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    Summary
    EudraCT Number:2012-003488-23
    Sponsor's Protocol Code Number:31-12-293
    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:2012-11-29
    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 number2012-003488-23
    A.3Full title of the trial
    A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Fixed-dose Once-daily Oral Aripiprazole in Children and Adolescents with Tourette?s Disorder
    Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo para evaluar la seguridad y la eficacia del aripiprazol administrado en dosis fijas por vía oral una vez al día en niños y adolescentes con síndrome de Gilles de la Tourette
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to test the safety and effectiveness of aripiprazole against placebo in children and adolescents with Tourette?s Disorder
    Ensayo clínico para evaluar la seguridad y eficacia del aripiprazol frente a placebo en niños y adolescentes con síndrome de Gilles de la Tourette
    A.4.1Sponsor's protocol code number31-12-293
    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 SponsorOtsuka Pharmaceutical Development & Commercialization, 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 supportOtsuka Pharmaceutical Development & Commercialization, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOtsuka Pharmaceutical Development & Commercialization, Inc.
    B.5.2Functional name of contact pointEva Kohegyi
    B.5.3 Address:
    B.5.3.1Street Address2440 Research Boulevard
    B.5.3.2Town/ cityRockville, Maryland
    B.5.3.3Post code20850
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 6095246790
    B.5.5Fax number+1 240 5143890
    B.5.6E-mailEva.Kohegyi@otsuka-us.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 Yes
    D.2.1.1.1Trade name Abilify
    D.2.1.1.2Name of the Marketing Authorisation holderOtsuka Pharmaceutical Europe
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameAripiprazole
    D.3.4Pharmaceutical form Tablet
    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 INNARIPIPRAZOLE
    D.3.9.1CAS number 129722-12-9
    D.3.9.4EV Substance CodeSUB05564MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.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 Yes
    D.2.1.1.1Trade name Abilify
    D.2.1.1.2Name of the Marketing Authorisation holderOtsuka Pharmaceutical Europe
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameAripiprazole
    D.3.4Pharmaceutical form Tablet
    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 INNARIPIPRAZOLE
    D.3.9.1CAS number 129722-12-9
    D.3.9.4EV Substance CodeSUB05564MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.IMP: 3
    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 Yes
    D.2.1.1.1Trade name Abilify
    D.2.1.1.2Name of the Marketing Authorisation holderOtsuka Pharmaceutical Commercialization & Development, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameAripiprazole
    D.3.4Pharmaceutical form Tablet
    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 INNARIPIPRAZOLE
    D.3.9.1CAS number 129722-12-9
    D.3.9.4EV Substance CodeSUB05564MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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.IMP: 4
    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 Yes
    D.2.1.1.1Trade name Abilify
    D.2.1.1.2Name of the Marketing Authorisation holderOtsuka Pharmaceutical Europe
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameAripiprazole
    D.3.4Pharmaceutical form Tablet
    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 INNARIPIPRAZOLE
    D.3.9.1CAS number 129722-12-9
    D.3.9.4EV Substance CodeSUB05564MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 placeboTablet
    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
    Tics associated with Tourette?s Disorder in children and adolescents
    Tics asociados al síndrome de Gilles de la Tourette en niños y
    adolescentes
    E.1.1.1Medical condition in easily understood language
    Sudden, repetitive and involuntary physical movements and vocal utterances associated with Tourette?s Disorder
    Movimientos físicos y expresiones vocales repentinos, repetitivos e involuntarios y asociados con el Desorden de Tourette
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10044126
    E.1.2Term Tourette's disorder
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic 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 compare the efficacy of aripiprazole with placebo in the suppression of tics in children and adolescents (7-17 years) with a diagnosis of Tourette's Disorder.
    Comparar la eficacia del aripiprazol con placebo para disminuir los tics en niños y adolescentes (7 a 17 años) con diagnóstico de síndrome de Gilles de la Tourette.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of aripiprazole once-daily treatment with oral tablets in children and adolescents with a diagnosis of Tourette's Disorder
    Evaluar la seguridad y la tolerabilidad del tratamiento oral con comprimidos de aripiprazol administrados una vez al día en niños y adolescentes con diagnóstico de síndrome de Gilles de la Tourette.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The subject is a male or female child or adolescent, 7-17 years of age (inclusive) at the time of signing the informed consent/assent.
    2. The subject meets current DSM-IV-TR diagnostic criteria for Tourette's Disorder, as confirmed by the K-SADS-PL, including the Diagnostic Supplement 5 (Substance Abuse and Other Diseases, ie, Tic Disorders).
    3. The subject has a TTS >= 20 on the YGTSS at Screening and Baseline (randomization).
    4. The subject, a caregiver, and the investigator must all agree that the presenting tic symptoms cause impairment in the subject's normal routines, which include academic achievement, occupational functioning, social activities, and/or relationships.
    5. Females of childbearing potential (defined by menarche and not having undergone surgical sterilization/hysterectomy) must have a negative pregnancy test, must be practicing acceptable double-barrier methods of contraception (or can confirm abstinence at each scheduled visit), and must not be pregnant or lactating.
    6. Written informed consent must be obtained from a legally acceptable representative (eg, guardian or caregiver), in accordance with local law and the requirements of the trial center?s institutional review board (IRB) or independent ethics committee (IEC), prior to the initiation of any protocol-required procedures. In addition, the subject, as required by the trial center?s IRB/IEC, must provide informed assent at Screening and as such must be able to understand that he or she can withdraw from the trial at any time.
    7. The subject and the designated guardian(s) or caregiver(s) are able to comprehend and satisfactorily comply with the protocol requirements, as evaluated by the investigator.
    1. El paciente es un niño o adolescente de sexo masculino o
    femenino, de 7 a 17 años de edad (inclusive) en el momento de firmar el consentimiento o asentimiento informado.
    2. El paciente debe reunir los criterios diagnósticos actuales del DSM-IV-TR de síndrome de G. de la Tourette, según se confirme mediante el cuestionario K-SADS-PL, incluido el suplemento Diagnostic Supplement 5 (Substance Abuse and Other Diseases, i.e., Tic Disorders).
    3. El paciente debe tener una puntuación total de tics (TTS, por sus siglas en inglés) >= 20 en la escala YGTSS en la selección y la visita inicial (aleatorización).
    4. El paciente, un cuidador designado y el investigador deben estar de acuerdo en que los síntomas de tics presentes causan un deterioro en las actividades normales del paciente, incluidos sus logros escolares, rendimiento laboral, actividades sociales y/o relaciones.
    5. Las mujeres con capacidad para procrear (según se define por
    la menarquia y no haber sido sometidas a esterilización quirúrgica/histerectomía) deben tener una prueba de embarazo negativa, usar métodos anticonceptivos aceptables de doble barrera (o poder confirmar la abstinencia sexual en todas las visitas programadas) y no quedar embarazadas ni amamantar.
    6. Se debe obtener el consentimiento informado por escrito de un representante legalmente aceptable (p. ej., tutor o cuidador), de conformidad con las leyes locales y los requisitos del Comité de Revisión Institucional (IRB, por sus siglas en inglés) o Comité Ético Independiente (CEI) del centro del estudio clínico, antes de iniciar cualquier procedimiento requerido por el protocolo. Además, el paciente, según lo requieran el IRB/CEI del centro del estudio clínico, debe dar el asentimiento informado en la selección y debe estar en condiciones de comprender que puede retirarse del estudio clínico en cualquier momento.
    7. El paciente y el (los) tutor(es) o cuidador(es) designado(s) está(n) en condiciones de comprender y cumplir de manera satisfactoria los requisitos del protocolo, según la evaluación del investigador.
    E.4Principal exclusion criteria
    1. The subject presents with a clinical presentation and/or history that is consistent with another neurologic condition that may have accompanying abnormal movements.
    These include, but are not limited to:
    - Transient Tic disorder
    - Huntington's disease
    - Parkinson's disease
    - Sydenham's chorea
    - Wilson's disease
    - Mental retardation
    - Pervasive developmental disorder
    - Traumatic brain injury
    - Stroke
    - Restless Legs Syndrome
    2. The subject has a history of schizophrenia, bipolar disorder, or other psychotic disorder.
    3. Subjects who receive psychostimulants for the treatment of ADD/ADHD and who have developed and/or had exacerbations of the tic disorder after the initiation of stimulant treatment (Note that subjects with ADD/ADHD who are treated with psychostimulants and have not developed new tics or a worsening of their current tics can be included if all other enrollment obligations are met).
    4. The subject currently meets DSM-IV-TR criteria for a primary mood disorder.
    5. The subject has severe obsessive-compulsive disease (OCD), as evidenced by a Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) score > 16.
    6. The subject has taken aripiprazole within 1 month (30 days) of the Screening visit.
    7. Subjects who received any investigational agent in a clinical trial within 30 days prior to Screening; or who were previously enrolled in Studies 31-10-272, 31-10-273, or 31-10-274; or who were randomized into a clinical trial with once-daily aripiprazole at any time.
    8. The subject has a history of neuroleptic malignant syndrome.
    9. Sexually active males who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during the trial and for 90 days following the last dose of study drug, or sexually active females of childbearing potential who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during the trial and for 30 days following the last dose of study drug. Abstinence will be permitted if it is confirmed and documented at every trial visit. If employing birth control, 2 of the following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device, birth control pill, birth control depot injections, implant, condom or sponge with spermicide.
    10. Females who are breast-feeding and/or who have a positive serum pregnancy test result prior to receiving trial drug.
    11. The subject represents a significant risk of committing suicide based on history (suicide attempt in past 1 year), routine psychiatric status examination, investigator?s judgment, or who have an answer of ?yes? on any question other than 1-3 (current or over the last 30 days) on the Baseline/Screening version of the Columbia-Suicide Severity Rating Scale (C-SSRS).
    12. Body weight is lower than 16 kg.
    13. Subjects who have taken neuroleptic or antiparkinson drugs less than 14 days prior to randomization.
    14. Subjects requiring cognitive-behavioral therapy (CBT) for
    Tourette's Disorder during the trial period. CBT for other nonexclusionary disorders must remain consistent throughout the trial.
    15. The subject has met DSM-IV-TR criteria for any significant psychoactive substance use disorder (abuse, dependence, and/or withdrawal) within the past 3 months.
    16. A positive drug screen for cocaine, alcohol, or other drugs
    of abuse (excluding caffeine, nicotine, or prescribed psychostimulants for ADD/ADHD). Investigators can chose to repeat a positive drug screen one time during Screening period after concurrence with the medical monitor. A second positive test for any drug of abuse would be exclusionary.
    17. Subject requiring medication not allowed per protocol.
    18. Use of any Cytochrome P450 (CYP)2D6 and CYP3A4 inhibitors or CYP3A4 inducers within 14 days prior to dosing and for the duration of the trial.
    19. Use of herbal medications of any kind and nutritional or dietary supplements for Tourette?s disorder within 7 days prior to dosing and for the duration of the trial.
    20. The inability to swallow tablets or tolerate oral medication.
    21. The following laboratory test results, vital sign, measurements, and electrocardiogram (ECG) results are exclusionary:
    1) Platelets <= 75,000/mm3
    2) Hemoglobin <= 9 g/dL
    3) Neutrophils, absolute <= 1000/mm3
    4) Aspartate aminotransferase (AST) > 3x ULN as defined by the central laboratory
    5) Alanine aminotransferase (ALT) > 3x ULN as defined by the central laboratory
    6) Creatinine >= 2 mg/dL
    7) Diastolic blood pressure > 105 mmHg
    8) QTc >= 450 msec on either the QTcB (Bazett's) or QTcF (Fridericia) corrections on 2 of 3 time points
    1. Paciente con un cuadro clínico y/o antecedentes
    compatibles con otra enfermedad neurológica con
    movimientos anormales, incluyendo, entre otras: Trastorno de tics transitorio, Enf. de Huntington, Enf. de Parkinson, Corea de Sydenham, Enf. de Wilson, Retraso mental, Trastorno generalizado del desarrollo, Lesión traumática del encéfalo, Accidente cerebrovascular, Sínd. de piernas inquietas
    2. Paciente con antecedentes de esquizofrenia, trastorno bipolar u otro trastorno psiquiátrico.
    3. Pacientes con tratamiento con psicoestimulantes para el TDA/TDAH y en los que se produjo y/o tuvieron agravamientos del trastorno de tics tras el inicio del tratamiento estimulante (pacientes con TDA/TDAH tratados con psicoestimulates y no nuevos tics ni empeoramiento de los actuales pueden incluirse si reúnen todas las demás criterios).
    4. Paciente reúne actualmente los criterios del DSM-IV-TR para un trastorno anímico primario.
    5. Paciente con enfermedad obsesiva-compulsiva (TOC) grave, comprobada mediante una puntuación >16 en la escala de CY-BOCS.
    6. Paciente ha tomado aripiprazol durante el mes (30 días) previo a la selección.
    7. Pacientes que recibieron cualquier fármaco en investigación durante los 30 días previos a la selección, o que participaron en los estudios 31-10-272, 31-10-273 o 31-10-274, o fueron aleatorizados para participar en un EC con aripiprazol de administración una vez al día en cualquier momento.
    8. El paciente tiene antecedentes de sínd. neuroléptico maligno.
    9. Hombres o mujeres capaces de procrear sexualmente activos que no se comprometan a utilizar 2 de los métodos anticonceptivos aprobados (vasectomía, ligadura de trompas, diafragma vaginal, dispositivo intrauterino, píldora anticonceptiva, inyecciones anticonceptivas de liberación prolongada, implante anticonceptivo, preservativo o esponja con espermicida.
    ) o que no se abstendrán de mantener relaciones sexuales durante el estudio clínico (EC). Y durante los 90 días posteriores a la última dosis del medicamento del estudio para hombres y los 30 días posteriores para las mujeres. La abstinencia sexual se permitirá si se confirma y se documenta en cada visita del EC.
    10. Mujeres lactantes y/o que tengan un resultado positivo en la prueba de embarazo en suero antes de recibir el fármaco del EC.
    11. Paciente con un riesgo importante de consumar el suicidio según sus antecedentes (intento de suicidio en el último año), el examen de rutina del estado psiquiátrico, el juicio del investigador o ha respondido ?sí? a cualquiera de las preguntas que no sean de la 1 a la 3 (actualmente o durante los últimos 30 días) en la versión para el inicio del estudio clínico/selección de la escala de C-SSRS.
    12. Peso corporal <16 kg.
    13. Pacientes que han tomado neurolépticos o antiparkinsonianos
    menos de 14 días antes de la aleatorización.
    14. Pacientes que necesiten terapia cognitivo-conductual para el síndrome de Gilles de la Tourette durante el período del EC. En el caso de otros trastornos, no excluyentes para el estudio, debe haber coherencia durante todo el EC.
    15. El paciente ha reunido los criterios del DSM-IV-TR para cualquier trastorno importante de uso de sustancias psicoactivas (abuso, dependencia y/o abstinencia) durante los últimos 3 meses.
    16. Resultado positivo en la prueba de detección de drogas de cocaína, alcohol u otras drogas (excepto cafeína, nicotina o psicoestimulantes recetados para el TDA/TDAH). Los investigadores pueden elegir repetir una prueba positiva de detección de drogas una vez durante el período de selección después de acordarlo con el monitor médico. Un segundo resultado positivo en la prueba de detección de cualquier droga será motivo de exclusión.
    17. Paciente necesita medicación no permitida según el protocolo.
    18. Uso de cualquier inhibidor del citocromo P450 (CTP)2D6 y CTP3A4 o inductores del CTP3A4 durante los 14 días anteriores a la administración del medicamento del EC y durante todo el EC.
    19. Uso de medicamentos a base de hierbas medicinales y suplementos nutricionales o dietéticos para el síndrome de Gilles de la Tourette durante los 7 días previos a la administración del medicamento del EC y durante todo el EC.
    20. Incapacidad para deglutir comprimidos o tolerar la medicación
    por vía oral.
    21. Los siguientes resultados en los análisis de laboratorio, determinaciones de constantes vitales y resultados de electrocardiogramas (ECG) son excluyentes:
    1) Plaquetas<=75.000/mm3
    2) Hemoglobina<=9 g/dl
    3) Neutrófilos, valor absoluto<=1000/mm3
    4) Aspartato-aminotransferasa (ASAT)>3 veces el límite superior de la normalidad (LSN) según lo definido por el laboratorio central
    5) Alanina-aminotransferasa (ALAT) >3xLSN según lo definido por el laboratorio central
    6) Creatinina>=2 mg/dl
    7) Tensión arterial diastólica>105 mmHg
    8) QTc>=450 mseg en las correcciones de los intervalos QTcB (fórmula de Bazett) o QTcF (fórmula Fridericia) en 2 de los 3 momentos.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline to endpoint on the Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS).
    Cambio desde los valores iniciales hasta los valores finales en la puntuación total de tics (TTS, por sus siglas en inglés) de la escala de gravedad global de tics de Yale (YGTSS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    8 weeks
    8 semanas
    E.5.2Secondary end point(s)
    Clinical Global Impressions Scale for Tourette's Syndrome (CGI-TS) change score at endpoint (change score obtained from CGI-TS improvement scale assessment).
    Cambio en la puntuación final de la escala CGI-TS (puntuación del cambio obtenido de la evaluación de la escala de mejoría de la escala CGI-TS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    8 weeks
    8 semanas
    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 Yes
    E.6.7Pharmacodynamic Yes
    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 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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Bulgaria
    Canada
    Finland
    Germany
    Hungary
    Italy
    Mexico
    Netherlands
    Peru
    Poland
    Romania
    Spain
    Sweden
    United Kingdom
    United States
    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
    Last Date of Contact or the Date of Final Contact Attempt from the Post-treatment Follow-up eCRF page for the last subject completing or withdrawing from the trial
    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 months0
    E.8.9.1In the Member State concerned days6
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 126
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 76
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 50
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 59
    F.4.2.2In the whole clinical trial 67
    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)
    Subjects who complete the trial through the Week 8 visit may be offered entry into an open-label safety trial of aripiprazole (Protocol 31-12-294) for an additional 52 weeks of open-label treatment and a 30-day follow-up. All subjects who do not enter the open-label trial (completers and subjects who receive at least one dose of trial drug and discontinue the trial for any reason) will be followed up for safety reasons 30 days after the last trial visit.
    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 Decision2013-01-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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