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    Summary
    EudraCT Number:2017-002838-23
    Sponsor's Protocol Code Number:CL02-ORY-2001MS
    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:2017-07-21
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2017-002838-23
    A.3Full title of the trial
    Randomized, double-blind, placebo-controlled, 3-arm, 36 weeks parallel-group study to evaluate the safety and tolerability of ORY-2001 in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) and Secondary Progressive Multiple Sclerosis (SPMS)
    Estudio aleatorizado, doble ciego, controlado con placebo, de grupos paralelos, con 3 grupos y de 36 semanas de duración, para evaluar la seguridad y la tolerabilidad de ORY-2001 en pacientes con esclerosis múltiple remitente-recurrente (EMRR) y esclerosis múltiple secundaria progresiva (EMSP).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized, double-blind, placebo-controlled, 3-arm, 36 weeks parallel-group study to evaluate the safety and tolerability of ORY-2001 in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) and Secondary Progressive Multiple Sclerosis (SPMS)
    Estudio aleatorizado, doble ciego, controlado con placebo, de grupos paralelos, con 3 grupos y de 36 semanas de duración, para evaluar la seguridad y la tolerabilidad de ORY-2001 en pacientes con esclerosis múltiple remitente-recurrente (EMRR) y esclerosis múltiple secundaria progresiva (EMSP).
    A.4.1Sponsor's protocol code numberCL02-ORY-2001MS
    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 SponsorOryzon Genomics S. A
    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 supportOryzon Genomics S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTrial Form Support
    B.5.2Functional name of contact pointLaia Torruella
    B.5.3 Address:
    B.5.3.1Street AddressConsell de cent 334
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08009
    B.5.3.4CountrySpain
    B.5.4Telephone number0034931850200
    B.5.6E-maillaia.torruella@tfscro.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameORY2001
    D.3.2Product code ORY2001
    D.3.4Pharmaceutical form Capsule
    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 yet requested
    D.3.9.2Current sponsor codeORY2001
    D.3.9.3Other descriptive namePHENYLCYCLOPROPYLAMINE DERIVATIVES AND DUAL LSD1/MAO-B (LYSINE-SPECIFIC DEMETHYLASE 1 AND MONOAMINE OXIDASE-B) INHIBITOR
    D.3.9.4EV Substance CodeSUB179357
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.6 to 1.2
    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
    patients with Relapsing-Remitting Multiple Sclerosis (RRMS) and Secondary Progressive Multiple Sclerosis (SPMS)
    pacientes con esclerosis múltiple remitente-recurrente (EMRR) y esclerosis múltiple secundaria progresiva (EMSP).
    E.1.1.1Medical condition in easily understood language
    patients with Relapsing-Remitting Multiple Sclerosis (RRMS) and Secondary Progressive Multiple Sclerosis (SPMS)
    pacientes con esclerosis múltiple remitente-recurrente (EMRR) y esclerosis múltiple secundaria progresiva (EMSP).
    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 10063400
    E.1.2Term Secondary progressive multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple 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 evaluate the safety and tolerability of two doses of ORY-2001 compared to placebo in multiple sclerosis (MS) subjects.
    Evaluar la seguridad y tolerabilidad de dos dosis de ORY-2001 en comparación con placebo en pacientes con esclerosis múltiple (EM)
    E.2.2Secondary objectives of the trial
    To assess the effect of two doses of ORY-2001 on inflammatory Magnetic Resonance Imaging (MRI) measures compared to placebo in MS subjects.
    Evaluar el efecto de dos dosis de ORY-2001 sobre el nivel de inflamación determinado mediante resonancia magnética (RM) en comparación con placebo en pacientes con EM.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients aged 18-65 years, inclusive
    2. Diagnosis of MS (McDonald Criteria 2010)
    3. Relapsing-Remitting or Secondary Progressive MS phenotypes
    4. Active MS within the previous 12 months, defined as:
    a. At least one relapse, or
    b. At least one T1 Gadolinium (Gd)-enhancing lesion*, or
    c. At least one new or enlarging T2 lesion*
    * Subjects without evidence of active MS in the last 12 months can be included if at least one of these two criteria are fulfilled at the screening MRI performed up to 7 days prior to randomization
    5. Expanded Disability Status Scale (EDSS) at screening and baseline visit between 0 and 6.5
    6. Fertile male and female must use highly efficient contraception from Screening visit until the last treatment day (including open-label period), defined as:
    i. A method with less than 1% failure rate (e.g. permanent sterilisation, hormone implants, hormone injections, some intrauterine devices, or vasectomised partner)
    OR
    ii. The use of two methods of contraception (e.g. one barrier method [condom, diaphragm or cervical/vault caps] with spermicide and one hormonal contraceptive [e.g. combined oral contraceptives, patch, vaginal ring, injectables and implants])
    7. Patient must sign and date a written informed consent prior to entering the study
    1. Pacientes de entre 18 y 65 años, inclusive.
    2. Diagnóstico de EM (según los criterios de McDonald de 2010).
    3. Fenotipo de EM remitente-recurrente o secundaria progresiva.
    4. EM activa en los últimos 12 meses, definida como:
    a. Como mínimo una recidiva, o
    b. Como mínimo una lesión con captación de gadolinio (Gd) en T1,* o
    c. Como mínimo una lesión nueva o con aumento de tamaño en T2.*
    * Puede incluirse a pacientes sin indicios de EM activa en los últimos 12 meses si cumplen por lo menos uno de estos dos criterios en la RM de la selección, realizada hasta 7 días antes de la aleatorización.
    5. Puntuación en la Escala ampliada del estado de discapacidad (EDSS) en la selección y la visita inicial entre 0 y 6,5.
    6. Los hombres y las mujeres fértiles deberán usar métodos anticonceptivos con una eficacia elevada desde la visita de selección hasta el último día del tratamiento (incluido el período abierto), definidos como:
    i. Un método con menos de un 1 % de tasa de ineficacia (p. ej., esterilización permanente, implantes hormonales, inyecciones hormonales, algunos dispositivos intrauterinos o pareja sometida a vasectomía).
    O BIEN
    ii. El uso de dos métodos anticonceptivos (p. ej., un método de barrera [preservativo, diafragma o capuchón cervical] con espermicida y un anticonceptivo hormonal [p. ej., anticonceptivos orales combinados, parche, anillo vaginal, inyectables o implantes]).
    7. Los pacientes deben firmar y fechar un consentimiento informado por escrito antes de la inclusión en el estudio
    E.4Principal exclusion criteria
    1. Previous history of central nervous system (CNS) or psychiatric clinical disease that according to the investigator might confound the assessment of the study endpoints
    2. CNS or psychiatric current therapies specifically anti-depressants as tranylcypromine or phenelzine and Monoamine Oxidase (MAO) therapies
    3. Cancer history or cancer therapies that according to the investigator might confound the assessment of the study endpoints
    4. Patients with uncontrolled hypertension (uncontrolled in the opinion of the investigator), and diabetes (consistent glucose level >100 mg/dL) or hepatitis (persistent liver inflammation)
    5. Inter-current illness or social situation that will limit compliance with study requirements
    6. MS relapse in the 6 weeks prior to randomization
    7. Treatment with any investigational medicinal product within twelve weeks prior to randomization or 5 half-lives, whichever is longer
    8. Treatment with interferon beta or glatiramer acetate in the four weeks prior to randomization
    9. Treatment with fingolimod or dimethyl fumarate in the twelve weeks prior to randomization
    10. Treatment with azathioprine or methotrexate in the 6 months prior to randomization
    11. Treatment with teriflunomide in the previous year unless a successful wash-out procedure has been performed (plasmatic levels below 0.02 mg/l) prior to randomization
    12. Treatment with natalizumab, alemtuzumab, ocrelizumab, rituximab, ofatumumab, cladribine, mitoxantrone or cyclophosphamide in the year prior to randomization
    13. Concomitant treatment with known MAO inhibitors (as rasagiline) or with other drugs with known incompatibility with MAO inhibitors or contraindications to receive MAO inhibitors
    14. A known history of hypersensitivity to Gd
    15. Participation in another clinical trial with an investigational drug product not completed within the 30 days prior to enrolment
    16. Abnormal or clinically relevant haematology and biochemistry laboratory tests values (including kidney function profile)
    17. Abnormal clinical evaluation
    18. Abnormal or clinically relevant electrocardiogram (ECG) findings
    19. Positive tuberculosis, human immunodeficiency virus (HIV), hepatitis C or hepatitis B (Hepatitis B surface antigen [HbsAg]) serology (test performed at screening)
    20. Pregnancy or breast feeding
    21. History of alcohol or substance abuse
    1. Antecedentes de enfermedad del sistema nervioso central (SNC) o de enfermedad psiquiátrica clínica que, según el criterio del investigador, puedan constituir un factor de confusión en la evaluación de los criterios de valoración del estudio.
    2. Tratamiento psiquiátrico o del SNC actual, específicamente antidepresivos como la tranilcipromina o la fenelzina, y tratamientos dirigidos a la monoaminooxidasa (MAO).
    3. Antecedentes de cáncer o tratamientos antineoplásicos que, según el criterio del investigador, puedan constituir un factor de confusión en la evaluación de los criterios de valoración del estudio.
    4. Hipertensión no controlada (según el criterio del investigador) y diabetes (nivel de glucosa >100 mg/dl de forma constante) o hepatitis (inflamación hepática persistente).
    5. Enfermedad intercurrente o situación social que limite el cumplimiento de los requisitos del estudio.
    6. Recidiva de la EM en las 6 semanas previas a la aleatorización.
    7. Tratamiento con cualquier medicamento en investigación en las 12 semanas, o 5 semividas, previas a la aleatorización, lo que sea más largo.
    8. Tratamiento con interferón beta o acetato de glatirámero en las 4 semanas previas a la aleatorización.
    9. Tratamiento con fingolimod o dimetilfumarato en las 12 semanas previas a la aleatorización.
    10. Tratamiento con azatioprina o metotrexato en los 6 meses previos a la aleatorización.
    11. Tratamiento con teriflunomida en el año anterior, a menos que se haya realizado un procedimiento de lavado farmacológico adecuado antes de la aleatorización (niveles plasmáticos inferiores a 0,02 mg/l).
    12. Tratamiento con natalizumab, alemtuzumab, ocrelizumab, rituximab, ofatumumab, cladribina, mitoxantrona o ciclofosfamida en el año previo a la aleatorización.
    13. Tratamiento concomitante con inhibidores conocidos de la MAO (como la rasagilina) o con otros fármacos con incompatibilidad conocida con los inhibidores de la MAO, o pacientes en los que los inhibidores de la MAO estén contraindicados.
    14. Antecedentes conocidos de hipersensibilidad al Gd.
    15. Participación en otro ensayo clínico con un medicamento en investigación que no haya concluido en los 30 días previos a la inclusión.
    16. Valores anómalos o clínicamente relevantes en los valores analíticos de hematología y bioquímica (incluido el perfil de la función renal).
    17. Evaluación clínica anómala.
    18. Hallazgos anómalos o clínicamente relevantes en el electrocardiograma (ECG).
    19. Serología positiva para la tuberculosis, el virus de la inmunodeficiencia humana (VIH) o la hepatitis C o B (antígeno de superficie de la hepatitis B: HbsAg). Prueba realizada durante la selección.
    20. Embarazo o lactancia.
    21. Antecedentes de abuso de alcohol o drogas.
    E.5 End points
    E.5.1Primary end point(s)
    • Number, frequency and severity of Adverse Events (AEs).
    • Number, frequency and severity of Serious Adverse Events (SAEs)
    • Number and percentage of withdrawn patients due to AEs
    • Change from baseline in physical examination, vital signs and ECG parameters
    • Frequency of physical examination parameters, vital signs and ECG parameters of potential clinical concern
    • Change from baseline in clinical laboratory parameters (hematology, clinical chemistry and urinalysis)
    • Frequency of clinical laboratory parameters (hematology, clinical chemistry and urinalysis) of potential clinical concern
    • Use of concomitant medication
    • Número, frecuencia e intensidad de los acontecimientos adversos (AA).
    • Número, frecuencia e intensidad de los acontecimientos adversos graves (AAG).
    • Número y porcentaje de pacientes que se retiran a causa de los AA.
    • Cambios en la exploración física, las constantes vitales y los parámetros del ECG respecto al estado inicial.
    • Frecuencia con que se observan parámetros de la exploración física, constantes vitales o parámetros del ECG que puedan suponer un problema desde el punto de vista clínico.
    • Cambios en los parámetros analíticos (hematología, bioquímica clínica y análisis de orina) respecto a los valores iniciales.
    • Frecuencia con que se observan parámetros analíticos (hematología, bioquímica clínica y análisis de orina) que puedan suponer un problema desde el punto de vista clínico.
    • Uso de medicación concomitante.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End points will be evaluated at the end of study vs the baseline values.
    Los end points del estudio serán evaluados al final del mismo comparándolos con los valores de la visita basal
    E.5.2Secondary end point(s)
    • Cumulative number of Combined Unique Active lesions (CUAL) (defined as Gd-enhancing T1-weighted lesions and non-enhancing new/enlarging T2-weighted lesions) at weeks 8, 12, 24, 32 and 36 as assessed through MRI.
    • Número acumulado de lesiones activas combinadas únicas (CUAL, por sus siglas en inglés; definidas como lesiones que captan Gd en la imagen ponderada en T1, o lesiones nuevas o con aumento de tamaño que no captan Gd en la imagen ponderada en T2) en las semanas 8, 12, 24, 32 y 36, evaluadas mediante RM
    E.5.2.1Timepoint(s) of evaluation of this end point
    at weeks 8, 12, 24, 32 and 36
    A la semana 8, 12, 24, 32 y 36
    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 No
    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
    Tolerability
    Tolerabilidad
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State 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 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 study is defined as the date of the last subject’s last visit (EoS visit for the last subject included).
    El final del estudio se define como la fecha de la última visita del último paciente (última visita del estudio para el último paciente incluido)
    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: 24
    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 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 state24
    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)
    For the open label extension phase under treatment, patients who were originally randomised to ORY-2001 will continue their assigned treatment and those receiving the placebo will be re-allocated to ORY-2001, 0.6 mg fiw or 1.2 mg fiw, according to the predefined randomisation schedule
    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 Decision2017-10-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-25
    P. End of Trial
    P.End of Trial StatusOngoing
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