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    Summary
    EudraCT Number:2012-004546-15
    Sponsor's Protocol Code Number:12-PP-12
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2013-06-19
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2012-004546-15
    A.3Full title of the trial
    Assessment of incidence of adverse events in a naive pediatric population treated with an antipsychotic drug over 12 months follow-up
    EVALUATION DE L’INCIDENCE DES EVENEMENTS INDESIRABLES EN POPULATION PEDIATRIQUE NAIVE TRAITEE PAR ANTIPSYCHOTIQUE AU COURS D’UN SUIVI DE 12 MOIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Unwanted events in naive pediatric population treated by antipsychotic
    Evénements indésirables en population pédiatrique naïve traitée par antipsychotique
    A.3.2Name or abbreviated title of the trial where available
    Unwanted events in naive pediatric population treated by antipsychotic
    Evénements indésirables en population pédiatrique naïve traitée par antipsychotique
    A.4.1Sponsor's protocol code number12-PP-12
    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 SponsorCHU de Nice
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCHU de Nice
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Nice
    B.5.2Functional name of contact pointCaillon
    B.5.3 Address:
    B.5.3.1Street AddressDRCI - 4 avenue reine victoria - hôpital de Cimiez
    B.5.3.2Town/ cityNice
    B.5.3.3Post code06001
    B.5.3.4CountryFrance
    B.5.4Telephone number003349204589
    B.5.5Fax number0033492034075
    B.5.6E-mailcaillon.c@chu-nice.fr
    D. IMP Identification
    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
    severe behavioral disorders in mental retardation,
    autistic syndromes
    schizophrenia
    psychosis
    Schizophrénie
    Austisme
    Psychose
    E.1.1.1Medical condition in easily understood language
    severe behavioral disorders in mental
    Troubles du comportement psychiatrique
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10033877
    E.1.2Term Paranoid type schizophrenia
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main purpose of this study is to evaluate the incidence of adverse events related to antipsychotic drugs in a French pediatric population with no history of taking antipsychotic drugs.
    L’objectif principal est d’établir l’incidence des EI sous antipsychotiques en population pédiatrique naïve, au cours d’un suivi de 12 mois.
    E.2.2Secondary objectives of the trial
    1) To study risk factors associated with the occurrence of adverse events

    2) Study risk factors associated with changing the antipsychotic drug used during study:
    • age at onset of treatment
    • pubertal status at baseline
    • age at onset of disorder for which the prescription of antipsychotic drug was indicated
    • the antipsychotic drug prescribed
    • other concomitant treatment(s)
    • the DSM-IV diagnosis
    3) Study of the persistence and/or reversibility of adverse events before the end of the study
    4) Evaluation of the evolution of the disorder’s severity
    5) Evaluation of the evolution of social functioning
    6) Evaluation of the evolution of the therapeutic alliance
    7) Evaluation of the evolution of quality of life
    8) Evaluation of the evolution of the eating behaviors
    9) Evaluation of the evolution of the physical activity
    1 Etudier les facteurs de risque potentiellement associés à la survenue des EI :
    2 Etudier les facteurs de risque associés au changement de molécule antipsychotique en cours d’étude selon :
    - la molécule antipsychotique donnée en première intention
    - l’âge à la mise sous traitement antipsychotique le stade pubertaire à l’inclusion
    l’âge de début de la maladie ayant justifié la prescription d’antipsychotique le(s) traitement(s) associé(s)
    les catégories diagnostiques DSM-IV-R
    3- Etude de la persistance et/ou de la réversibilité des EI chez les patients ayant interrompu le traitement par antipsychotique avant les 12 mois de l’étude.
    4- Evaluation de l’évolution de la sévérité de la maladie.
    5- Evaluation de l’évolution du fonctionnement social.
    6- Evaluation de l’évolution de l’alliance thérapeutique.
    7- Evaluation de l’évolution de la qualité de vie.
    8) Evaluation de l'évolution du comportement alimentaire
    9) Evaluation de l'activité physique
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Male or female patients
    •6 <Aged <18 years
    •In whom antipsychotic treatment is indicated
    •Who have never been treated with antipsychotic medication (other than metoclopramide (Primperan®) for pediatric indications).
    - Receiving an antipsychotic for less than 15 days
    - Without history of exhibition in an antipsychotic or with a history of grip of antipsychotic of less than three consecutive months interrupted for more than six months before the inclusion
    - Hospitalized ( e ) in full-time or day department, or seen ambulatory
    - Obtaining of the lit consent, the patient and his parents or the legal person in charge
    - Obtaining of the consent lit by the patient become major during the follow-up
    - Membership in a national insurance scheme
    - Garçons et filles
    - 6 < Age < 18 ans
    - Recevant un antipsychotique depuis moins de 15 jours
    - Sans antécédent d’exposition à un antipsychotique ou avec un antécédent de prise d’antipsychotique de moins de trois mois consécutifs interrompue depuis plus de six mois avant l’inclusion
    - Hospitalisé(e) en service temps plein ou de jour, ou vu en ambulatoire
    - Obtention du consentement éclairé, du patient et de ses parents ou du responsable légal
    - Obtention du consentement éclairé du patient devenu majeur au cours du suivi
    - Affiliation à un régime de sécurité sociale
    E.4Principal exclusion criteria
    none
    Aucun
    E.5 End points
    E.5.1Primary end point(s)
    A- Clinical Assessment
    1-General assessment of adverse events by the Pediatric Adverse Event Rating Scale (PAERS-Clinician) (March et al, 2007). The PAERS provides a convenient and simple way to ascertain adverse events in children and adolescents treated with atypical antipsychotic drugs.
    2-Somatic parameters to be monitored: weight, size, body mass index (BMI), abdominal perimeter, blood pressure, temperature.
    -Hypertension is defined as follows (Simonetti et al, 2010):
    Systolic blood pressure: from 1 to 17 years: > 100 + (age x 2) mm / Hg
    Diastolic blood pressure: from 1 to 10 years: > 60 + (age x 2) mm / Hg, from 11 to 17 years: > 70 + age mm / Hg
    Adolescents over 17 years: a systolic blood pressure > 160 mm / Hg or diastolic blood pressure > 90 mm / Hg.
    3-Electrocardiographic assessment of QT interval:
    The heart rate (in beats per minute), measured using the duration of the RR segment, and the uncorrected QT segment, will then be used to derive a value for the corrected QT interval, the QTc. A long QT interval will be defined as a QTc that is greater than 0.44 seconds.

    4-Neuromuscular adverse events:
    4.1-Abnormal Involuntary Movement Scale (AIMS) (Guy, 1976a)
    This scale, developed by the US National Institute of Mental Health (Guy, 1976a), has been used routinely since its publication for the systematic evaluation of tardive dyskinesia.
    4.2 -Barnes Akathisia Rating Scale (BARS) (Barnes, 1989)
    The Barnes Akathisia Rating Scale (BARS) is a heterogeneous evaluation specifically designed to assess akathisia secondary to the use of antipsychotics.
    4.3 Simpson Angus Scale (SAS) (Simpson and Angus, 1970)
    This scale evaluates Parkinsonism associated with the use of antipsychotic drugs.
    4.4-Bush Francis Catatonia Rating Scale (BFCRS) (Bush and al, 1996)
    The Bush Francis Catatonia Rating Scale (BFCRS) is the first instrument devised for the systematic and standardized examination of catatonia.
    B - Laboratory assessments
    The following laboratory tests will be obtained on each visit: complete blood count, liver enzymes, creatine phosphokinase, glycemia, cholesterol (total, light, and heavy), triglycerides, prolactin, insulin, vitamin D, CRPus, glyquée haemoglobin HbA1C, thyroidiennes hormones
    For every patient, blood tests will be collected two hours before the dose of atypical antipsychotic treatment is given.

    Adverse events are defined as follows:
    Hematologic adverse events: Eosinophilia (> 500 cells / mm ³ of blood), leukopenia (<4000 cells / mm ³ of blood), neutropenia (<1500 neutrophils / mm ³ of blood) by the blood count. Thrombocytopenia (<150,000 platelets / mm ³ of blood).
    Adverse events on liver function: Increased liver enzymes (ASAT, ALAT) > 25 IU / L (female), ASAT > 30 IU / L and ALAT > 35 IU / L (male).
    Neuromuscular adverse events: Elevation of plasma creatine phosphokinase (CPK) >150 IU / L.
    Metabolic adverse events (fasting measurements): Hyperglycemia: blood glucose ≥ 1 g / l in children, ≥ 1.1 g / l in adolescents. Hypertriglyceridemia: triglycerides ≥ 1 g / l under 10 years, ≥ 1.3 g / l older than 10 years. Hypercholesterolemia (total cholesterol > 1.7 g / l in children and adolescents).
    Hormonal adverse events: Hyperprolactinemia (> 20 ng / ml) or hypoprolactinemia (< 2 ng / ml) by assay of plasma prolactin. The prolactin assay is performed fasting, at the same time of day for each patient, ideally at 10 a.m., after 15 minutes of rest, in a calm atmosphere that minimizes stress. Prolactin assays vary according to each laboratory. Deficiency of 25-OH-vitamin D is defined as an assay of 25-OH-vitamin D < 30 ng / mL. Hyperinsulinemia is defined as ≥ 9 mIU / l (prepubertal) and ≥ 16 mIU / l (pubertal). Insulin resistance will be estimated using a laboratory calculation of the HOMA-IR (Homeostasis Model Assessment of Insulin Resistance): HOMA-IR = (insulin x glucose) / 22.5. Insulin resistance is considered present if the HOMA-IR is ≥ 2.1 (prepubertal); ≥ 3.9 (pubertal)
    A-Evaluation de la tolérance clinique
    1-Evaluation générale des EI : par la Pediatric Adverse Event Rating Scale (PAERS-Clinician)

    2-Evaluation des EI métaboliques
    - La variation dynamique de l’IMC (rapport poids/taille²) sera étudiée par la réalisation de la courbe de corpulence (fille et garçon) éditée par le Programme National Nutrition Santé (PNNS) 2006-2010
    - L’hypertension est définie (Simonetti et al, 2010) :
    HTA systolique :
    De 1 à 17 ans : > 100 + (âge x 2) mm/Hg
    HTA diastolique :
    De 1 à 10 ans : > 60 + (âge x 2) mm/Hg
    De 11à 17 ans : > 70 + âge mm/Hg
    Chez l’adolescent de plus de 17 ans : HTA systolique > 160 mm/Hg ou diastolique > 90 mm/Hg.
    - Anomalies électro-cardiographiques
    Il sera principalement recherché un QT long, segment mesuré sur l’électrocardiogramme (ECG).
    La fréquence cardiaque (en battements par minutes), dont sera déduit le segment RR et le QT mesuré (non corrigé) permettra de « calculer » le QTc. Un QT long est un segment QR supérieur à 0,44 secondes.

    3-Evaluation des EI Neuromusculaires
    - Une hyperthermie sera recherchée. La température sera considérée comme un EI si ≥ à 38°C.
    - Les mouvements involontaires faciaux, oraux et des extrémités des membres seront évalués par l’Abnormal Involuntary Movement Scale (AIMS)
    - L’akathisie par l’échelle d’akathisie de Barnes (Barnes, 1989)
    - L’échelle d’akathisie de Barnes (BARS) est une échelle d’hétéro-évaluation de 4 items évaluant spécifiquement l’akathisie secondaire à l’usage des antipsychotiques, sous ses aspects subjectifs et objectifs.
    - Le syndrome parkinsonien dû aux antipsychotiques mesuré par l’échelle de Simpson et Angus (Simpson et Angus, 1970)
    - La catatonie par la Bush Francis Catatonia Rating Scale (Bush et al, 1996)
    La Bush Francis Catatonia Rating Scale (BFCRS) est le premier instrument construit pour l'examen systématique, standardisé de la catatonie.

    B- Evaluation de la tolérance biologique
    1- EI hématologiques
    - Eosinophilie ( > 500 cellules/mm³ de sang), leucopénie ( < 4.000 éléments/mm³ de sang), neutropénie ( < 1.500 neutros/mm³ de sang), agranulocytose (< 500 neutros/mm³ de sang) par la numération formule sanguine.
    - Thrombopénie ( < 150.000 plaquettes/mm³ de sang) avec dosage du taux de plaquettes dans le sang.

    2-EI sur la fonction hépatique
    - Augmentation des enzymes hépatiques par dosage des taux suivants : transaminases (ASAT, ALAT). Pour les femmes taux > 25 UI/L, pour les hommes taux ASAT > 30 UI/L et ALAT > 35 UI/L.

    3-EI neuromusculaire
    - Elévation de la créatine phosphokinase (CPK) par le dosage plasmatique.
    La CK est libérée dans le sang lors de lésions tissulaires avec lyse cellulaire. Le taux de CPK peut être élevé sans symptôme moteur clinique. Le seuil de CPK > 150 UI/L est considéré comme EI.

    4-EI métaboliques
    Par le dosage à jeun du taux de glycémie, de triglycérides, de cholestérol total, HDL et LDL.
    - Hyperglycémie : glycémie ≥ 1 g/l chez l’enfant ; chez l’adolescent ≥ 1,1 g/l.
    - Hypertriglycéridémie : triglycérides ≥ 1 g/l avant 10 ans ; ≥ 1,3 g/l après 10 ans.
    - Hypercholestérolémie (cholestérol total chez l’enfant et l’adolescent > 1,7 g/l.
    - Dosage de la CRP US. Reconnu comme facteur prédictif du syndrome métabolique chez l’adulte : norme 0-5mg/L
    - dosage de l'hémoglobine glyquée : 5-EI hormonaux - Norme: 4 à 6 pourcent
    - Recherche d’une hyperprolactinémie (taux > 20 ng/ml) ou d’une hypoprolactinémie (taux < 2 ng/ml) par dosage plasmatique de la prolactine. Le dosage de la prolactine s’effectue à jeun, toujours à la même heure pour chaque patient, à 10 heures si possible, après 15 minutes de repos, dans une ambiance rassurante pour limiter le stress.
    Les dosages de la prolactine varient selon chaque laboratoire.
    - Recherche d’un déficit en 25-OH-vitamine D par le dosage de la 25-OH-vitamine D (taux < 30 ng/mL). La vitamine D, qu’elle soit d’origine cutanée ou alimentaire, est métabolisée par le foie en 25-OH-vitamine D, forme qui est dosable communément dans le sang.
    - Recherche d’un taux élevé de l’insulinémie ( ≥ 9 mUI/l si patient prépubère, ≥ 16 mUI/l si patient pubère). Avec calcul par le laboratoire de l’HOMA-IR (Homeostasis Model Assessment of Insulin Resistance) : HOMA-IR = (insuline x glucose) / 22,5 ; HOMA ≥ 2,1 si patient prépubère ; ≥ 3,9 si patient pubère.
    -Dosage des hormones thyroïdiennes (TSH, T3l, T4l) - TSH (0,15-3,8 mcU/ml), T3l (2,8-7,0 pmol/l), T4l (11-28 pmol/l)
    E.5.1.1Timepoint(s) of evaluation of this end point
    On inclusion,1 month, 3 months, 6 months, 9 months, 12 months after the visit of selection
    A l'inclusion, 1 mois, 3 mois, 6 mois, 9 mois et 12 mois après la visite de sélection
    E.5.2Secondary end point(s)
    Risk factors
    Tanner score of puberty at inclusion: population will be divided into three groups: prepubertal (stage ≤ 1); currently in puberty (stages 2 to 4) and puberty adult (stage 5).
    Drug history: age at initiation of treatment, the first-line atypical antipsychotic drug, other treatment(s), age of onset of disorder for which the prescription of an atypical antipsychotic drug was indicated.
    The diagnosis is made using the Schedule for Affective Disorders and Schizophrenia for School Age Children (Kiddie-SADS) (Kaufman and al, 1997), a semi-structured interview for patients aged 6 to 18 years. It was translated into French by Mouren-Simeoni in 2002. It establishes a categorical diagnosis based on criteria from the DSM-IV-R. It contains the CGAS.

    Persistence and/or reversibility of adverse events before the end of the study
    There is no official pharmacovigilance guidance on the persistence and reversibility of adverse events. We propose the following definitions for this study, based on published data and our preliminary study:
    • A persistent adverse event is an event that is still present 3 months after treatment cessation
    • A reversible adverse event is an event that has fully resolved 3 months after treatment cessation
    This group will be monitored using the same criteria as the group still receiving treatment, except for the laboratory and ECG assessments, which will be performed only on the last visit M12.
    The reason for treatment cessation will be noted in the visit subsequent to the decision to cease treatment.

    Evaluation of the evolution of disorder severity at baseline, M3, M6, M9 and M12
    The clinical severity of the disorder will be assessed using the Clinical Global Impressions Scales (CGI).
    The CGI was developed to provide a global measure of the severity of a patient’s clinical condition and improvement or deterioration during clinical studies.
    The clinician uses his or her clinical experience of this patient population to rate the severity of the patient’s current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).
    An experienced clinician can use the CGI after a short training session. It takes 1 to 2 minutes to score the CGI after a clinical interview.

    Evaluation of the evolution of social functioning at baseline, at M6 and at M12
    Social functioning will be assessed by the Child Global Assessment Scale (CGAS). The CGAS has been developed from the Global Assessment Scale (GAS) (Endicott and al, 1976). The French translation was done by Dugas (Dugas, 1989).
    It allows a rating of 0 to 100 in ten levels (1-10 level, 11-20 level, 21-30 level, 31-40 level, 41-50 level, 51-60 level, 61-70 level, 71-80 level, 81-90 level, 91-100 level).
    The levels are correlated with the intensity of symptoms.
    • The first level corresponds to a continual need for assistance with the activities of daily living.
    • The tenth level corresponds to no symptoms.
    It is easy to perform. The evaluation takes two minutes.
    The CGAS is contained in the Kiddie-SADS. It will be performed by the clinical psychologist in this form at the inclusion visit.

    Evaluation of the evolution of therapeutic alliance at baseline, at M3, at M6, at M9 and at M12
    The evolution of the therapeutic alliance will be assessed through Helping Alliance Questionnaire (HAQ).
    This is a self-administered questionnaire created in the United States by Luborsky. This questionnaire includes three versions (child/adolescent’s version, parents’ version and therapist’s version).
    Kermarrec et al. have validated a French adaptation for child/adolescent and for parents (Kermarrec et al, 2003). This is the only validated scale that has been translated into French.
    For this study, only the child/adolescent’s version will be used.
    This self-administered questionnaire includes 15 items leading to two types of responses: an ordinal response for the first thirteen items and response chart as a visual analogue scale for the last two items. Thirteen items are scored from 1 (completely disagree) to 6 (completely agree). This subscore reflects the level of therapeutic alliance.
    The time taken to complete the self-assessment is estimated at ten minutes.
    The total scores range from 13 to 78. The higher the score, the greater the quality of the therapeutic alliance. To date, no threshold for a “good therapeutic alliance” has been defined.

    Evaluation of the evolution of quality of life at baseline, M3, M6, M9 and M12
    We will use a self-administrated-questionnaire (Sheehan Disability Scale).

    Evaluation of the evolution of the eating behaviors at baseline, M1, M3, M6, M9, M12
    We will use a questionnaire : Questionnaire of Eating and Weight Patterns with child and parent-report

    Evaluation of the evolution of the physical activity at baseline, M1, M3, M6, M9, M12
    We use Dennison measure.
    1 - Facteurs de risques associés à la survenue d’EI. Les critères suivants seront recueillis
    2-Facteurs de risques associés à un changement de molécule antipsychotique pour une autre molécule antipsychotique au cours du suivi
    3-Persistance et/ou réversibilité des EI chez les patients ayant arrêté le traitement par antipsychotique prescrit initialement
    Il n’existe pas de définition officielle de pharmaco-vigilance sur ce critère.
    4-Evolution de la sévérité de la maladie à baseline, M3, M6, M9 et M12
    La sévérité de la maladie sera évaluée par l’échelle Clinical Global Impressions Scales (CGI).
    La CGI a été développée pour fournir une mesure de la sévérité de la maladie d'un patient et de l'amélioration pendant des études cliniques (Guy W, 1976b).

    5- Evolution du fonctionnement social à baseline, M6 et M12
    Le fonctionnement social sera évalué par l’échelle d’évaluation globale de l’enfant (CGAS).

    6- Evolution de l’alliance thérapeutique à baseline, M3, M6, M9 et M12
    L’évolution de la qualité de l’alliance thérapeutique, au cours du suivi, sera évaluée par l’échelle Helping Alliance Questionnaire (HAQ).

    2.7 Evolution de la qualité de vie à baseline, M3, M6, M9 et M12
    Pour évaluer l’évolution de la qualité de vie au cours du suivi, nous utiliserons l’auto-questionnaire Sheehan Disability Scale (SDS) (Leon et al, 1992). L'échelle évalue trois domaines : scolaire, social et familial. Elle génère 4 scores: un score pour chaque domaine (allant de 0 à 10) et un score total. (par l’addition des 3 scores). Le score maximal est de 30.
    Cet outil a été adapté pour la population pédiatrique (Whiteside, 2009). Pour l’étude, il sera utilisé les deux versions : pour le patient et pour le parent. Echelle analogique très facile à remplir et rapide.
    Cet outil est disponible en 41 langues ou variantes linguistiques dont le français.

    2.8 Evaluation du comportement alimentaire à baseline, M1, M3, M6, M9, M12
    L’étude du comportement alimentaire (en particulier de type binge) sera évalué par l’échelle Questionnaire of Eating and Weight Patterns (QEWP) (Johnson et al, 1999). Il s’agit d’une étude validée en population pédiatrique de 10 à 18 ans. Constituée de deux versions : pour le patient et pour le parent. Ces deux versions seront utilisées dans l’étude. Chaque version est composée de 21 questions. Le score total permet de définir trois catégories de diagnostics : pas de diagnostic, pas de signe clinique de binge, diagnostic de binge.
    Cette échelle a déjà été utilisée pour évaluer le comportement alimentaire de patients traités par olanzapine et clozapine (Theisen et al, 2003).
    Cette échelle sera traduite en français pour l’étude. Elle ne présente pas de propriété psychométrique dépendante de la langue. Elle ne nécessite pas de validation de son contenu pour son utilisation. Ne pose pas le problème de la validation interjuge et ne présente pas de droit d’auteur.




    2.9 Evaluation de l’activité physique à baseline, M1, M3, M6, M9, M12
    Pour évaluer l’activité physique du sujet, le questionnaire de Dennison sera utilisé (Dennison et al, 1988). Il est étudié sept variables : dormir, regarder la télévision, jeux inactifs, inactivité, petite activité physique (comme lire un livre), activité physique modérée (comme parler), activité physique intense (comme courir). Chaque variable est cotée en nombre d’heure effectué par jour dans la semaine, en nombre d’heure effectué le samedi et en nombre d’heure effectué le dimanche.
    Dans le cadre de l’étude, les questions seront posées directement à l’adolescent âgé de 12 à 18 ans, pour les patients de moins de 12 ans, les questions seront posées aux parents.
    Cette échelle sera traduite en français pour l’étude. Elle ne présente pas de propriété psychométrique dépendante de la langue. Elle ne nécessite pas de validation de son contenu pour son utilisation. Ne pose pas le problème de la validation interjuge et ne présente pas de droit d’auteur.
    E.5.2.1Timepoint(s) of evaluation of this end point
    On inclusion, 1 month, 3 months, 6 months, 9 months, 12 months
    A l'inclusion, 1 mois, 3 mois, 6 mois, 9 mois et 12 mos après la visite de sélection
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Pharmacovigilance
    Pharmacovigilance
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.3 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 concerned10
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    La visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months36
    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: 340
    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: 170
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 170
    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 state340
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 340
    F.4.2.2In the whole clinical trial 340
    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)
    At the end, the patient will follow for its pathology.
    A la fin de l'étude le patient sera suivi de manière habituelle pour sa pathologie.
    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 Decision2012-12-06
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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