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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   38179   clinical trials with a EudraCT protocol, of which   6271   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).
     
    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:2012-003488-23
    Sponsor's Protocol Code Number:31-12-293
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-12-21
    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 ConcernedItaly - Italian Medicines Agency
    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
    Studio multicentrico, randomizzato, in doppio cieco, controllato verso placebo per la valutazione della sicurezza e dell'efficacia di una dose di aripiprazolo somministrato una volta al giorno per via orale in bambini e adolescenti affetti da sindrome di 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
    Studio clinico per testare la sicurezza e l'efficacia di aripiprazolo verso placebo in bambini e adolescenti con sindrome di 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 AND COMMERCIALISATION 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.5.3.4CountryItaly
    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 AuthorisationUnited Kingdom
    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.3.4Pharmaceutical 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 AuthorisationUnited Kingdom
    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.3.4Pharmaceutical 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.3.4Pharmaceutical 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 AuthorisationUnited Kingdom
    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.3.4Pharmaceutical 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
    Tic associati a sindrome di Tourette in bambini e adolescenti
    E.1.1.1Medical condition in easily understood language
    Sudden, repetitive and involuntary physical movements and vocal
    utterances associated with Tourette's Disorder
    Improvvisi, ripetitivi e involontari movimenti fisici e vocali associati alla sindrome di 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.
    confrontare l'efficacia dell'aripiprazolo rispetto al placebo nella soppressione dei tic in bambini e adolescenti (7-17 anni) con una diagnosi di sindrome di 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
    valutare la sicurezza e la tollerabilità del trattamento con una dose di aripiprazolo somministrato una volta al giorno tramite compresse orali in bambini e adolescenti con una diagnosi di sindrome di 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.Il soggetto è un bambino o un adolescente di sesso maschile o femminile con un'età di 7-17 anni (inclusi) al momento della firma dell'assenso/consenso informato.
    2. Il soggetto soddisfa i criteri diagnostici attuali DSM-IV-TR per la sindrome di Tourette, secondo quanto confermato da K-SADS-PL, tra cui il Supplemento Diagnostico 5 (abuso di sostanze e altre malattie, ad es. disturbi da tic).
    3. Il soggetto ha un punteggio TTS  20 sulla scala YGTSS allo screening e al basale (randomizzazione).
    4. Il soggetto, una persona che si occupa delle cure e lo sperimentatore devono essere tutti d'accordo sul fatto che i sintomi dei tic presenti provocano problemi nella quotidianità del soggetto, ovvero nei risultati accademici, nell'efficienza in termini lavorativi, nelle attività e/o relazioni sociali.
    5. I soggetti femminili in età fertile (in base al menarca e non sottoposte a sterilizzazione chirurgica/isterectomia) devono essere negativi al test di gravidanza, devono adottare metodi contraccettivi a doppia barriera (o possono confermare l'astinenza durante ciascuna visita pianificata) e non devono essere in stato di gravidanza o in fase di allattamento.
    6.Prima dell’avvio di qualsiasi procedura richiesta dal protocollo, è necessario ottenere un consenso informato da un rappresentante legalmente accettabile (ad es. il tutore o la persona che presta le cure), in conformità alle leggi locali, ai requisiti stabiliti dal comitato di revisione istituzionale o dal comitato etico indipendente del centro dello studio. Inoltre, il soggetto, come disposto dal comitato di revisione istituzionale o dal comitato etico indipendente del centro dello studio, deve fornire il consenso informato nella fase di screening e di conseguenza essere in grado di comprendere di avere la facoltà di ritirarsi dallo studio in qualsiasi momento.
    7. Secondo le valutazioni dello sperimentatore, il soggetto e le persone che prestano le cure o i tutori designati sono in grado di comprendere e rispettare in modo soddisfacente i requisiti del protocollo.
    E.4Principal exclusion criteria
    1. The subject presents with a clinical presentation and/or history that isconsistent with another neurologic condition that may have accompanying abnormal movements.
    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.
    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 (CYBOCS) 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.
    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 basedon history 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 within the past 3 months.
    16. A positive drug screen for cocaine, alcohol, or other drugs of abuse
    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 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
    1.Il soggetto si presenta con una condizione e/o un'anamnesi che è coerente con altre condizioni neurologiche che possono essere accompagnate da movimenti anomali.
    2.Il soggetto ha un'anamnesi di schizofrenia, disturbo bipolare o altri disturbi psicotici.3.I soggetti a cui sono somministrati
    psicostimolanti per il trattamento di ADD/ADHD e che hanno sviluppato e/o hanno subito aggravamenti del tic dopo l'inizio del trattamento di stimolazione.4.Il soggetto rientra attualmente nei criteri DSM-IV-TR per un disturbo umorale primario.5.Il soggetto è affetto da disturbo ossessivo-compulsivo grave, come indicato da un punteggio sulla scala CY-BOCS (Children's Yale-Brown Obsessive Compulsive Scale) &gt; 16
    6.Il soggetto ha assunto aripiprazolo entro 1 mese (30 giorni) prima della visita di screening.7.I soggetti che hanno ricevuto agenti in fase di sperimentazione in uno studio clinico 30 giorni prima dello screening; che sono stati reclutati in precedenza negli studi 31-10-272, 31-10-273 o 31-10-274; o che sono stati randomizzati in uno studio clinico che prevedeva la somministrazione di aripiprazolo 1 volta al giorno, in qualsiasi momento.
    8.Il soggetto ha un'anamnesi di sindrome neurolettica maligna.9.Gli uomini sessualmente attivi che non si impegneranno ad utilizzare 2 dei metodi di controllo delle nascite approvati o che non si asterranno dai rapporti durante lo studio e per 90 giorni dopo l’ultima dose del medicinale oggetto dello studio, oppure le donne sessualmente attive in età fertile che non si impegneranno ad utilizzare 2 dei metodi di controllo delle nascite approvati o che non si asterranno dai rapporti durante lo studio e per 30 giorni dopo l'ultima dose del medicinale oggetto dello studio. L’astinenza sarà consentita se confermata e documentata ad ognuna delle visite dello studio. 10.Donne in allattamento e/o che presentano un esito del test di gravidanza ematologico positivo prima di ricevere il medicinale oggetto dello studio.
    11.Il soggetto mostra un rischio significativo di suicidio in base all’anamnesi all’esame periodico sulle condizioni psichiatriche, alle valutazioni dello sperimentatore, o ha risposto “sì” a tutte le domande diverse da 1-3 (attualmente o negli ultimi 30 giorni) alla versione alla visita basale/di screening della Columbia-Suicide Severity Rating Scale (C-SSRS - Scala di Columbia per la valutazione della gravità di suicidio).
    12.Peso corporeo inferiore a 16 kg.
    13.Soggetti che hanno assunto medicinali neurolettici o anti-Parkinson nei 14 giorni precedenti la randomizzazione.14.Soggetti che necessitano di terapia cognitivo-comportamentale (TCC) per sindrome di Tourette durante il periodo dello studio. La TCC per altri disturbi che non rappresentano criteri di esclusione deve continuare in modo coerente per tutta la durata dello studio.15.Il soggetto ha soddisfatto i criteri DSM-IV-TR per ogni significativo abuso di sostanze psicoattive nel corso degli ultimi 3 mesi.16.Test per la presenza di droga positivo per cocaina, alcol o altre droghe 17.Il soggetto richiede la somministrazione di un medicinale non consentito dal protocollo.18.Uso di ogni inibitore del citocromo P450 (CYP)2D6 e CYP3A4 oppure induttore del CYP3A4 nei 14 giorni precedenti la somministrazione e per la durata dello studio.19.Uso di medicinali naturali di qualsiasi tipo e di integratori nutrizionali e alimentari per la Sindrome di Tourette nei 7 giorni precedenti la somministrazione del medicinale e per la durata dello studio.20.Incapacità di inghiottire compresse o tollerare medicinali per via orale.21. Sono criteri di esclusione i seguenti risultati di test di laboratorio, segni vitali, misurazioni ed ECG (elettrocardiogramma):1) Piastrine 75.000/mm3 Emoglobina 9 g/dl Neutrofili 1000/mm3 AST) &gt; 3 x ULN ALT) &gt; 3 x ULN Creatinina  2 mg/dl PAD &gt; 105 mmHg QTc  450 ms
    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).
    Variazione media da basale ad endpoint nel punteggio totale della YGTSS
    E.5.1.1Timepoint(s) of evaluation of this end point
    8 weeks
    8 settimane
    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).
    Punteggio medio della variazione della CGI-TS all’endpoint (punteggio della variazione ottenuto dalla valutazione della scala di miglioramento CGI-TS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    8 weeks
    8 settimane
    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 concerned8
    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
    Canada
    Mexico
    Peru
    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
    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 years0
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months18
    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 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.1.3Elderly (>=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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 59
    F.4.2.2In the whole clinical trial 126
    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.
    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 Decision2013-01-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-18
    P. End of Trial
    P.End of Trial StatusCompleted
    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
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA