓLICA DE VALENCIA
    B.5.2Functional name of contact pointCarlos Barrios
    B.5.3 Address:
    B.5.3.1Street Address2, Quevedo St.
    B.5.3.2Town/ cityValencia
    B.5.3.3Post code46001
    B.5.3.4CountrySpain
    B.5.6E-mailcarlos.barrios@ucv.es
    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 Yes
    D.2.1.1.1Trade name Dutasterida
    D.2.1.1.2Name of the Marketing Authorisation holderIndustria Química y Farmacéutica VIR, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameDutasterida
    D.3.4Pharmaceutical form Capsule, soft
    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 INNDUTASTERIDE
    D.3.9.1CAS number 164656-23-9
    D.3.9.3Other descriptive nameDUTASTERIDE
    D.3.9.4EV Substance CodeSUB06430MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 placeboCapsule, soft
    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
    Amyotrophic Lateral Sclerosis
    Esclerosis lateral amiotrófica
    E.1.1.1Medical condition in easily understood language
    Amyotrophic Lateral Sclerosis
    Esclerosis lateral amiotrófica- ELA
    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 PT
    E.1.2Classification code 10002026
    E.1.2Term Amyotrophic lateral sclerosis
    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 assess the functional improvement of the combined treatment with Liposomal Turmeric / Resveratrol® with Dutasteride in comparison with patients in routine clinical practice
    Valorar la mejoría funcional del tratamiento combinado con Liposomal Cúrcuma/Resveratrol® con Dutasterida en comparación con pacientes en práctica clínica habitual
    E.2.2Secondary objectives of the trial
    •Assess activity at the cognitive and behavioral level in ALS patients, and its effects on the quantity and quality of sleep, after the intervention with the combination of Liposomal Turmeric / Resveratrol® with Dutasteride, at baseline visit, 3 and 6 months.
    •Quantify the decrease in oxidative stress, after the intervention with the indicated drug combination, at the baseline visit, 3 and 6 months.
    •Quantify the possible decrease in inflammation, after the intervention with the indicated drug combination, at a baseline visit, 3 and 6 months.
    •Assess the effects on the intestinal microbiota, after the intervention with the indicated drug combination, related to cognitive and behavioral changes at the beginning, 3 and 6 months.
    •Assessment of muscle strength and capacity at baseline visit, 3 and 6 months after onset.
    •Assessment of the quantity and quality of sleep, after the intervention with the indicated combination of medications, at a baseline visit, 3 and 6 months.
    •Valorar la actividad a nivel cognitivo y conductual en pacientes de ELA, y sus efectos en la cantidad y calidad de sueño, tras la intervención con la combinación de Liposomal Cúrcuma/Resveratrol® con Dutasterida, en visita basal, 3 y 6 meses de inicio del tto.
    •Cuantificar la disminución de estrés oxidativo, tras la intervención con la combinación de medicamentos indicado, en visita basal, 3 y 6 meses.
    •Cuantificar la posible disminución de inflamación, tras la intervención con la combinación de medicamentos indicado, en visita basal, 3 y 6 meses.
    •Valorar los efectos en la microbiota intestinal, tras la intervención con la combinación de medicamentos indicado, relacionados con los cambios cognitivos, y conductuales al inicio, 3 y6 meses.
    •Valoracion de la fuerza y capacidad muscular en visita basal, a los 3 y 6 meses de inicio.
    •Valoración de la cantidad y calidad de sueño, tras la intervención con la combinación de de medicamentos indicado, en visita basal, 3 y 6 meses.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Male patients over 18 years of age or female patients over 50 years of age who are not fertile, and between 18 and 50 years of age who have accepted the use of contraceptives if they are of childbearing age and renounce becoming pregnant during the intervention.
    •Patients diagnosed and symptomatic of ALS for at least 6 months prior to inclusion in the study.
    •Patients treated with Riluzole at least one month before inclusion in the study.
    •Acceptance of participation in the study by signing the IC form.
    •At the discretion of the investigator, the patient must be able to meet the requirements of the study
    •Pacientes varones mayores de 18 años ó pacientes mujeres mayores de 50 años no fértiles, y entre 18 y 50 años que hayan aceptado el uso de anticonceptivos si se encuentran en edad fértil renunciando a quedarse embarazadas durante la intervención.
    •Pacientes diagnosticados y sintomáticos de ELA desde al menos 6 meses previos a la inclusión en el estudio.
    •Pacientes tratados con Riluzol mínimo un mes antes de la inclusión en el estudio.
    •Aceptación de participación en el estudio mediante la firma del formulario de CI.
    •A criterio del investigador, el paciente debe ser capaz de cumplir con los requisitos del estudio
    E.4Principal exclusion criteria
    •Patients with tracheostomy.
    •Patients with invasive or non-invasive ventilation with positive ventilatory pressure.
    •Participation in any other trial or in the 4 weeks prior to inclusion.
    •Gastro-stomized patients.
    •We are ill with evidence of dementia.
    •We are ill with dependence on alcohol or drug abuse.
    •Patients infected with hepatitis B or C, or HIV positive.
    •Kidney patients with creatinine 2 times higher than normal markers 30 days before inclusion.
    9.Hepatic patients with hepatic markers (ALT, AST) elevated 3 times above normal levels 30 days prior to enrollment.
    10.Patients treated with anticoagulants or with hemostatic problems 30 days before inclusion.
    •Pacientes con traqueotomía.
    •Pacientes con ventilación invasiva o no invasiva con presión ventilatoria positiva.
    •Participación en cualquier otro ensayo o en las 4 semanas previas a la inclusión.
    •Pacientes gastroestomizados.
    •Enfermos con evidencia de demencia.
    •Enfermos con dependencia de abuso de alcohol o drogas.
    •Pacientes infectados de hepatitis B o C, o HIV positivo.
    •Pacientes renales con creatinina 2 veces superior a los marcadores normales30 días antes de la inclusión.
    •Pacientes hepáticos con marcadores hepáticos (ALT, AST) elevados 3 veces por encima de los niveles normales 30 días antes de la inclusión.
    •Enfermos tratados con anticoagulantes o con problemas hemostáticos 30 días antes de la inclusión.
    E.5 End points
    E.5.1Primary end point(s)
    Determine functional improvement, understanding as such a statistically significant increase in the mean score obtained on the revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRR-R) associated with ALS with respect to the baseline visit, at 3 and 6 months. treatment.
    Determinar mejoría funcional entendiendo como tal un aumento estadísticamente significativo de la media de la puntuación obtenida en la escala Escala Amyotrophic Lateral Sclerosis Functional Rating Scale revisada (ALSFRR-R) asociada a la ELA respecto a la visita basal, a los 3 y a los 6 meses del tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    9 months
    9 meses
    E.5.2Secondary end point(s)
    - Motor Variables: The scales and tests carried out will try to determine improvement in muscular and respiratory activity, which deteriorates due to motor neuron damage.
    The tests will be the following:
    • Electromyography (EMG). Graphic recording technique of the electrical activity produced by skeletal muscles. EMG can be monitored through electrodes inserted into the muscles (intramuscular electrodes) or through electrodes on the surface of the skin over the muscle (superficial electrodes) with the FREE-EMG 300 Electromyograph (8 CHANNELS). This EMG is electromyographic data acquisition and analysis software. In this version, 8 acquisition channels are considered that allow the acquisition of EMG, Switch and / or Force Cell data. The graphical interface is designed for a 1280 x 1024 screen area.
    • TEST MRC 11 –steps-mrc grading scale measures muscle strength
    • Measurement of forced vital capacity (FVC): FVC is an indicator of lung capacity and would be obtained by performing spirometry, measuring it using a peak expiratory flow meter.
    - Variables for cognitive and behavioral assessment: The assessment of cognitive and behavioral functions will try to determine possible improvements in these functions, linked to the damage that occurs in the frontotemporal area of ​​the cortex in patients with ALS. To carry out these assessments, the following cognitive and behavioral tests will be applied.
    The tests will be:
    • Edinburgh ELA Cognitive and Behavioral Exam (ECCE)
    • A behavioral test-interview with the caregiver that asks questions with a dichotomous answer Y / N about the presence of uninhibited behavior, apathy or behavioral inertia, lack of sympathy or empathy, perseverative, stereotyped, compulsive or ritualistic behavior, as well as hyperorality and alteration of eating behavior. Likewise, it collects 3 questions about the possible presence of psychotic symptoms.
    -Variables related to the microbiota: A Clinical Intestinal Microbiome will be carried out, which is an analysis of the bacterial microbiota present in the intestine, from a stool sample. With this test the improvement will be assessed by the percentage of patients who present a increase of Akkermansia muciniphila, bifidobacterium or lactobacillus (the increase of any of the 3, especially the first); or a decrease in Escherichia coli or Ruminococcus torques (either of the two, but especially the second) at baseline, at 3 months (according to the investigator), and at 6 months.
    -Variables related to the quantity and quality of sleep:
    • Clinical questionnaire for screening of sleep pathologies, hereinafter, sleep test (TS)
    • Measurement through diaries (DS) and scales (ES) of multiple quantitative and qualitative sleep variables (Epworth Test (sleepiness) and Pittsburgh Test (sleep quality)).
    -Variables related to inflammation and oxidation:
    • Quantitative measurement of plasma IL-6 and TNF-alpha.
    • Quantitative measurement of plasma CRP.
    • Quantitative measurement of plasma haptoglobin.
    • Quantitative assessment of TEAC (oxidation).
    • Quantitative measurement of plasma 8-oxoG.
    • Quantitative measurement of plasma MDA.
    - Variables Motoras:Las escalas y pruebas realizadas tratarán de determinar mejoría en la actividad muscular y respiratoria, que se deteriora por el daño de las motoneuronas.
    Los tests serán los siguientes:
    •Electromiografía (EMG). Técnica de registro gráfico de la actividad eléctrica producida por los músculos esqueléticos. El EMG puede ser monitoreado a través de electrodos insertados dentro de los músculos (electrodos intramusculares) o a través de electrodos en la superficie de la piel sobre el músculo (electrodos superficiales) con Electromiógrafo FREE-EMG 300 (8 CANALES). Este EMG es un software de adquisición y análisis de datos electromiográficos. En esta versión se consideran 8 canales de adquisición que permiten adquirir datos EMG, Switch y/o Celda de Fuerza. La interfaz gráfica está diseñada para un área de pantalla de 1280 x 1024.
    •TEST MRC 11 –steps-mrc grading scale mide la fuerza muscular
    •Medición de la capacidad vital forzada (CVF): CVF es un indicador de capacidad pulmonar y se obtendría mediante la realización de una espirometría, midiéndolo mediante un medidor de flujo espiratorio máximo.
    - Variables para la valoración cognitiva y conductual: La valoración de las funciones cognitivas y conductuales, tratarán de determinar posibles mejoras en estas funciones, vinculadas con los daños que se producen en la zona frontotemporal de la corteza en enfermos de ELA. Para realizar estas valoraciones, se aplicarán los siguientes test tanto cognitivos como conductuales.
    Las pruebas serán:
    •Examen cognitivo y conductual de ELA de Edimburgo (ECCE)
    •Un examen conductual-entrevista con el cuidador que plantea preguntas con respuesta dicotómica S/N sobre la presencia de conducta desinhibida, apatía o inercia comportamental, falta de simpatía o empatía, conducta perseverativa, estereotipada, compulsiva o ritualista, así como hiperoralidad y alteración de la conducta alimentaria. Así mismo, recoge 3 cuestiones sobre la posible presencia de sintomatología psicótica.
    -Variables relacionadas con la microbiota: Se realizará un Microbioma Intestinal Clínico, que es un análisis de la microbiota bacteriana presente en el intestino, a partir de una muestra de heces.Con este test se valorará la mejoría mediante el porcentaje de pacientes que presenten un aumento de Akkermansia muciniphila, bifidobacterium o lactobacillus (el aunmento de cualquiera de las 3, especialmente la primera); o una disminución de Escherichia coli o Ruminococcus torques (cualquiera de las dos, pero especialmente la segunda) al inicio, a los 3 meses (a juicio del investigador) y a los 6 meses.
    -Variables relacionadas con la cantidad y calidad de sueño:
    •Cuestionario clínico para screening de patologías de sueño, en adelante, test de sueño (TS)
    •Medición mediante diarios (DS) y escalas (ES) de múltiples variables cuantitativas y cualitativas de sueño (Test Epworth (somnolencia) y Test de Pittsburgh (calidad de sueño)).
    -Variables relacionadas con inflamación y oxidación:
    •Medición cuantitativa de IL-6 y TNF-alfa plasmáticos.
    •Medición cuantitativa de PCR plasmática.
    •Medición cuantitativa de haptoglobina plasmática.
    •Valoración cuantitativa de TEAC (oxidación).
    •Medición cuantitativa de 8-oxoG plasmática.
    •Medición cuantitativa de MDA plasmático.
    E.5.2.1Timepoint(s) of evaluation of this end point
    9 months
    9 meses
    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 No
    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
    Low-intervention pilot clinical trial, phase IIb, single-center exploratory, randomized, single-blind, placebo-controlled trial.
    Ensayo clínico piloto de baja intervención, fase IIb, unicéntrico de tipo exploratorio, aleatorizado simple ciego controlado con placebo.
    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 Yes
    E.8.1.4Double blind No
    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) Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 No
    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
    LPLV
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    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: 100
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state100
    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 Decision2021-07-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-31
    P. End of Trial
    P.End of Trial StatusOngoing
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