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    EudraCT Number:2019-001807-19
    Sponsor's Protocol Code Number:TV50717-CNS-30081
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-05
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-001807-19
    A.3Full title of the trial
    An Open-Label, Long-Term Safety, Tolerability, and Efficacy Study of TEV50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents (Open RECLAIM-DCP)
    Studio in aperto su sicurezza, tollerabilità ed efficacia a lungo termine di TEV-50717 (Deutetrabenazina) per il trattamento della discinesia nella paralisi cerebrale in bambini ed adolescenti (Open RECLAIM-DCP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Test if TEV-50717 is Safe and Effective in Relieving Abnormal Involuntary Movements in Cerebral Palsy
    Studio per valutare la sicurezza e l’efficacia di TEV-50717 nell’alleviare i movimenti involontari anomali nella paralisi cerebrale
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberTV50717-CNS-30081
    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.1.3.4CountryUnited 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 supportTeva Branded Pharmaceutical Products R&D, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTeva Branded Pharmaceutical Products R&D, Inc.
    B.5.2Functional name of contact pointClinical Trial Manager
    B.5.3 Address:
    B.5.3.1Street Address41 Moores Road
    B.5.3.2Town/ cityFrazer, Pennsylvania
    B.5.3.3Post code19355
    B.5.3.4CountryUnited States
    B.5.4Telephone number00197298361100
    B.5.5Fax number0000000000
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTEV-50717 (deutetrabenazina)
    D.3.2Product code [TEV-50717]
    D.3.4Pharmaceutical form Coated 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 INNDeutetrabenazine
    D.3.9.1CAS number 1392826-25-3
    D.3.9.2Current sponsor codeTEV-50717
    D.3.9.3Other descriptive nameDEUTETRABENAZINE
    D.3.9.4EV Substance CodeSUB179485
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdeutetrabenazine
    D.3.9.1CAS number 1392826-25-3
    D.3.9.2Current sponsor codeTEV-50717
    D.3.9.3Other descriptive namedeutetrabenazine
    D.3.9.4EV Substance CodeSUB179485
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdeutetrabenazine
    D.3.9.1CAS number 1392826-25-3
    D.3.9.2Current sponsor codeTEV-50717
    D.3.9.3Other descriptive namedeutetrabenazine
    D.3.9.4EV Substance CodeSUB179485
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    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. cell therapy medicinal product Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy 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
    Dyskinesia in cerebral palsy (DCP)
    Discinesia nella paralisi cerebrale
    E.1.1.1Medical condition in easily understood language
    Dyskinesia in cerebral palsy (DCP)
    Discinesia nella paralisi cerebrale
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10013916
    E.1.2Term Dyskinesia
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the safety and tolerability of long-term therapy with TEV-50717 in children and adolescents with DCP.
    L’obiettivo primario di questo studio è valutare la sicurezza e la tollerabilità della terapia a lungo termine con TEV-50717 in bambini e adolescenti con DCP.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to evaluate the efficacy of longterm therapy with TEV-50717 in reducing the severity of DCP.
    L’obiettivo secondario di questo studio è valutare l’efficacia della terapia a lungo termine con TEV-50717 nel ridurre la gravità della DCP.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients who have completed Study TV50717-CNS-30080 have already met the criteria below:
    a. Patient ha completed parent Study TV50717-CNS-30080.
    b. Patient weighs at least 12 kg (26 lb) on day 1 of this study.
    c. Patient is able to swallow TEV-50717 tablet whole.
    d. Patient and caregiver/adult are willing to adhere to TEV-50717 regimen and comply with all study procedures.
    e. Patient is in good general health, as indicated by medical and psychiatric history and physical and neurological examination.
    f. In the investigator's opinion, the patient and caregiver/adult have the ability to understand the nature of the study and its procedures, and the patient is expected to complete the study as designed.
    g. For a patient who is a minor, the parent(s)/legal guardian(s) provides written informed consent, and the patient provides assent (in accordance with local regulations). Adult patients (in accordance with local regulations) provide their own written informed consent.
    h. A caregiver provides written informed consent after being assigned the role by an adult patient or if this role is delegated by the parent/legal guardian of a patient who is a minor.
    i. Females who are postmenarchal or =12 years of age whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods for the duration of the study (ie, starting at day 1) and for 30 days after last dose of TEV-50717.
    iIle pazienti che hanno completato lo Studio TV50717-CNS-30080 hanno già soddisfatto i criteri seguenti:
    a. Il/La paziente ha completato lo Studio originale TV50717-CNS-30080.
    b. Il/La paziente pesa almeno 12 kg (26 lb) il giorno 1 di questo studio.
    c. Il/La paziente è in grado di deglutire TEV-50717 intero.
    d. Il/La paziente e il caregiver/adulto concordano di aderire al regime di TEV-50717 e di seguire tutte le procedure dello studio.
    e. Il/La paziente è in buono stato di salute generale, come indicato dall’anamnesi medica e psichiatrica e dall’esame obiettivo e neurologico.
    f. Secondo il parere dello sperimentatore, il/la paziente e il caregiver/adulto sono in grado di capire la natura dello studio e le sue procedure e si prevede che il/la paziente completi lo studio come progettato.
    g. Nel caso di un/a paziente minorenne, il/i genitore/i o il/i tutore/i legale/i fornisce/forniscono il consenso informato scritto e il/la paziente fornisce l’assenso (in base alla normativa locale). Conformemente alla normativa locale, i pazienti adulti forniscono il proprio consenso informato scritto.
    h. Un/a caregiver fornisce il consenso informato scritto dopo l’assegnazione di tale ruolo da parte di un/a paziente adulto/a o nel caso in cui il ruolo venga delegato dal genitore/tutore legale di un/a paziente minorenne.
    i Le pazienti di sesso femminile che hanno già avuto le mestruazioni o che hanno un’età =12 e i cui partner maschili sono potenzialmente fertili (cioè non sono stati sottoposti a vasectomia), devono usare metodi contraccettivi altamente efficaci per la durata dello studio (cioè a partire dal giorno 1) e per 30 giorni dopo l’ultima dose di TEV-50717.
    E.4Principal exclusion criteria
    Patients will not be randomized/enrolled in this study if they meet any of the following criteria:
    a. Patient has clinically significant depression at day 1 of this study. Note: Patients receiving antidepressant therapy may be enrolled if on a stable dose.
    b. Patient has a history of suicidal intent or related behaviors: (i) previous intent to act on suicidal ideation with a specific plan, irrespective of level of ambivalence, at the time of suicidal thought; (ii) previous suicidal preparatory acts or behaviour.
    c. Patient has a history of a previous actual, interrupted, or aborted suicide attempt.
    d. Patient has a first-degree relative who has completed suicide.
    e. Patient who is currently receiving or who has received botulinum neurotoxin (BoNT) in an investigational clinical trial. Note: Patients may be included in the study if they have at least 2 treatments of Food and Drug Administration-approved BoNT at a regular interval (eg, every 3 to 4 months), in reasonably stable dosages and locations (subject to investigator's judgement) to treat lower limb spasticity or dystonia. "Food and Drug Administration-approved BoNT" is to be defined as an FDA-approved compound, not necessarily an FDAapproved treatment for children. BoNT treatments other than FDAapproved drugs can be submitted to the medical monitor for consideration.
    f. Patient has received any of the following concomitant medications for dystonia or chorea within the specified exclusionary windows of day of this study: (a) within 3 months: depot neuroleptics; (b) within 30 days: tetrabenazine or valbenazine; (c) within 21 days: reserpine; (d) within 14 days: neuroleptics (oral), typical and atypical antipsychotics, metoclopramide, levodopa, dopamine agonists, and monoamine oxidase inhibitors.
    g. Patient has received treatment with stem cells, deep brain stimulation, transmagnetic stimulation, or transcranial direct current stimulation for treatment of abnormal movements or CP, or the patient is not in a stable clinical condition.
    h. Patient has recent surgical procedure or is anticipated to have a surgical procedure during the study that, in the opinion of the investigator, makes the patient unsuitable for the
    i. Patient has a severe mental disability or an unstable or serious medical illness (eg, epilepsy) that, in the opinion of the investigator, could jeopardize or would compromise the patient's ability to participate in this study.
    j. Patient has a QT interval (QTc) corrected for heart rate using Fridericia's formula (QTcF) value >450 msec on 12-lead ECG at day 1 of this study.
    k. Patients with a history of torsade de pointes, congenital long QT syndrome, bradyarrhythmias, other cardiac arrhythmias, or uncompensated heart failure.
    l. Patient has evidence of hepatic impairment, as indicated by the following: (a) aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5× the upper limit of the normal range (ULN) at day 1 of this study; (b) alkaline phosphatase (ALP) or total bilirubin (Tbil) >2×ULN at day 1 of this study. Note: Patients with Gilbert's syndrome are eligible to participate if approved by the medical monitor. Note: Patients with abnormalities in 2 or more of the following clinical laboratory parameters must be approved for enrollment by the medical monitor: AST, ALT, ALP, and Tbil.
    m. Patient has evidence of clinically significant renal impairment, indicated by a serum creatinine >1.5×ULN at day 1 of this study.
    n. Patient has a known allergy to any of the components of TEV-50717.
    o. Patient has participated in an investigational drug or device study other than Study TV50717-CNS-30080 and received IMP/intervention within 30 days or 5 drug half-lives of day 1 of this study, whichever is longer.
    p. Patient is pregnant or breastfeeding.

    Please refer to study synopsis for the complete list of exclusion criteria
    I/le pazienti saranno esclusi/e dalla partecipazione a questo studio se soddisfaranno uno qualsiasi dei seguenti criteri:
    a. Il/La paziente è affetto/a da depressione clinicamente significativa il giorno 1 di questo studio.
    Nota: i/le pazienti che ricevono terapia antidepressiva possono essere arruolati/e se assumono una dose stabile.
    b. Il/La paziente ha un’anamnesi di intento di suicidio o comportamenti correlati:
    ¿ precedente intenzione di mettere in atto un’ideazione di suicidio con un piano specifico, indipendentemente dal livello di ambivalenza al momento del pensiero di suicidio
    ¿ precedenti atti o comportamenti preparatori al suicidio
    c. Il/La paziente ha un’anamnesi di tentativo di suicidio precedente effettivo, interrotto o fallito.
    d. Il/La paziente ha un parente di primo grado che si è suicidato/a.
    e. Il/La paziente sta ricevendo o ha ricevuto la neurotossina botulinica (BoNT) in una sperimentazione clinica.
    Nota: i/le pazienti possono essere inclusi/e nello studio se hanno ricevuto almeno 2 trattamenti di BoNT approvati dalla Agenzia per gli alimenti e i medicinali ad intervalli regolari (ad es. ogni 3-4 mesi) in dosaggi e sedi ragionevolmente stabili (in base al giudizio dello sperimentatore) per il trattamento della spasticità o distonia degli arti inferiori.
    Il trattamento "BoNT approvato dalla Agenzia per gli alimenti e i medicinali” deve essere definito come composto approvato dalla FDA, non necessariamente come trattamento approvato dalla FDA per i bambini. I trattamenti BoNT diversi dai farmaci approvati dalla FDA possono essere inviati al monitor clinico per le considerazioni del caso.
    f. Il/La paziente ha ricevuto uno qualsiasi dei seguenti medicinali concomitanti per la distonia o la corea entro la finestra di esclusione specificata del giorno 1 di questo studio:
    ¿ entro 3 mesi: neurolettici ad azione prolungata
    ¿ entro 30 giorni: tetrabenazina o valbenazina
    ¿ entro 21 giorni: reserpina
    ¿ entro 14 giorni: neurolettici (orali), antipsicotici tipici e atipici, metoclopramide, levodopa, agonisti della dopamina e inibitori della monoamino ossidasi
    g. Il/La paziente ha ricevuto il trattamento con cellule staminali, stimolazione cerebrale profonda, stimolazione transmagnetica, o stimolazione con corrente transcranica diretta per il trattamento di movimenti anormali o paralisi cerebrale, o il/la paziente non è in condizione clinica stabile.
    h. Il/La paziente è stato/a sottoposto/a a una procedura chirurgica o si prevede che debba essere sottoposto/a a una procedura chirurgica durante lo studio che, a parere dello sperimentatore, rende il/la paziente non adatto/a allo studio.
    i. Il/La paziente ha una grave disabilità mentale o una malattia instabile o grave (ad es. epilessia) che, a parere dello sperimentatore, potrebbe mettere a repentaglio o comprometterebbe la capacità del/della paziente di partecipare a questo studio.
    j. Il/La paziente ha un intervallo QT corretto per la frequenza cardiaca (QTc) usando il valore della formula di Fridericia (QTcF) >450 msec all’ECG a 12 derivazioni il giorno 1 di questo studio.
    k. Pazienti con anamnesi di torsioni di punta, sindrome del QT lungo congenito, bradiaritmie, altre aritmie cardiache o insufficienza cardiaca scompensata.
    l. Il/La paziente presenta evidenza di compromissione epatica, indicata da quanto segue:
    ¿ aspartato aminotransferasi (AST) o alanina aminotransferasi (ALT) >2.5× il limite superiore dell’intervallo normale (ULN) il giorno 1 di questo studio
    ¿ fosfatasi alcalina (ALP) o bilirubina totale (Tbil) >2×ULN al giorno 1 di questo studio
    Nota: i/le pazienti con sindrome di Gilbert sono idonei/e a partecipare se approvato dal monitor clinico.
    Nota: l’arruolamento di pazienti con anomalie in 2 o più dei seguenti parametri clinici di laboratorio deve essere approvato dal monitor clinico: AST, ALT, ALP e Tbil.

    Ci si riferisca alla sinossi per la lista completa dei criteri di esclusione
    E.5 End points
    E.5.1Primary end point(s)
    The safety measures/endpoints are as follows:
    • adverse events
    • vital signs
    • children's C-SSRS (Columbia-Suicide Severity Rating Scale)
    • ECG (electrocardiogram) parameters
    • clinical laboratory parameters (hematology, serum chemistry, and urinalysis)
    • ESRS (Extrapyramidal Symptom Rating Scale - subscales I and II)
    • CBCL (Child Behaviour Checklist)
    • ESS (Epworth Sleepiness Scale)
    I parametri/gli endpoint di sicurezza sono i seguenti:
    • eventi avversi
    • parametri vitali
    • C-SSRS (Columbia-Suicide Severity Rating Scale, Scala di valutazione della gravità del suicidio della Columbia) nei bambini
    • parametri dell’ECG (elettrocardiogramma)
    • parametri clinici di laboratorio (ematologia, ematochimica e analisi delle urine)
    • ESRS (Extrapyramidal Symptom Rating Scale- subscales I and II, Scala di valutazione dei sintomi extrapiramidali - sottoscale I e II)
    • CBCL (Child Behaviour Checklist, Lista di controllo del comportamento del bambino)
    • ESS (Epworth Sleepiness Scale, Scala della sonnolenza di Epworth)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1 to each visit the assessments are performed/scale is administered until W55 (End of Study).
    Dal giorno 1 a ogni visita in cui sono effettuate le valutazioni/somministrate le scale fino alla S55 (Fine dello studio).
    E.5.2Secondary end point(s)
    The efficacy measures/endpoints are as follows:
    • MD-CRS (Movement Disorder-Childhood Rating Scale) part I total score
    (physician rated)
    • MD-CRS (Movement Disorder-Childhood Rating Scale) part II total score (physician rated)
    • MD-CRS Global Index (calculated from MD-CRS parts I and II total scores)
    • CaGI-I (Caregiver Global Impression of Improvement) (global, caregiver rated)
    • CGI-I (Clinical Global Impression of Improvement) (global, physician rated)
    • CGI-S (Clinical Global Impression of Severity) (global, physician rated)
    • PEDI-CAT (Pediatric Evaluation Disability Inventory-Computer Adapted Test) (activities of daily living, caregiver completed, content-balanced version)
    • UHDRS-TMS (Unified Huntington's Disease Rating Scale-Total Motor Score) (physician rated)
    • COPM (Canadian Occupational PErformance Measure) (physician rated)
    I parametri/gli endpoint di efficacia sono i seguenti:
    • MD-CRS (Movement Disorder-Childhood Rating Scale, Scala di valutazione dei disturbi del movimento nell’infanzia), punteggio totale parte I (valutata dal medico)
    • MD-CRS (Movement Disorder-Childhood Rating Scale, Scala di valutazione dei disturbi del movimento nell’infanzia), punteggio totale parte II (valutata dal medico)
    • Indice globale della MD-CRS (valutato in base ai punteggi totali delle parti I e II della MD-CRS)
    • CaGI-I (Caregiver Global Impression of Improvement, Impressione globale del miglioramento da parte del/la caregiver) (globale, valutata dal/la caregiver)
    • CGI-I (Clinical Global Impression of Improvement, Impressione globale clinica del miglioramento) (globale, valutata dal medico)
    • CGI-S (Clinical Global Impression of Severity, Impressione globale clinica della gravità) (globale, valutata dal medico)
    • PEDI-CAT (Pediatric Evaluation Disability Inventory- Computer Adapted Test, Questionario di valutazione della disabilità in pediatria - modificato per il test computerizzato) (Attività quotidiane, completato dal/la caregiver, versione con bilanciamento del contenuto)
    • UHDRS-TMS (Unified Huntington’s Disease Rating Scale, Scala di valutazione della malattia di Huntington unificata - punteggio motorio totale) (valutata dal medico)
    • COPM (Canadian Occupational Performance Measure, Misura canadese delle prestazioni lavorative) (valutata dal medico)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1/week 1/week 14 to each visit the scale is administered until W5354-55 (depending on the scale).
    Giorno 1/settimana 1/settimana 14 di ciascuna visita in cui sono effettuate fino alla S53- 54-55 (a seconda della scala).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. 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 No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Russian Federation
    United States
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of study is defined as the date of the week 55 follow-up telephone contact of the last participant.
    Justification: Week 55 is a telephone contact for safety assessments that occurs about 2 weeks after stopping deutetrabenazine. As the patient will have already been assessed by a face-to-face visit on Week 54 after 1 week washout, there is no need for an additional face-to face visit at Week 55.
    La fine dello studio è definita come la data del contatto telefonico di follow-up alla settimana 55 dell’ultimo partecipante.
    Motivazione: La settimana 55 è un contatto telefonico per le valutazioni della sicurezza che avviene circa 2 settimane dopo l’interruzione della deutetrabenazina. Poiché il paziente sarà già stato valutato durante una visita di persona alla settimana 54 dopo 1 settimana di washout, non vi è l’esigenza di un’ulteriore visita di persona alla settimana 55.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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.1.1.1In 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. of subjects for this age range: 85
    F.1.1.6Adolescents (12-17 years) Yes
    F. of subjects for this age range: 85
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 15
    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 Yes
    F. of subjects incapable of giving consent
    Patients below the age of 14 require informed consent or co-consent for patients 14 years of age and older, where applicable.
    I pazienti di età inferiore a 14 anni necessitano di consenso mentre i pazienti di età pari o superiore a 14 anni necessitano di co-consenso, ove applicabile
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 185
    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)
    None - There are no plans to provide further treatment to patients upon completion of the study. An extension to the study may be considered on an annual basis.
    Nessuno - Non ci sono piani per fornire ulteriore trattamento ai pazienti al completamento dello studio. Un'estensione dello studio può essere presa in considerazione su base annuale.
    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 Decision2019-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-18
    P. End of Trial
    P.End of Trial StatusOngoing
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