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    Summary
    EudraCT Number:2012-003310-14
    Sponsor's Protocol Code Number:SPD489-344
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-02-04
    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 number2012-003310-14
    A.3Full title of the trial
    The SPD489-344, Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-optimization Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults Aged 18-55 Years with Moderate to Severe Binge Eating Disorder
    Studio SPD489-344 di fase III, multicentrico, randomizzato, in doppio cieco, a gruppi paralleli, controllato con placebo, di ottimizzazione della dose, per valutare l’efficacia, la sicurezza e la tollerabilità di SPD489 in pazienti adulti di età compresa tra i 18 e i 55 anni affetti da disturbo da alimentazione incontrollata da moderato a grave.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to examine the efficacy and safety of study drug, SPD489, in adults subjects who are suffering from Binge Eating Disorder
    Uno studio per valutare la sicurezza e la tollerabilità di SPD489 nel trattamento di pazienti adulti affetti da disturbo da alimentazione incontrollata
    A.3.2Name or abbreviated title of the trial where available
    SPD489-344
    SPD489-344
    A.4.1Sponsor's protocol code numberSPD489-344
    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 SponsorShire Development, LLC
    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 supportShire Development LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationShire Pharmaceuticals Ltd
    B.5.2Functional name of contact pointMedical Communications
    B.5.3 Address:
    B.5.3.1Street AddressHampshire International Business Park
    B.5.3.2Town/ cityChineham, Basingstoke
    B.5.3.3Post codeRG24 8EP
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+448000556614
    B.5.5Fax number+441256894714
    B.5.6E-mailmedinfoglobal@shire.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 Vyvanse
    D.2.1.1.2Name of the Marketing Authorisation holderShire US 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 nameLisdexamfetamine dimesylate (LDX)
    D.3.2Product code SPD489
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLisdexamfetamine dimesylate
    D.3.9.1CAS number 608137-32-2
    D.3.9.2Current sponsor codeSPD489
    D.3.9.3Other descriptive nameLISDEXAMFETAMINE DIMESYLATE
    D.3.9.4EV Substance CodeSUB32146
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 Vyvanse
    D.2.1.1.2Name of the Marketing Authorisation holderShire US 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 nameLisdexamfetamine dimesylate (LDX)
    D.3.2Product code SPD489
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLisdexamfetamine dimesylate
    D.3.9.1CAS number 608137-32-2
    D.3.9.2Current sponsor codeSPD489
    D.3.9.3Other descriptive nameLISDEXAMFETAMINE DIMESYLATE
    D.3.9.4EV Substance CodeSUB32146
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Vyvanse
    D.2.1.1.2Name of the Marketing Authorisation holderShire US 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 nameLisdexamfetamine dimesylate (LDX)
    D.3.2Product code SPD489
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLisdexamfetamine dimesylate
    D.3.9.1CAS number 608137-32-2
    D.3.9.2Current sponsor codeSPD489
    D.3.9.3Other descriptive nameLISDEXAMFETAMINE DIMESYLATE
    D.3.9.4EV Substance CodeSUB32146
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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 placeboCapsule, hard
    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
    Binge eating disorder is characterized by recurrent, distressing episodes of uncontrolled consumption of large amounts of food (binge eating) without the inappropriate compensatory weight loss behaviors of bulimia nervosa. Though currently listed in the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) appendix as a disorder provided for further study, it has been recommended that BED be formally included as an eating disorder in DSM-V.
    il disturbo da alimentazione incontrollata è caratterizzato da episodi ricorrenti angoscianti di consumo incontrollato di grandi quantità di cibo(abbuffate)senza l’inappropriata compensativa perdita di peso caratteristica della bulimia nervosa.Sebbene attualmente elencata nell’app.del “Diagnostic and Statistical Manual of Mental Disorders-IV(DSM-IV)”come un disturbo contemplato per ulteriori studi,è stato raccomandato che BED sia formalmente incluso come un disturbo dell’alimentazione nel DSM-V
    E.1.1.1Medical condition in easily understood language
    Binge eating disorder
    disturbo da alimentazione incontrollata
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the efficacy of SPD489 compared with placebo in adults (18-55 years of age inclusive) with moderate to severe BED at Visit 8 (Weeks 11 and 12) as measured by the number of binge days (defined as days during which at least 1 binge episode occurs) per week as assessed by clinical interview based on subject diary.
    Dimostrare l’efficacia di SPD489 rispetto al placebo in pazienti adulti (di età compresa tra i 18 e i 55 anni compiuti) affetti da disturbo da alimentazione incontrollata (BED, Binge Eating Disorder) da moderato a grave alla visita 8 (settimane 11 e 12), mediante il calcolo dei giorni di abbuffate compulsive per settimana (ovvero giorni in cui si verifica almeno un episodio di abbuffata compulsiva), sulla base di un’intervista clinica che prende spunto dai dati riportati nel diario del soggetto.
    E.2.2Secondary objectives of the trial
    Key Secondary Objectives
    1. To demonstrate the efficacy of SPD489 compared with placebo on the global impressions of BED improvement as measured by the CGI-I scale at Visit 8 (Week 12)/ET.
    2. To demonstrate the efficacy of SPD489 compared with placebo on 4-week cessation from binge eating behavior (free from binge episodes in the respective period) for the last 28 days prior to Visit 8 (Week 12)/ET.
    3. To demonstrate the efficacy of SPD489 compared with placebo on the percent change from baseline (Visit 0) in body weight at Visit 8 (Week 12).
    4. To demonstrate the efficacy of SPD489 on obsessive/compulsive binge eating symptoms compared to placebo at Visit 8 (Week 12) as measured by the change from baseline (Visit 0) in the Y-BOCS-BE total score.
    5. To demonstrate the efficacy of SPD489 compared with placebo on the change from baseline (Visit -1) in TG from fasted samples at Visit 8 (Week 12).
    1.Dim.l’eff.di SPD489 rispetto al placebo sull’impressione globale relativa al miglioramento del BED misurata per mezzo della scala dell’impressione clinica globale di miglioramento (CGI-I) alla visita 8 (sett12)/al momento dell’interruzione anticipata.2.Dim.l’eff.di SPD489 rispetto al placebo misurata come un’interruzione di 4 sett.del comportamento di alimentazione incontrollata nei 28 gg precedenti la visita 8/l’interruzione anticipata.3.Dim.l’eff.di SPD489 rispetto al placebo misurata come variazione % del peso corporeo dal basale (v0) alla v8 (sett12).4.Dim.l’eff.di SPD489 sui sintomi di alimentazione ossessiva/compulsiva rispetto al placebo alla v8 (sett12), misurati come variazioni del punteggio complessivo della scala di valutazione ossessivo compulsiva Yale-Brown per l’alimentazione incontrollata (Y-BOCS-BE) rispetto al basale(v0).5.Dim.l’eff.di SPD489 rispetto al placebo misurata come variaz.dei triglic. (TG) prelevati da campioni a digiuno dal basale (v-1) alla v8 (sett12).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The subject cannot be enrolled in the study before all of the following inclusion criteria (including test results) are met:
    • Subject is between 18-55 years of age (or age of majority if greater than 18 years of age, as defined by local regulations), inclusive, at the time of consent.
    • Subject meets DSM-IV-TR criteria for a diagnosis of BED.
    • Subject’s BED is of at least moderate severity with subjects reporting at least 3 binge eating days per week for the 14 days prior to the Baseline Visit (Visit 0) as documented in the subject’s binge diary. A binge day is a day during which at least 1 binge eating episode occurs.
    • Subject must have a CGI-S score superior or equal (>=) to 4 at the Screening Visit (Visit -1) and Baseline Visit (Visit 0).
    • Subject has a BMI of superior or equal (>=) to 18 and inferior or equal (<=) to 45 at the Screening Visit (Visit -1) and the Baseline Visit (Visit 0).
    • Subject is able to provide written, personally signed, and dated informed consent to participate in the study before completing any study-related procedures.
    • Subject is willing and has an understanding and ability to fully comply with study procedures and restrictions defined in this protocol.
    • Soggetti di età compresa tra i 18 e i 55 anni compiuti (o in ogni caso soggetti che hanno raggiunto la maggior età, se superiore ai 18 anni, come prescritto dalle normative locali) al momento del consenso.
    • Soggetti che soddisfano i seguenti criteri per la diagnosi del BED, come indicato nel manuale diagnostico e statistico dei disturbi mentali (quarta edizione) – testo revisionato™ (DSM-IV-TR™).
    • Soggetti affetti come minimo da BED di grado moderato, caratterizzato da almeno tre giorni di abbuffate compulsive per settimana nei 14 giorni precedenti la visita basale (visita 0), come riportato nell'apposito diario del paziente. Un giorno di abbuffata compulsiva deve includere al meno un episodio di questo tipo.
    • Soggetti con punteggio CGI-S ≥4 alla visita di screening (visita -1) ed alla visita basale (visita 0).
    • Soggetti con indice di massa corporea (IMC) ≥18 e ≤45 alla visita di screening (visita -1) e alla visita basale (visita 0).
    • Soggetti disposti a e in grado di seguire pienamente le procedure dello studio e le restrizioni riportate nel protocollo.
    • Soggetti in grado di fornire un consenso informato scritto, firmato e datato, alla partecipazione allo studio prima di effettuare qualsiasi procedura prevista dallo studio.
    E.4Principal exclusion criteria
    Subjects are excluded from the study if any of the following exclusion criteria are met:
    • Subject has current diagnosis of bulimia nervosa or anorexia nervosa as defined by the SCID-I eating disorders module.
    • Subject is receiving psychotherapy (eg, supportive psychotherapy, cognitive behavior therapy, interpersonal therapy) or weight loss support (eg, Weight Watchers) for BED that began within the 3 months prior to the Screening Visit (Visit -1). Subjects who are receiving psychotherapy or weight loss support that was initiated greater or equal (>=) to 3 months prior to the Screening Visit (Visit -1) will be allowed to continue to receive psychotherapy or weight loss support during the study only if they agree to not make any changes in the frequency or nature of their psychotherapy or weight loss support during the course of this study.
    • Subject has a current comorbid Axis I or Axis II psychiatric disorder that is either controlled with medications prohibited in this study or is uncontrolled and associated with significant symptoms (note: subjects with mild mood or anxiety symptoms that do not meet criteria for Axis I disorder, do not require treatment based on the investigator’s assessment, and do not confound efficacy or safety assessments in the opinion of the examining investigator may be included).
    • Subject has a lifetime history of psychosis, mania, hypomania, dementia, or ADHD.
    • Subject is considered a suicide risk in the opinion of the investigator, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the investigator.
    • Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder in accordance with DSM-IV-TR criteria. Subjects with a lifetime history of amphetamine, cocaine, or other stimulant abuse and/or dependence will be excluded. Nicotine dependence is not exclusionary.
    • Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis, an infectious process requiring antibiotics, or diabetes), disability, or other condition that might confound the results of safety assessments administered in the study or that might increase risk to the subject. Subject will be excluded if he or she has any additional condition(s) that in the investigator’s opinion would prohibit the subject from completing the study or would not be in the best interest of the subject to participate in the study. This would include any significant illness or unstable medical condition that could lead to difficulty in complying with the protocol. Mild, stable asthma is not exclusionary.
    • Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant medication.
    • Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
    • Subject has any clinically significant ECG prior to the Baseline Visit (Visit 0).
    • Subject has any clinically significant laboratory abnormality prior to the Baseline Visit (Visit 0). Subjects with hypokalemia at the Screening Visit or prior to the Baseline Visit (Visit 0) will be excluded.
    • Subject has a history of moderate or severe hypertension or has a resting average (of 3 readings) sitting systolic blood pressure >139mmHg or an average (of 3 readings) diastolic blood pressure >89mmHg at the Screening Visit (Visit -1) and/or Baseline Visit (Visit 0). NOTE: Subjects with mild (Stage 1), well-controlled hypertension on a stable antihypertensive treatment regimen, defined as having maintained the current dose for a period of at least 3 months or longer at the time of the Screening Visit (Visit -1), are allowed.
    I soggetti che soddisfino uno qualsiasi dei seguenti criteri di esclusione non potranno prender parte allo studio:
    • Soggetti con diagnosi attuale di bulimia nervosa o anoressia nervosa come indicato nel modulo dei disturbi alimentari dell’SCID-I.
    • Soggetti in psicoterapia (ad es. psicoterapia di supporto, psicoterapia cognitivo-comportamentale, terapia interpersonale) o soggetti che hanno iniziato a frequentare un gruppo di sostegno per perder peso (ad es. Weight Watchers) per il disturbo di alimentazione incontrollata nei tre mesi precedenti alla visita di screening (visita -1). I soggetti in psicoterapia o che frequentano un gruppo di sostegno per perder peso da ≥3 mesi alla visita di screening (visita -1) potranno continuare la psicoterapia o la frequentazione del gruppo di sostegno durante lo studio solo se acconsentono a non effettuare alcuna modifica né alla frequenza delle visite né al tipo di psicoterapia o di gruppo di sostegno frequentato nel corso di tale periodo.
    • Soggetti affetti da comorbidità quali disturbi psichiatrici di asse I o II, controllati mediante l’uso di farmaci vietati nell'ambito del presente studio o non controllati ed associati a sintomi significativi. Nota: potranno essere inclusi nello studio soggetti caratterizzati da lievi sintomi dell’umore o di ansietà insufficienti per una diagnosi del disturbo di asse I e che, secondo lo sperimentatore, non necessitano trattamento, né comportano alcun rischio di inficiare le valutazioni di efficacia o sicurezza.
    • Soggetti con precedenti di lunga data di psicosi, mania, ipomania, demenza o ADHD.
    • Soggetti considerati a rischio di suicidio secondo lo sperimentatore, o soggetti che hanno tentato il suicidio o manifestano al momento ideazioni suicidarie attive. Soggetti con ideazioni suicidarie passive e intermittenti non vanno necessariamente esclusi, sempre sulla base della valutazione dello sperimentatore.
    • Soggetti con precedenti recenti (entro gli ultimi sei mesi) di sospetto abuso di stupefacenti o disturbi da dipendenza in accordo con i criteri del DSM-IV-TR. Soggetti con precedenti di lunga data di uso di amfetamine e cocaina, o di abuso e/o di dipendenza da altri stimolanti. La dipendenza da nicotina non è motivo di esclusione.
    • Soggetti affetti da patologia concomitante cronica o acuta (ad es. grave rinite allergica, processo infettivo che richiede uso di antibiotici, diabete), disabilità o altra patologia che potrebbe inficiare i risultati della valutazione di sicurezza condotta nel corso dello studio o che potrebbe aumentare i rischi per il soggetto. Soggetti affetti da patologie che, secondo lo sperimentatore, potrebbero compromettere il completamento dello studio da parte del soggetto o rendere nulli i benefici dello stesso. Tali affezioni comprendono malattie gravi o patologie cliniche instabili che potrebbero ostacolare il rispetto del protocollo. Potranno invece essere inclusi pazienti affetti da asma lieve e controllata.
    • Soggetti con precedenti noti di malattia cardiovascolare sintomatica, arteriosclerosi avanzata, anomalia
    cardiaca strutturale, cardiomiopatia, gravi anomalie del ritmo cardiaco, coronaropatia o altre patologie cardiache gravi che potrebbero aumentarne la vulnerabilità agli effetti simpatico-mimetici degli stimolanti.
    • Soggetti con precedenti familiari noti di morte cardiaca improvvisa o di aritmia ventricolare.
    • Soggetti con elettrocardiogramma clinicamente significativo prima della visita basale (visita 0).
    • Soggetti con anomalie di laboratorio clinicamente significative prima della visita basale (visita 0). Soggetti con stato di ipokalemia allo screening o prima della visita basale (visita 0).
    • Soggetti con antecedenti di ipertensione moderata o grave o soggetti la cui pressione sistolica media a riposo (su tre letture) in posizione seduta è >139 mmHg o la cui pressione diastolica media (su tre letture) è >89 mmHg alla visita di screening (visita -1) e/o alla visita basale (visita 0). NOTA: potranno essere inclusi allo studio i soggetti con ipertensione lieve e controllata (stadio 1), che seguono una terapia con un regime di trattamento antiipertensivo stabile, ovvero la cui dose non ha subito modifiche per almeno tre mesi o più alla visita di screening (visita -1).
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline to Visit 8 (Weeks 11 and 12) in the number of binge days per week. Baseline is defined as the weekly average of the number of binge days per week for the 14 days prior to the Baseline Visit (Visit 0).
    Variazione nel numero di giorni di abbuffate compulsive dal basale alla visita 8 (settimane 11 e 12). Il basale viene definito come la media settimanale dei giorni di abbuffate compulsive nei 14 giorni precedenti la visita basale (visita 0).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Subject Daily Diary: Visit 0 and Visit 8
    Diario giornaliero del soggetto: Visita 0 e Visita 8
    E.5.2Secondary end point(s)
    Key Secondary Efficacy Endpoints
    1. The CGI-I at Visit 8 (Week 12)/ET.
    2. Proportion of subjects with 4-week cessation from binge eating at for the last 28 days prior to Visit 8/ET.
    3. The percent change in body weight from Baseline Visit (Visit 0) to Visit 8 (Week 12).
    4. The change from baseline (Visit 0) in Y-BOCS-BE at Visit 8 (Week 12).
    5. The change from baseline (Visit -1) in TG from fasted samples at Visit 8 (Week 12).

    Secondary Efficacy Endpoints
    1. The change from screening (Visit -1) in TC from fasted samples at Visit 8 (Week 12).
    2. The change from screening (Visit -1) in HbA1c from fasted samples at Visit 8 (Week 12).
    3. The change from baseline in the number of binge episodes per week at Visit 8 (Weeks 11 and 12). Baseline is defined as the weekly average of the number of binge episodes per week for the 14 days prior to the Baseline Visit (Visit 0).
    4. The response status in binge eating behavior at Visit 8 (Weeks 11 and 12)/ET based on the number of binge episodes per week.
    5. The change from baseline (Visit 0) in Eating Inventory at Visit 8 (Week 12).
    6. The change from baseline (Visit 0) in the BES at Visit 8 (Week 12).
    7. The change from baseline (Visit 0) in the FrSBe at Visit 8 (Week 12).
    Principali endpoint secondari di efficacia
    1. CGI-I alla visita 8 (settimana 12)/al momento dell’interruzione anticipata.
    2. Percentuale dei soggetti che ottiene un’interruzione di quattro settimane degli episodi di abbuffate compulsive almeno 28 giorni prima della visita 8/dell’interruzione anticipata.
    3. Variazione percentuale del peso corporeo dalla visita basale (visita 0) alla visita 8 (settimana 12).
    4. Variazione del punteggio complessivo della scala Y-BOCS-BE dal basale (visita 0) alla visita 8 (settimana 12).
    5. Variazione nel livello di trigliceridi prelevati da campioni a digiuno dal basale (visita -1) alla visita 8 (settimana 12).

    Endpoint secondari di efficacia
    1. Variazione nel livello di colesterolo totale prelevato da campioni a digiuno dalla visita di screening (visita 1) alla visita 8 (settimana 12).
    2. Variazione nel livello di emoglobina glicata prelevata da campioni a digiuno dalla visita di screening (visita -1) alla visita 8 (settimana 12).
    3. Variazione nel numero di episodi di abbuffate compulsive settimanali dal basale alla visita 8 (settimane 11 e 12). Il basale viene definito come la media settimanale degli episodi di abbuffate compulsive nei 14 giorni precedenti la visita basale (visita 0).
    4. Stato di risposta a comportamenti di alimentazione incontrollata alla visita 8 (settimane 11 e 12)/al momento dell’interruzione anticipata sulla base del numero di episodi di abbuffate compulsive settimanali.
    5. Variazioni nel questionario Eating Inventory dal basale (visita 0) alla visita 8 (settimana 12).
    6. Variazioni della scala BES dal basale (visita 0) alla visita 8 (settimana 12).
    7. Variazioni della scala FrSBe dal basale (visita 0) alla visita 8 (settimana 12).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Key Secondary Efficacy Endpoints
    CGI-I: Visit 8/ET
    Subject Daily Diary: V6-V8/ET
    Weight: Visit 0 and Visit 8
    Y-BOCS-BE: Visit 0 and Visit 8
    TG: Visit -1 and Visit 8

    Secondary Efficacy Endpoints
    TC: Visit -1 and Visit 8
    HbA1c: Visit -1 and Visit 8
    Subject Daily Diary: Visit 0 and Visit 8
    Subject Daily Diary: Visit 8
    Eating Inventory: Visit 0 and Visit 8
    BES: Visit 0 and Visit 8
    FrSBe: Visit 0 and Visit 8
    Principali endpoint secondari di efficacia
    CGI-I: Visita 8/fine studio
    Diario giornaliero del soggetto: V6-V8/fine studio
    Peso: Visita 0 e Visita 8
    Y-BOCS-BE: Visita 0 e Visita 8
    TG: Visita -1 e Visita 8


    endpoint secondari di efficacia:
    TC: Visita -1 e Visita 8
    HbA1c: Visita -1 e Visita 8
    Diario giornaliero del soggetto: Visita 0 e Visita 8
    Diario giornaliero del soggetto: Visita 0
    Eating Inventory: Visita 0 e Visita 8
    BES: Visita 0 e Visita 8
    FrSBe: Visita 0 e Visita 8
    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 Yes
    E.6.12Pharmacoeconomic Yes
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Ottimizzazione della dose seguita dal mantenimento della dose
    Dose-optimization followed by Dose-maintenance
    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 trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    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
    The end of the trial is signified by the last patient finishing the last visit (the Follow-up Visit) of the trial.
    La conclusione della sperimentazione è definita come l’ultimo paziente che finisce l’ultima visita (visita di follow-up) della sperimentazione.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 356
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 85
    F.4.2.2In the whole clinical trial 356
    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)
    Eligible subjects will have the option to enter a 12-month open-label extension safety and tolerability study.
    I soggetti eleggibili avranno la possibilità di entrare in uno studio di estensione di 12-mesi, in aperto per la sicurezza e la tollerabilità.
    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 Decision2013-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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