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    Summary
    EudraCT Number:2018-000203-16
    Sponsor's Protocol Code Number:SOMCT02
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-05-21
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2018-000203-16
    A.3Full title of the trial
    Phase IIa, double-blind, randomized, placebo-controlled study of the efficacy and safety of SOM3335 in Huntington`s disease (HD) patients with chorea movements.
    Estudio de fase IIa, doble ciego, aleatorizado y controlado con placebo, para evaluar la eficacia y seguridad de SOM3355 en pacientes con movimientos coreicos asociados a la enfermedad de Huntington.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase IIa, double-blind, randomized, placebo-controlled study of the efficacy and safety of SOM3335 in Huntington`s disease (HD) patients with chorea movements.
    Estudio de fase IIa, doble ciego, aleatorizado y controlado con placebo, para evaluar la eficacia y seguridad de SOM3355 en pacientes con movimientos coreicos asociados a la enfermedad de Huntington.
    A.4.1Sponsor's protocol code numberSOMCT02
    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 SponsorSOM Biotech
    B.1.3.4CountrySpain
    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 supportSOM Biotech
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSOM Biotech
    B.5.2Functional name of contact pointClinical Operations Manager
    B.5.3 Address:
    B.5.3.1Street AddressBaldiri Reixac, 4
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08028
    B.5.3.4CountrySpain
    B.5.4Telephone number34934020150
    B.5.6E-mailesteva@sombiotech.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 Yes
    D.2.1.1.1Trade name Calvan® 100 mg
    D.2.1.1.2Name of the Marketing Authorisation holderNippon Chemiphar
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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.3.4Pharmaceutical form 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 INNBEVANTOLOL HYDROCHLORIDE
    D.3.9.1CAS number 42864-78-8
    D.3.9.2Current sponsor codeSOM3355
    D.3.9.4EV Substance CodeSUB00793MIG
    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 placeboCapsule
    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
    Chorea movements associated with Huntington's Disease
    Movimientos coreicos asociados a enfermedad de Huntington
    E.1.1.1Medical condition in easily understood language
    Chorea movements associated with Huntington's Disease
    Movimientos coreicos asociados a enfermedad de Huntington
    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 LLT
    E.1.2Classification code 10020469
    E.1.2Term Huntington's chorea
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine wheter SOM3355 reduces chorea movements associated with Huntington's Disease.
    Determinar si SOM3355 reduce los movimientos coreicos asociados a enfermedad de Huntington
    E.2.2Secondary objectives of the trial
    - Improvement based on Clinical Global Impression of Change (CGIC), on Patient Global Impression of Change (PGIC) as well as Total Functional Capacity (TFC), Functional Assessment, Gait Score and Total Motor Score (TMS) of the Unified Huntington's Disease Rating Scale (UHDRS).
    - Suicide severity assessment based on Columbia’s Suicide Severity Rating Scale (C-SSRS).
    - Safety when the drug is administered to HD patients, with special attention to blood pressure (BP) and cardiac function.
    - Mejoría basada en las escalas de Impresión Global de Cambio Clínica (CGIC) e Impresión Global de Cambio del Paciente (PGIC), así como en la Capacidad Funcional Total (TFC), Evaluación Funcional, Puntuación de la marcha y Puntuación Motora Total (TMS) de la Escala de Evaluación Unificada de la Enfermedad de Huntington (UHDRS).
    - Evaluación de la gravedad del suicidio basada en la Escala de Clasificación de la Severidad del Suicidio de Columbia (C-SSRS).
    - Seguridad cuando el fármaco se administra a pacientes con EH, con atención especial a la presión sanguínea y la función cardiaca.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subject is at least 18 years of age at time of consent.
    - Diagnosis of HD definite by a movement disorders expert confirmed by a number of HTT gene CAG repeats equal or greater than 36.
    - Female of child bearing potential and non-vasectomized male agree to practice appropriate methods of birth control.
    - Ability to walk independently or with minimal assistance.
    - UHDRS TMC Score equal or greater than 8.
    - UHDRS TFC equal or greater than 4.
    - Subject has provided written informed consent or through his/her legally authorized representative.
    - Tener al menos 18 años de edad en el momento del consentimiento.
    - Diagnóstico de la Enfermedad de Huntington (EH) definido por un experto en transtornos del movimiento y confirmado por un número de repeticiones CAG del gen HTT igual o superior a 36.
    - Las mujeres potencialmente fértiles y los hombres no vasectomizados aceptan utilizar métodos anticonceptivos apropiados.
    - Capacidad de caminar de forma independiente o con asistencia mínima.
    - Puntuación de Corea Total Máxima (TMC) de la Escala de Evaluación Unificada de la Enfermedad de Huntington (UHDRS) igual o superior a 8.
    - Capacidad Funcional Total (TFC) de la UHDRS igual o superior a 4.
    - El sujeto ha proporcionado su consentimiento informado (CI) por escrito o por medio de su representante legal autorizado.
    E.4Principal exclusion criteria
    - Onset of HD symptoms prior to age 18 (Juvenile forms of HD).
    - Non-ambulatory patients.
    - A past medical history of clinically significant electrocardiogram (ECG) abnormalities or a family history (grandparents, parents and siblings) of a prolonged QT-interval syndrome.
    - Pregnant or breastfeeding female patients, including those planning to conceive during the period of the trial.
    - Patients with psychiatric symptoms, or other impairments, that would interfere with their full compliance with the Investigator instructions and testing, unless there is an identified caregiver to support the patient.
    - Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study. The Investigator should make this determination in consideration of the subject’s medical history and/or clinical laboratory test results at screening and baseline.
    - Known allergy/sensitivity/intolerance to the study drugs or their excipients.
    - Any significant laboratory results which, in the Investigator’s opinion, would not be compatible with study participation or represent a risk for the subject while in the study.
    - Prescribed anti-hypertensive medication, tetrabenazine, deutetrabenazine or valbenazine within 15 days prior starting the investigational treatment.
    - Excluded concomitant medications: Any Anti-hypertensive medication; Tetrabenazine, deutetrabenazine or valbenazine; All typical neuroleptics; All MAO inhibitors.
    - Subject has a history of alcohol or substance abuse in the previous 12 months.
    - Patients with diabetic ketoacidosis or metabolic acidosis.
    - Patients with cardiogenic shock, congestive heart failure, pulmonary hypertension due to right-sided heart failure, severe sinus bradycardia, atrioventricular block (grades II and III) or sinoatrial block.
    - Subject has participated in an investigational drug or device trial within 30 days prior starting the investigational treatment.
    - Inicio de los síntomas de la enfermedad de Huntington antes de los 18 años (formas juveniles de EH).
    - Pacientes no ambulatorios.
    - Antecedentes clínicos de anomalías del electrocardiograma (ECG) clínicamente significativas o antecedentes familiares (abuelos, padres y hermanos) de síndrome de intervalo QT prolongado.
    - Mujeres embarazadas o lactantes, incluyendo aquellas que planean concebir durante el período del ensayo.
    - Pacientes con síntomas psiquiátricos u otros impedimentos que interfieran con su total cumplimientos de las instrucciones y pruebas del investigador, a menos que el paciente disponga de un cuidador identificado que le pueda ayudar.
    - Cualquier condición quirúrgica o médica que pueda alterar significativamente la absorción, distribución, metabolismo o excreción de fármacos, o que pueda poner en peligro al sujeto en caso de participar en el estudio. Para esto, el investigador deberá tener en cuenta el historial médico del sujeto y/o los resultados de las pruebas de laboratorio clínico realizadas durante el proceso de selección del sujeto a incluir.
    - Alergia, sensibilidad o intolerancia conocida al fármaco de estudio o a sus excipientes.
    -Cualquier resultado de laboratorio significativo que, a juicio del investigador, no sea compatible con la participación en el estudio o represente un riesgo para el sujeto durante el estudio.
    - Medicamento antihipertensivo, tetrabenazina, deutetrabenazina o valbenazina prescritos dentro de los 15 días previos al inicio del tratamiento de investigación.
    - Medicamentos concomitantes excluidos: Cualquier medicamento antihipertensivo; Tetrabenazina, deutetrabenazina o valbenazina; Todos los neurolépticos típicos; Todos los inhibidores de monoamino oxidasas (MAO).
    - Sujeto con antecedentes de abuso de alcohol o sustancias en los últimos 12 meses.
    - Pacientes con cetoacidosis diabética o acidosis metabólica.
    - Pacientes con shock cardiogénico, insuficiencia cardiaca congestiva, hipertensión pulmonar por insuficiencia cardiaca derecha, bradicardia sinusal severa, bloqueo auriculoventricular (grados II y III) o bloqueo sinoauricular.
    - El sujeto ha participado en un ensayo de cualquier fármaco o dispositivo en investigación dentro de los 30 días previos al inicio del tratamiento de investigación.
    E.5 End points
    E.5.1Primary end point(s)
    Improvement in any active drug period in TMC Score of at least 2 points compared with placebo period.
    Mejoría en cualquier período de fármaco activo en la puntuación de la Corea Total Máxima (TMC) de al menos 2 puntos en comparación con el período de placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of study treatment.
    Al final del tratamiento del estudio.
    E.5.2Secondary end point(s)
    - Clinical Global Impression of Change (CGIC) scale.
    - Patient Global Impression of Change (PGIC) scale.
    - Total Functional Capacity (TFC) of the UHDRS.
    - Functional Assessment of the UHDRS.
    - Gait score of the UHDRS.
    - Total Motor Score (TMS) of the UHDRS.
    - Columbia Suicide Severity Rating Scale (C-SSRS)
    - Safety: The maximum grade for each type of adverse event (AE) will be recorded for each subject, and frequency tables will be presented and reviewed to determine patterns. Additionally, the relationship of the AE to the study treatment will be taken into consideration. The frequency of AE as hypotension and cardiovascular events will be specifically analyzed.
    - Escala de Impresión Global de Cambio Clínica (CGIC)
    - Escala de Impresión Global de Cambio del Paciente (PGIC)
    - Capacidad Funcional Total (TFC) de la UHDRS
    - Evaluación Funcional de la UHDRS
    - Puntuación de la marcha de la UHDRS
    - Puntuación Motora Total (TMS) de la UHDRS
    - Escala de Clasificación de Severidad del Suicidio de Columbia (C-SSRR)
    - Seguridad: Se registrará para cada sujeto el grado máximo de cada tipo de acontecimiento adverso (AA), y se presentarán y revisarán las tablas de frecuencia para determinar los patrones. Además, se tendrá en cuenta la relación de los AA con el tratamiento de estudio, y se analizarán especificamente la frecuencia de AA como hipotensión y efectos cardiovasculares
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the study.
    Al final del estudio.
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Escalada de dosis
    Dose scaling
    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 concerned4
    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
    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 years
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months9
    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: 30
    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 state30
    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 Decision2018-06-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-08-22
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