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    Summary
    EudraCT Number:2012-003489-42
    Sponsor's Protocol Code Number:31-12-294
    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:2013-02-21
    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 number2012-003489-42
    A.3Full title of the trial
    An Open-Label, Multicenter Study Evaluating the Safety and Tolerability of Once-daily Oral Aripiprazole in Children and Adolescents with Tourette’s Disorder
    Uno studio multicentrico in aperto per la valutazione della sicurezza e della tollerabilità di aripiprazolo somministrato per via orale una volta al giorno 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 of aripiprazole in children and adolescents with Tourette’s Disorder
    Studio clinico per testare la sicurezza di di aripiprazolo in bambini e adolescenti affetti da sindrome di Tourette
    A.4.1Sponsor's protocol code number31-12-294
    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 AuthorisationEuropean Union
    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 AuthorisationEuropean Union
    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 AuthorisationEuropean Union
    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
    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 evaluate the long-term safety and tolerability of aripiprazole once-daily treatment with oral tablets in children and adolescents (7 -17 years of age) with a diagnosis of Tourette’s Disorder
    Valutare la sicurezza e la tollerabilità a lungo termine del trattamento con aripiprazolo somministrato una volta al giorno sotto forma di compresse orali in bambini e adolescenti (7-17 anni) con diagnosi di sindrome di Tourette
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of once-daily aripiprazole in the suppression of tics in children and adolescents with a diagnosis of Tourette’s Disorder, as measured by change from Baseline to endpoint on the TTS of the YGTSS
    valutare l’efficacia di aripiprazolo somministrato una volta al giorno nella soppressione dei tic in bambini e adolescenti con diagnosi di sindrome di Tourette, misurata dal cambiamento tra la visita basale e l’endpoint nel Total Tic score (TTS - Punteggio totale dei tic) della Yale Global Tic Severity Scale (YGTSS - Scala di severità globale dei tic).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent must be obtained from a legally acceptable representative (eg, guardian or caregiver), in accordance with requirements of the trial center’s IRB/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 Baseline and as such must be able to understand that he or she can withdraw from the trial at any time.
    2. 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.
    3. The subject completed Trial 31-12-293. Subjects who completed the Week 8 visit of Trial 31-12-293 are defined as trial completers.
    1)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 ai requisiti stabiliti dal comitato di revisione istituzionale e 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.
    2)Secondo le valutazioni del ricercatore, 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.
    3)Il soggetto ha completato lo studio 31-12-293. I soggetti che hanno completato la visita della Settimana 8 dello studio 31-12-293 sono definiti come soggetti che hanno completato lo studio.
    E.4Principal exclusion criteria
    1. The subject experienced AEs during the double-blind trial that would, in the investigator's judgment, preclude further exposure to aripiprazole.
    2. The subject had protocol violations during the double-blind trial considered major in the judgment of the investigator (significant noncompliance, use of prohibited concomitant medications, concern with use of drugs of abuse, etc.), which would deem them poor candidates for this trial.
    3. A positive drug screen at Baseline (ie, Day 0/last visit of double-blind trial, Protocol 31-12-293) for cocaine, alcohol, or other drugs of abuse (excluding caffeine, nicotine, or prescribed psychostimulants for ADD/ADHD) which will result in early termination on Week 1.
    4. 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.
    5. Females who have a positive urine pregnancy test result prior to receiving trial drug, or are pregnant or lactating.
    6. The subject represents a significant risk of committing suicide based on a routine psychiatric status examination, investigator’s judgment or who have an answer of “yes” on any question other than 1-3 on the C-SSRS.
    7. Body weight is lower than 16 kg.
    8. The following vital signs and ECG results are exclusionary:
    1) Diastolic blood pressure > 105 mmHg
    2) QTc ≥ 450 msec on either the QTcB (Bazett’s) or QTcF (Fridericia) corrections on 2 of 3 time points (see NOTE below)

    The following laboratory test results will result in discontinuation at the Week 1 visit:
    1) Platelets ≤ 75,000/mm3
    2) Hemoglobin ≤ 9 g/dL
    3) Neutrophils, absolute ≤ 1000/mm3
    4) Aspartate aminotransferase (AST) > 3 x ULN as defined by the central laboratory
    5) Alanine aminotransferase (ALT) > 3 x ULN as defined by the central laboratory
    6) Creatinine ≥ 2 mg/dL
    NOTE: In addition, subjects should be excluded (or discontinued at the Week 1 visit for abnormal laboratory tests) if they have any other vital sign results or ECG findings which in the investigator’s judgment are medically significant and would impact the safety of the subject or the interpretation of the trial results. Criteria are provided in the protocol to assist investigators in their assessments of results that may be potentially medically significant, depending on the subject’s medical history and clinical presentation.
    1)Durante lo studio precedente, il soggetto ha risentito di EA che, secondo le valutazioni del ricercatore, precludono un’ulteriore esposizione all’aripiprazolo.
    2)Secondo le valutazioni del ricercatore, il soggetto ha violato in modo grave il protocollo nel corso dello studio precedente (comportamento palesemente non conforme, uso di medicinali concomitanti proibiti, sospetto abuso di droghe, ecc.) e tali violazioni ne fanno un candidato inadeguato al presente studio.
    3)Interruzione anticipata alla visita della Settimana 1 se il soggetto risulta positivo all'alcol, alla cocaina o ad altre droghe (ad eccezione di caffeina, nicotina o psicostimolanti assunti su prescrizione per il trattamento di ADD/ADHD) alla visita basale (cioè Giorno 0/ultima visita dello studio precedente).
    4)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. Se si adottano metodi di controllo delle nascite, devono essere scelte 2 delle seguenti precauzioni: vasectomia, legatura delle tube, diaframma vaginale, dispositivo intrauterino, pillola contraccettiva, iniezioni contraccettive a lento rilascio, impianto, preservativo o tampone spermicida.
    5)Donne in gravidanza o in allattamento o con test di gravidanza delle urine positivo prima della somministrazione del medicinale sperimentale.
    6)Soggetti con rischio significativo di suicidio determinato in base all’esame periodico sulle condizioni psichiatriche o alle valutazioni del ricercatore, o che hanno risposto sì a una delle domande, escluse quelle dalla 1 alla 3, della C-SSRS.
    7)Peso corporeo inferiore a 16 kg.
    8)Sono criteri di esclusione i seguenti valori legati a segni vitali ed ECG:
    1)Pressione arteriosa diastolica > 105 mmHg
    2)QTc ≥ 450 ms con correzione QTcB (Bazett) o QTcF (Fridericia) su 2 dei 3 punti temporali (vedere la NOTA qui di seguito)
    I seguenti risultati dei test di laboratorio determineranno un’interruzione anticipata alla visita della Settimana 1:
    1)Piastrine ≤ 75.000/mm3
    2)Emoglobina ≤ 9 g/dl
    3)Neutrofili assoluti ≤ 1000/mm3
    4)Aspartato aminotransferasi (AST) > 3 x limite alto della norma (ULN) come definito dal laboratorio centrale
    5)Alanina aminotransferasi (ALT) > 3 x ULN come definito dal laboratorio centrale
    6)Creatinina ≥ 2 mg/dl
    NOTA: inoltre, i soggetti devono essere esclusi (o la loro partecipazione deve essere interrotta alla visita della Settimana 1 per risultati anomali dei test di laboratorio) qualora qualsiasi altro valore relativo a segni vitali o ECG, secondo le valutazioni del ricercatore, sia clinicamente significativo e possa interferire con la sicurezza del soggetto o con l'interpretazione dei risultati dello studio. I criteri sono indicati per assistere i ricercatori nelle loro valutazioni dei risultati potenzialmente significativi dal punto di vista medico, in base alla presentazione e all’anamnesi medica del soggetto.
    E.5 End points
    E.5.1Primary end point(s)
    Safety, including the following:
    • AEs
    • Laboratory tests (haematology, serum chemistry [including prolactin and thyroid stimulating hormone (TSH)], urinalysis, and pregnancy tests)
    • Vital signs
    • ECGs
    • AIMS and other EPS scales
    • C-SSRS
    • ADD/ADHD Subscale of SNAP-IV
    • CY-BOCS
    • CDRS-R
    • PARS
    • Body weight
    • Waist circumference
    • Body mass index (BMI)
    Le valutazioni di sicurezza includono
    • EA
    •Analisi di laboratorio (ematologia, chimica del siero [inclusi livelli di prolattina e TSH], analisi delle urine e test di gravidanza)
    •Segni vitali
    •ECG
    •AIMS e altre scale per i SEP
    •C-SSR
    •SNAP-IV
    •CY-BOCS
    •CDRS-R
    •PARS
    •Peso corporeo
    •Circonferenza della vita
    •IMC
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    Settimana 52
    E.5.2Secondary end point(s)
    • Change from Baseline to endpoint in YGTSS TTS
    • Mean CGI-TS change score at endpoint (change score obtained from CGI-TS improvement scale assessment)
    • Change from Baseline to endpoint in CGI-TS severity score
    • Mean change from Baseline to endpoint in Total YGTSS score
    • Response rates (clinical response will be defined as > 25% improvement from Baseline to endpoint in YGTSS TTS OR a CGI-TS change score of 1 [very much improved] or 2 [much improved] at endpoint)
    • Treatment discontinuation rates
    •Variazione da basale ad endpoint della YGTSS TTS
    •Punteggio medio della variazione della CGI-TS all’endpoint (punteggio della variazione ottenuto dal miglioramento della CGI-TS)
    •Tassi di risposta (la risposta clinica sarà definita come miglioramento > 25% dal basale all’endpoint della YGTSS TTS O punteggio di variazione della CGI-TS di 1 [migliorato moltissimo] o 2 [migliorato molto] all’endpoint)
    •Tassi di sospensione del trattamento
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 52
    Settimana 52
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) 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 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
    Belgium
    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 months6
    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 months9
    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: 96
    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: 58
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 38
    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 46
    F.4.2.2In the whole clinical trial 96
    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)
    There are no post trial treatment plans. All subjects (completers and subjects who receive at least 1 dose of trial drug and discontinue the trial for any reason) will be followed up for safety reasons 30 days (+ or - 3 days) after the last trial visit. Follow-up will consist of telephone contact to assess any AEs experienced since the last trial visit and information on ongoing AEs and serious AEs (SAEs) and recording of concomitant medications.
    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 Decision2013-03-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-10-27
    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
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