Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43850   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2007-004988-22
    Sponsor's Protocol Code Number:ACR16 C008
    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:2008-02-11
    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 number2007-004988-22
    A.3Full title of the trial
    Un estudio multicentro, internacional, aleatorizado, doble ciego y de grupos paralelos que compara la administración de ACR16 45 mg una o dos veces al día frente al placebo, para el tratamiento sintomático de la Enfermedad de Huntington.

    (A multicentre, multinational, randomised, double-blind, parallel-group study comparing ACR16 45mg once-daily or twice-daily versus placebo for the symptomatic treatment of Huntington’s Disease)
    A.3.2Name or abbreviated title of the trial where available
    A Study of Treatment with ACR16 in Patients with Huntington's Disease (ACR16 C008)
    A.4.1Sponsor's protocol code numberACR16 C008
    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 SponsorNeuroSearch Sweden AB
    B.1.3.4CountrySweden
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/05/288
    D.3 Description of the IMP
    D.3.1Product nameACR16
    D.3.2Product code ACR16
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.2Current sponsor codeACR16
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number45
    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 placeboCapsule, hard
    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
    Enfermedad de Huntington (Huntington's Disease)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10020469
    E.1.2Term Huntington's chorea
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal consiste en evaluar los efectos del ACR16 sobre los movimientos voluntarios en pacientes que padecen la HD, definidos como la puntuación total de los elementos 4-10 y 13-15 de la evaluación motora de la UHDRS (una puntuación motora modificada -mMs) a las 26 semanas de tratamiento.
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios consisten en evaluar los efectos del ACR16 sobre lo siguiente:
    • Evaluación de la mejora global conforme a la CGI en la Semana 26
    • Cambio en la prueba de lectura de Stroop desde la visita de referencia hasta la Semana 26
    • Cambio en la evaluación conductual conforme a la UHDRS total desde la visita de referencia hasta la Semana 26
    • Cambio en la HADS total desde la visita de referencia hasta la Semana 26
    • Seguridad y tolerabilidad valorada a partir del perfil de eventos adversos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Capacidad para facilitar un consentimiento informado escrito, antes de cualquier procedimiento relacionado con el estudio.

    Enfermedad de Huntington diagnosticada con ayuda de características clínicas y un historial familiar positivo y/o la presencia de ≥ 36 repeticiones CAG en el gen de Huntington.

    Hombre o mujer de ≥ 30 años.

    Voluntad y capacidad para tomar medicación oral y cumplir los procedimientos específicos del estudio.

    Ambulatorio, con capacidad para desplazarse al centro de evaluación y que el Investigador determine que probablemente podrá continuar desplazándose mientras dure el estudio.

    Disponibilidad de un cuidador o familiar que pueda acompañar al paciente en las Visitas 1 y 7.

    Una suma de ≥ 10 puntos en la mMS, en la visita de evaluación.

    En el caso de los pacientes que utilicen una medicación antipsicótica permitida, la dosis de la medicación deberá haberse mantenido constante durante al menos 6 semanas antes de la Visita 1 (visita de aleatorización). La medicación antipsicótica permitida es amisulprida, haloperidol, olanzapina, risperidona, sulpirida o tiaprida.

    En el caso de los pacientes que utilicen una medicación antidepresiva u otra medicación psicotrópica permitida, la dosis de la medicación deberá haberse mantenido constante durante al menos 6 semanas antes de la Visita 1 (visita de aleatorización).

    Voluntad de facilitar una muestra de sangre para el análisis CAG (cuando el resultado CAG todavía no esté disponible).
    E.4Principal exclusion criteria
    Incapacidad para facilitar el consentimiento informado escrito.

    Tratamiento con alguna medicación antipsicótica no permitida durante las 12 semanas anteriores a la Visita 1 (visita de aleatorización). La medicación antipsicótica no permitida es cualquier medicación que no sea amisulprida, haloperidol, olanzapina, risperidona, sulpirida o tiaprida.

    Tratamiento con los antidepresivos fluoxetina o paroxetina en las 6 semanas anteriores a la Visita 1 (visita de aleatorización).

    Uso de tetrabenacina en las 12 semanas anteriores a la Visita 1 (visita de aleatorización) o en cualquier momento durante el período del estudio.

    Tratamiento con algún producto en estudio durante las 4 semanas anteriores a la Visita 1 (visita de aleatorización).

    Uso de ajmalicina, quinidina o ritonavir durante las 6 semanas anteriores a la Visita 1 (visita de aleatorización).

    Pacientes anteriormente incluidos en este estudio.

    Un intervalo QTc prolongado en la visita de evaluación (definido como un intervalo QTc > 450 mseg. en el caso de los hombres o > 470 mseg. en las mujeres) u otros problemas cardíacos clínicamente significativos.

    Eliminación de creatinina <40mL/min medida en la visita de evaluación.*

    Cualquier resultado de laboratorio clínicamente significativo o anómalo en la visita de referencia, que, en opinión del Investigador, afecte a la idoneidad del paciente para el estudio o suponga un peligro para el paciente en caso de que participe en el estudio.

    Insuficiencia renal o hepática clínicamente significativa.

    Pacientes con un historial de epilepsia o de ataques de causa desconocida.

    Enfermedad recurrente grave, que, en opinión del Investigador, pueda suponer un peligro para el paciente si participa en el ensayo o pueda influir en los resultados del mismo o afectar a la capacidad del paciente para participar en el mismo.

    Consumo de alcohol y/o drogas, conforme a la definición de los criterios DSM IV-TR para el consumo de substancias –esto incluye el uso ilícito de cannabis en los 12 últimos meses.

    Pacientes con pensamientos suicidas, definidos por una puntuación positiva en el elemento A9 de los DSM IV-TR.

    Mujeres embarazadas o en período de lactancia.

    Las mujeres en edad fértil y que no empleen las medidas anticonceptivas adecuadas quedarán excluidas del ensayo. Las mujeres en edad fértil que tomen unas medidas anticonceptivas aceptables podrán ser incluidas .

    Alergia conocida a alguno de los ingredientes de la medicación del ensayo o del placebo (le rogamos consulte el Folleto del Investigador para obtener una lista completa de ingredientes).

    Cualquier participación previa en un estudio clínico con ACR16.

    *(Medición del Laboratorio Central utilizando la fórmula de Cockroft –Gault)
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal es el cambio en la mMS (elementos 4-10 y 13-15 de la evaluación motora de la UHDRS) desde la visita de referencia hasta la evaluación de la Semana 26.
    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 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) No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Last visit of last subject.
    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 days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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.1.3Elderly (>=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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-02-11. Yes
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 420
    F.4.2.2In the whole clinical trial 420
    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)
    Se realizará un estudio abierto de seguimiento de seguridad, de 6 meses de duración. Los pacientes que hayan completado este estudio podrán participar. Se presentará información más detallada acerca del estudio abierto de seguimiento en un protocolo separado.
    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 Decision2008-06-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-14
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 19 19:30:14 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA