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    EudraCT Number:2010-021179-10
    Sponsor's Protocol Code Number:TRO19622CLEQ1425-1
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-03-02
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2010-021179-10
    A.3Full title of the trial
    An Open Label Safety Extension Study of olesoxime (TRO19622) in Amyotrophic Lateral Sclerosis

    Un extensión del estudio en abierto de la seguridad del TRO19622 en Esclerosis Lateral Amiotrófica (ELA)
    de los pacientes tratados con riluzol.
    A.4.1Sponsor's protocol code numberTRO19622CLEQ1425-1
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTROPHOS SA
    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 support
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/06/397
    D.3 Description of the IMP
    D.3.1Product nameolesoxime
    D.3.2Product code TRO19622
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNolesoxime
    D.3.9.1CAS number 2203-87-0
    D.3.9.2Current sponsor codeTRO19622
    D.3.9.3Other descriptive name4 cholesten-3-one, oxime
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number165
    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) Information not present in EudraCT
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13
    E.1.2Level LLT
    E.1.2Classification code 10002026
    E.1.2Term Esclerosis lateral amiotrófica
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The principal aim of the study is to allow patients to be treated with olesoxime (TRO19622) in an Open Label safety Extension following their participation to a randomised study and to provide additional safety data on olesoxime (TRO 19622).
    This is a multicenter openlabel safety extension study of olesoxime in Amyotrophic Lateral sclerosis patients treated with riluzole.
    Each patient will be treated with olesoxime up to a maximum duration of 15 months. Permitir que los pacientes reciban tratamiento con olesoxima (TRO19622) en una fase abierta
    de extensión de seguridad después de su participación en un estudio aleatorizado y
    proporcionar datos adicionales de la seguridad de olesoxima (TRO19622).Se trata de un estudio multicéntrico, de diseño abierto, de ampliación de seguridad de olesoxima (TRO19622) en pacientes con esclerosis lateral amiotrófica (ELA) tratados con riluzola. Cada paciente recibirá tratamiento con olesoxima (TRO19622) durante 15 meses
    como máximo.
    E.2.2Secondary objectives of the trial
    Survival time / Tiempo de supervivencia
    Total score of the 48-point ALS Functional Rating Scale Revised /Puntuación total de la Escala de Evaluación Funcional de la ELA revisada de
    48 puntos
    Slow Vital capacity (SVC) as a percentage of predicted SVC only if the SVC is performed
    by the site in a routine-way during standard ALS visit. This test will not be performed for the sole purpose of the study / Capacidad vital lenta (CVL) como porcentaje de de la CVL teórica,
    únicamente si en el centro se realiza la CVL de forma habitual durante las visitas habituales de la ELA. Esta prueba no se realizará exclusivamente a
    efectos del estudio
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must have completed the 18month
    safety and efficacy study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole (Protocol TRO19622 CL E Q 10151).
    Both the investigator and the patient will decide based on previous good tolerance and other clinical grounds whether or not to participate to the openlabel extension. If patients were on antivitamin K during the doubleblind period, when entering the openlabel extension, coagulation
    tests should be monitored in exactly the same conditions as if a new anticoagulant treatment was initiated and the dose of antivitamin K should be adjusted accordingly(see secti on 8.3.11).
    Patients enrolling from this prior safety and efficacy study must:
    If female of childbearing age of potential, continue to use adequate birth control methods and have a negative serum pregnancy test at the preceding doubleblind protocol termination visit. Male and female partners must agree to use an
    effective method of birth control during their participation in the trial and for at least 15 days after the last IMP dose. Both partners must use reliable methods of contraception with 2 independent methods. The following measures are acceptable: Hormone contraceptives (e.g. oral contraceptives or comparable methods), intrauterine device, condoms with spermicidal coating or in combination with spermicidal creams, total abstinence or sterilisation performed in the
    past. Be able to follow the investigators instructions and be able to comply with the visit schedule and visit requirements;and Sign a written informed consent.
    · Los pacientes deben haber completado los 18 meses del estudio de eficacia y seguridad
    de TRO19622 en pacientes con esclerosis lateral amiotrófica (ELA) en tratamiento con
    riluzola (Protocolo TRO19622 CL E Q 1015-1).
    · El investigador y el paciente decidirán, basándose en la buena tolerancia previa y en
    otros fundamentos clínicos, su participación o no en el estudio de extensión abierto.
    · Si los pacientes estaban en tratamiento antivitamina K durante el periodo doble ciego,
    al entrar en la extensión abierta se deben supervisar las pruebas de coagulación
    exactamente en las mismas condiciones que si se iniciara un nuevo tratamiento
    anticoagulante, ajustándose la dosis de vitamina K en consecuencia (véase sección
    · Los pacientes incluidos procedentes de este estudio previo de seguridad y eficacia
    Si se trata de una mujer en edad fértil, continuar usando métodos adecuados de
    control de la natalidad y tener una prueba sérica de embarazo negativa en la visita
    de finalización del protocolo doble ciego,
    Ser capaces de seguir las instrucciones del investigador y poder cumplir el
    calendario de visitas y las exigencias de las visitas; y Firmar un consentimiento informado.
    E.4Principal exclusion criteria
    Patients may not participate to this study if they have an ongoing, unresolved, clinically significant medical problem (including patients having serious adverse events or nonserious,
    but medically significant adverse events during the preceding safety and efficacy study that was assessed to be related to the study medication by the investigator)that is on the judgment of the investigator would make it unsafe for the patient to participate in the trial.
    Los pacientes no pueden participar en este estudio si tienen un problema médico actual, no
    resuelto, clínicamente importante (incluidos los pacientes que han experimentado
    acontecimientos adversos graves o no graves, aunque médicamente significativos, durante el
    estudio precedente de seguridad y eficacia que el investigador juzgara relacionado con el
    medicamento del estudio) que, a criterio del investigador, hiciera arriesgada la participación
    del paciente en el ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure will be the safety assessment. The safety criteria will be: occurence of Adverse Events, Physical examination, Laboratory tests, vital signs and ECG.
    Variable principal de valoración: La variable principal de valoración será la evaluación de la
    seguridad. Los criterios de seguridad serán:
    · Aparición de AA
    · Exploración física,
    · Pruebas analíticas
    · Constantes vitales y ECG,
    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 Yes
    E.6.13.1Other scope of the trial description
    OPEN LABEL EXTENSION PHASE II/III (el estudio de extensión abierto fase II/III
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the study will be the last visit of the last subject. Patients must have completed 15 months visits.
    El final del estudio será la última visita del último sujeto. Los pacientes deben haber completado visitas de 15 meses.
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    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)
    already described in the protocol
    Ya descrito en el protocolo
    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 Decision2011-05-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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