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    The EU Clinical Trials Register currently displays   43845   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).

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    Summary
    EudraCT Number:2009-016041-25
    Sponsor's Protocol Code Number:RGH-MD-36
    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:2009-12-30
    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 number2009-016041-25
    A.3Full title of the trial
    A Long-Term Open-label Study of the Safety and Tolerability of Cariprazine in Patients With Bipolar I Disorder. Estudio abierto a largo plazo de la seguridad y la tolerabilidad de cariprazina en pacientes con trastorno bipolar tipo I.
    A.4.1Sponsor's protocol code numberRGH-MD-36
    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 SponsorForest Research Institute, Inc.
    B.1.3.4CountryUnited States
    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 nameCariprazina
    D.3.2Product code RGH-188
    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.3.9.2Current sponsor codeRGH-188
    D.3.9.3Other descriptive nameCariprazine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.5
    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.IMP: 2
    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 nameCariprazina
    D.3.2Product code RGH-188
    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.3.9.2Current sponsor codeRGH-188
    D.3.9.3Other descriptive nameCariprazine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Trastorno Bipolar Tipo I
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level PT
    E.1.2Classification code 10004939
    E.1.2Term Bipolar I disorder
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Estudio abierto a largo plazo de la seguridad y la tolerabilidad de cariprazina en pacientes con trastorno bipolar tipo I.
    E.2.2Secondary objectives of the trial
    "no hay objetivos secundarios"
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Criterios que habrán de evaluarse en la visita 1 (selección):
    1.Otorgamiento del consentimiento informado por escrito (firmado o con la impresión del pulgar) antes de iniciar ningún procedimiento específico del estudio.
    2.Varones o mujeres, de 18 a 65 años de edad, ambos inclusive.
    3.Cumplimiento actual de los criterios de trastorno bipolar tipo I según el DSM-IV-TR confirmado mediante la aplicación de la Entrevista clínica estructurada (SCID), episodio maníaco o mixto más reciente, con o sin síntomas psicóticos.
    4.Puntuación YMRS (Escala de valoración de la manía de Young) total &#8805; 18.
    5.Puntuación MADRS (Escala de valoración de la depresión de Montgomery-Asberg) < 18.
    6.Episodio maníaco o mixto que precisó tratamiento en los 12 meses anteriores a la visita 1.
    7.En las mujeres en edad fértil, una prueba de embarazo en suero (determinación de gonadotropina coriónica humana &#946; (&#946;-hCG)) negativa.
    8.Resultados normales de la exploración física, constantes vitales, pruebas analíticas y electrocardiograma (ECG) o resultados anómalos que el investigador considera que no tienen importancia clínica y que se documentan como tales en el CRDe.
    9.Índice de masa corporal (IMC) entre 18 y 40 kg/m2, ambos inclusive.
    Criterios que habrán de evaluarse en la visita 2 (basal):
    10.Continuación del cumplimiento de los criterios de inclusión de la visita 1.
    E.4Principal exclusion criteria
    1.Diagnóstico principal según el DSM-IV-TR de un trastorno del eje I, distinto de un trastorno bipolar tipo I, o cualquier trastorno del eje I distinto de un trastorno bipolar tipo I que fue el motivo principal del tratamiento en los 6 meses anteriores a la visita
    2.Cumplimiento actual de los criterios según el DSM-IV-TR de alguno de los procesos siguientes:
    •Retraso mental, delirium, demencia, amnesia u otros trastornos cognitivos.
    •Esquizofrenia, trastorno esquizoafectivo u otros trastornos psicóticos.
    •Ciclado rápido
    •Episodio maníaco o hipomaníaco provocado por sustancias psicoactivas. Manía que es resultado de los efectos psicológicos directos de una afección médica general.
    •Trastorno limítrofe o antisocial de la personalidad conocido o sospechado u otro trastorno del eje II según el DSM IV TR de intensidad suficiente para interferir en la participación en este estudio.
    3.Experimentación de un primer episodio maníaco.
    4.Riesgo inminente de autolesión, de lesionar a otros o de causar daños importantes a propiedades, según el criterio del investigador principal.
    5.Riesgo de suicidio, según lo determinado por alguno de los criterios siguientes:
    •Una tentativa de suicidio en el año precedente.
    •Una puntuación de 5 o más en el apartado 10 de la escala MADRS.
    •Riesgo significativo según el criterio del investigador principal basándose en la entrevista psiquiátrica o la información recopilada en la Escala (C-SSRS).
    6.Síntomas maníacos como consecuencia del inicio de un tratamiento antidepresivo previo.
    7.Tratamiento electroconvulsivo en los 3 meses anteriores a la visita 1.
    8.Tratamiento con un neuroléptico de liberación prolongada en los 3 meses anteriores a la visita 1.
    9.Tratamiento con clozapina en los 10 años precedentes (excepción: uso episódico de clozapina en dosis &#8804; 100 mg/día para tratar el insomnio).
    10.Resistencia previa al tratamiento electroconvulsivo.
    11.Mujeres que cumplan los criterios siguientes:
    •Embarazada, lactante o con previsión de quedarse embarazada o de amamantar durante el estudio.
    •Ausencia de un mínimo de 2 años de posmenopausia, de esterilidad quirúrgica (ligadura de trompas o histerectomía) o de la práctica de un método anticonceptivo fiable que se mantendrá durante todo el estudio.
    12.Toda afección médica coexistente que, a criterio del investigador principal, podría interferir en la realización del estudio, confundir la interpretación de los resultados del estudio o poner en peligro el bienestar de los pacientes.
    13.Toda enfermedad cardiovascular que tenga importancia clínica o se encuentre inestable o descompensada. Referirse a la sección 9.3.2., 16 del protocolo.
    14.Hipotiroidismo o hipertiroidismo, a menos que se encuentre estabilizado con la farmacoterapia adecuada y sin modificaciones de la posología durante al menos 3 meses antes de la visita 1.
    15.Concentración anómala de vitamina B12 o folato en el suero o síntomas psiquiátricos posiblemente secundarios a cualquier otra afección médica orgánica.
    16.Derivación gástrica o presencia de cualquier situación que quepa esperar que influya en la absorción del medicamento.
    17.Antecedentes de trastorno convulsivo, ictus, traumatismo craneoencefálico importante, tumor del sistema nervioso central o cualquier otra afección que predisponga al paciente a tener crisis comiciales.
    18.Infección conocida por el VIH.
    19.Diagnóstico reciente de hepatitis C durante el cribado de la visita 1 o antecedentes conocidos de infección por el virus de la hepatitis C a menos que se cumplan todos los criterios siguientes: el paciente no es candidato a recibir tratamiento antiviral, los anticuerpos totales contra el antígeno nuclear del virus de la hepatitis B no son reactivos y el investigador principal considera que la situación no interfiere en la participación del paciente en el estudio.
    20.Prueba positiva para el antígeno de superficie del virus de la hepatitis B o anticuerpos de tipo IgM contra el antígeno nuclear del virus de la hepatitis B.
    21.AST o ALT> 2 veces el límite superior de la normalidad (LSN), confirmada mediante repetición de la determinación.
    22.AST y/o ALT> 1,5 veces el LSN acompañada de un resultado positivo de IgM contra el VHA.
    23.Antecedentes de discinesia tardía (salvo casos leves atribuidos al uso de medicamentos convencionales), síndrome serotoninérgico o síndrome neuroléptico maligno.
    24.Pacientes que cumplan alguno de los criterios de evaluación del LOCS III según las sección del protocolo 9.3.2., 29.
    25.Tratamiento con cualquier PI, salvo cariprazina, en los 3 meses (o al menos 5 semividas, lo que sea más prolongado) anteriores a la visita 1.
    26.Incapacidad de hablar y entender el idioma local de forma suficiente para entender la naturaleza del estudio, otorgar el consentimiento informado por escrito (firmado o con la impresión del pulgar) y permitir la realización de todas las evaluaciones del estudio.
    27. Necesidad de tratamiento farmacológico para controlar los S
    E.5 End points
    E.5.1Primary end point(s)
    Recopilar información a largo plazo sobre la seguridad, incluyendo efectos secundarios, ECGs, parámetros de laboratorio y e información oftalmológica.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    El final del ensayo es la última visita del último paciente la cual incluye 3 semanas de seguimiento de seguridad.
    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) 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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 400
    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)
    Un período de seguimiento de la seguridad de 3 semanas. Antes de dar de baja del estudio a los pacientes, podrán someterse a un ajuste y estabilización con la medicación pertinente según lo considere necesario el investigador principal.
    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 Decision2010-03-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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    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.

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