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    Summary
    EudraCT Number:2007-005054-23
    Sponsor's Protocol Code Number:V00251 IV 201
    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:2008-02-29
    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 number2007-005054-23
    A.3Full title of the trial
    Estudio doble ciego, controlado con placebo sobre la eficacia y tolerancia de V0251 1g, 2g y 4g en neuritis vestibular

    A double-blind placebo controlled study of 1g, 2g and 4g V0251 efficacy and tolerance in vestibular neuritis.
    A.4.1Sponsor's protocol code numberV00251 IV 201
    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 SponsorPIERRE FABRE MEDICAMENT - IRPF
    B.1.3.4CountryFrance
    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.4.2Country
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameL-acetil leucina
    D.3.2Product code V0251
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNL-acetil leucina
    D.3.9.1CAS number 1188-21-2
    D.3.9.2Current sponsor codeV0251
    D.3.9.3Other descriptive nameacido 2(S)-(acetilamino)-4-metilpentanoico
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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.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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    EL V0251 es un nuevo agente anivértigo que ha sido desarrollado para el tratamiento sintomático de las cirisis de vértigo.

    V0251 is a new investigational antivertiginous agent which is being developed for the treatment of symptomatic vertiginous crisis.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10047340
    E.1.2Term Vertigo
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determinar la eficacia en la compensación vestibular central de 3 dosis de L-acetil leucina frente a placebo en 4 días de administración intravenosa en pacientes hospitalizados por neuritis vestibular aguda
    E.2.2Secondary objectives of the trial
    - Determinar la duración del tratamiento
    - Evaluar una relación dosis-efecto
    - Determinar la tolerancia de 3 dosis de L-acetil leucina en 4 días de administración intravenosa en pacientes hospitalizados por neuritis vestibular.
    - Determinar la dosis óptima (eficacia y tolerancia) de L-acetil leucina en 4 días de administración intravenosa en pacientes hospitalizados por neuritis vestibular.
    - Evaluar los criterios principales y las elecciones de los criterios de valoración
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Serán adecuados para participar en el estudio los candidatos que cumplan con los siguientes criterios:

    - Paciente mayor de 18 años,
    - Paciente ingresado en el hospital por vértigo relacionado con neuritis vestibular aguda,
    - Neuritis vestibular (vestibulopatía unilateral aguda) definida como:
    • aparición aguda o subaguda grave y prolongado de vértigo rotatorio, náuseas, desequilibrio postural que comenzó menos de 48h antes de la visita de inclusión,

    • nistagmo espontáneo horizontal-rotatorio batiendo hacia el oído no afectado (fase rápida), sin evidencia de lesión vestibular central,

    • velocidad de la fase lenta durante la irrigación calórica con agua templada a 30ºC y agua caliente a 44ºC inferior a tres grados por segundo en el lado afectado para cada irrigación; con una asimetría entre los dos lados de más del 25 por ciento según la fórmula de Jongkees durante la prueba calórica bitermal que se realizará 3 días después del tratamiento (iniciado en la visita de inclusión),

    - Prueba de embarazo negativa en la inclusión para las mujeres en edad fértil y utilización de un anticonceptivo eficaz (anticonceptivos mediante implantes, inyectables, combinados orales, algunos dispositivos intrauterinos, abstinencia sexual o pareja con vasectomía relacionado con la nota 3 del CPMP/ICH/286/95, véase el apéndice) durante al menos 2 meses antes del estudio y un mes después de la finalización del mismo.
    - Paciente que acepta participar en el estudio y es capaz de comprender y firmar un formulario de consentimiento informado aprobado,
    - Paciente capaz de comprender el protocolo y de asistir a las visitas de control,
    - Paciente que, según el criterio del investigador, es probable que cumpla con los requisitos durante el estudio
    - Si es necesario según la normativa nacional, paciente registrado en un sistema de seguridad social o seguro de salud
    E.4Principal exclusion criteria
    * Criterios relacionados con patologías

    - Disfunción vestibular antes de la aparición aguda de los síntomas,
    - Acúfenos unilaterales (el mismo lado que el oído afectado) durante o después de la aparición del vértigo,
    - Hipoacusia aguda durante o después de la aparición del vértigo,
    - Disfunción oculomotora central
    - Disfunción vestibular central
    - Síntomas de trastorno cerebeloso
    - Síntomas de trastorno neurológico central
    - Antecedentes o síntomas de migraña vestibular
    - Antecedentes recientes de traumatismo craneal y/o otológico,
    - Perforación de la membrana timpánica
    - Otitis media crónica,

    * Criterios relacionados con tratamientos

    - Pacientes con antecedentes de hipersensibilidad a la acetil leucina o a los excipientes,
    - Antecedentes de administración sistémica o transtimpánica de aminoglucósidos o de cualquier otra sustancia ototóxica,
    - Más de una administración oral o intravenosa de medicamentos antivertiginosos antes de la visita de inclusión,
    - Ingesta de somníferos, antidepresivos, si se inició o se modificó la indicación médica en los 3 meses anteriores a la visita de inclusión,

    * Criterios relacionados con la población

    - Antecedentes médicos de enfermedad médica o psiquiátrica grave que, según el criterio del investigador, los pongan en riesgo o sea probable que modifiquen su manejo del medicamento del estudio,
    - Mujer embarazada o lactante o que no utilice anticonceptivos, o que esté planeando quedarse embarazada,
    - Participación en otro ensayo clínico en el mes anterior o durante el estudio,
    - Paciente que no sea capaz de comprender la información (por motivos lingüísticos o psiquiátricos) y de dar el consentimiento informado,
    - Paciente que, según el criterio del investigador, es probable que no cumpla con los requisitos durante el estudio,
    - Paciente que tenga penalizada su libertad por decisión legal o administrativa o que esté bajo tutela.
    E.5 End points
    E.5.1Primary end point(s)
    Pico de velocidad ocular de la fase lenta del nistagmo espontáneo horizontal (en º/s) el D4.
    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 No
    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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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.8.3 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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 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
    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 months17
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months17
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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 Decision2008-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-08-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-04-19
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