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    Summary
    EudraCT Number:2012-003309-91
    Sponsor's Protocol Code Number:SPD489-343
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-01-22
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2012-003309-91
    A.3Full title of the trial
    The SPD489-343, 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
    Estudio SPD489-343 de fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y optimización de la dosis para evaluar la eficacia, seguridad y tolerabilidad de SPD489 en adultos de 18 a 55 años de edad con trastorno por atracón moderado o 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
    Estudio para determinar la eficacia y seguridad del producto en
    investigación, SPD489, en sujetos adultos que padecen de trastorno por
    atracón.
    A.3.2Name or abbreviated title of the trial where available
    SPD489-343
    A.4.1Sponsor's protocol code numberSPD489-343
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00021977
    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.
    El trastorno por atracón se caracteriza por episodios recurrentes y angustiosos de consumo incontrolado de grandes cantidades de alimentos (atracón), sin ir acompañados por la conducta compensatoria para perder peso asociada a la bulimia nerviosa. Aunque actualmente se incluye en el anexo del manual DSM-IV como un trastorno propuesto para estudios posteriores, se ha recomendado que el TPA se incluya formalmente como un trastorno alimentario en el manual DSM-V.
    E.1.1.1Medical condition in easily understood language
    Binge eating disorder
    trastorno por atracón
    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.
    Demostrar la eficacia de SPD489 en comparación con placebo en adultos (de 18 a 55 años ambos inclusive) con TPA moderado o grave en la visita 8 (semanas 11 y 12), determinada mediante el número de días de atracón (definido como los días durante los que se produce al menos 1 episodio de atracón) a la semana evaluados mediante entrevista clínica basada en el diario del paciente.
    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 obsesive/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. Demostrar la eficacia de SPD489 en comparación con placebo en las impresiones globales de la mejoría del TPA determinadas mediante la Escala CG-I, en la visita 8.
    2. Demostrar la eficacia de SPD489 en comparación con placebo para conseguir 4 semanas sin atracones (sin episodios de atracones en el periodo correspondiente) en los últimos 28 días antes de la visita 8.
    3. Demostrar la eficacia de SPD489 en comparación con placebo en el % de cambio con respecto al valor basal (visita 0) en el peso corporal en la visita 8 (semana 12).
    4. Demostrar la eficacia de SPD489 en los síntomas del trastorno por atracón obsesivo/compulsivo en comparación con placebo en la visita 8 (semana 12), determinada mediante el cambio con respecto al valor basal en la puntuación total en la Escala Y-BOCS-BE.
    5. Demostrar la eficacia de SPD489 en comparación con placebo en el cambio con respecto al valor basal (visita -1) en los triglicéridos (TG) en muestras obtenidas en ayunas en la visita 8.
    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.
    No se podrá incluir a un paciente en el estudio hasta que no se cumplan todos los criterios de inclusión siguientes (incluyendo los resultados de las pruebas):
    * El paciente tiene entre 18 (o, si las leyes locales fijan la mayoría de edad en una edad superior, la edad a la que se alcance la mayoría) y 55 años de edad, ambos inclusive, en el momento del consentimiento.
    * Pacientes que cumplan los siguientes criterios de diagnóstico del TPA del manual DSM-IV-TR.
    * Pacientes con TPA de al menos gravedad moderada que hayan referido haber tenido al menos 3 días de atracón por semana durante los 14 días previos a la visita basal (visita 0), anotados en el diario del paciente. Un día con atracón es un día durante el que al menos se produce un episodio de este tipo.
    * El paciente debe tener una puntuación mayor o igual a 4 en la escala CGI-S en la visita de selección (visita -1) y en la visita basal (visita 0).
    * El paciente debe tener un IMC comprendido mayor igual a 18 y menor o igual a 45 en la visita de selección (visita -1) y en visita basal (visita 0).
    * El paciente es capaz de otorgar por escrito, firmar personalmente y fechar el consentimiento informado para participar en el estudio antes de realizarle cualquier procedimiento relacionado con el estudio.
    * El paciente está dispuesto a cumplir plenamente los procedimientos y restricciones del estudio definidos en el presente protocolo, y los entiende y es capaz de cumplirlos.
    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 either 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.
    Los pacientes serán excluidos del estudio si cumplen alguno de los siguientes criterios:
    * Se ha diagnosticado al paciente bulimia nerviosa o anorexia nerviosa, según lo definido en el módulo de los trastornos alimentarios de la SCID-I.
    * El paciente está recibiendo psicoterapia (p. ej., psicoterapia de apoyo, terapia cognitivo conductual, terapia interpersonal) o ayuda para perder peso (p. ej., entulínea®), que inició en los 3 meses previos a la visita de selección (visita -1). A los pacientes que reciban psicoterapia o ayuda para perder peso que hayan iniciado hace 3 meses o más antes de la visita de selección (visita -1) se les permitirá continuar la psicoterapia o la ayuda para perder peso durante el estudio, solo si se comprometen a no realizar ningún cambio en la frecuencia o naturaleza de su psicoterapia o ayuda para la pérdida de peso durante este estudio.
    * Pacientes que padecen un trastorno psiquiátrico asociado del Eje I o del Eje II que se controla con medicamentos prohibidos en este estudio o no está controlado y se asocia a síntomas significativos (nota: se puede incluir a pacientes con síntomas de trastorno del estado de ánimo o ansiedad leves que no cumplan los criterios para trastornos del Eje I, que no requieran tratamiento según la evaluación del investigador y que no interfieran en las evaluaciones de la eficacia y seguridad según la opinión del investigador).
    * Pacientes con antecedentes de psicosis, manía, hipomanía, demencia o TDAH.
    * Pacientes con antecedentes recientes (en los últimos 6 meses) de sospecha de abuso o dependencia de sustancias o trastorno de dependencia según los criterios del manual DSM-IV-TR. Se excluirá a los pacientes con antecedentes de abuso y/o dependencia de anfetaminas, cocaína u otros estimulantes. La dependencia de la nicotina no se considera motivo de exclusión.
    * Pacientes con una enfermedad concurrente aguda o crónica (como rinitis alérgica intensa, un proceso infeccioso que requiera antibióticos o diabetes), discapacidad u otras enfermedades que pudieran interferir en los resultados de las evaluaciones de seguridad realizadas en el estudio o que pudieran aumentar el riesgo del paciente. Se excluirá a los pacientes que padezcan alguna otra enfermedad que, en opinión del investigador, impediría al paciente completar el estudio o que haría que la participación en el estudio no fuera lo mejor para el paciente. Esto incluiría, cualquier enfermedad significativa o trastorno médico inestable que pudiera dificultar el cumplimiento del protocolo. El asma leve y estable no se considera un motivo de exclusión.
    * Pacientes con antecedentes conocidos de enfermedad cardiovascular sintomática, arterioesclerosis avanzada, anomalías cardíacas estructurales, miocardiopatía, anomalías graves del ritmo cardíaco, arteriopatía coronaria u otros problemas cardíacos graves que puedan hacer que se aumente la vulnerabilidad a los efectos simpaticomiméticos de un medicamento estimulante.
    * Pacientes con antecedentes familiares conocidos de muerte súbita cardíaca o arritmia ventricular.
    * Pacientes que presenten cualquier ECG clínicamente significativo antes de la visita basal (visita 0).
    * Pacientes que presenten cualquier anomalía clínicamente significativa en la analítica antes de la visita basal (visita 0). Los pacientes con hipopotasemia en la visita de selección o antes de la visita basal (visita 0) serán excluidos del estudio.
    * Pacientes con antecedentes de hipertensión moderada o grave o que tengan una presión arterial sistólica media en sedestación y en descanso (3 lecturas) > 139 mmHg o una presión arterial diastólica media (3 lecturas) > 89 mmHg en la visita de selección (visita -1) y/o en la visita basal (visita 0). NOTA: se permite la inclusión de pacientes con hipertensión leve (nivel 1) bien controlada con una tratamiento antihipertensor estable, definido como el mantenimiento de la dosis actual durante un periodo de al menos 3 meses o más en el momento de la visita de selección (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).
    Cambio respecto al valor basal hasta la visita 8 (semanas 11 y 12) en el número de días con atracón por semana. El valor basal se define como el promedio semanal del número de días con atracón por semana durante los 14 días anteriores a la visita basal (visita 0).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Subject Daily Diary: Visit 0 and Visit 8
    Diario del sujeto: visita 0 a 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).
    Criterios secundarios clave de valoración de la eficacia:
    1. CGI-I en la visita 8 (semana 12)/FP.
    2. Porcentaje de pacientes con interrupción de los atracones durante 4 semanas en los 28 días previos a la visita 8/FP.
    3. Porcentaje de cambio en el peso corporal desde la visita basal (visita 0) hasta la visita 8 (semana 12).
    4. Cambio respecto al valor basal (visita 0) en la puntuación total en la escala Y-BOCS-BE en la visita 8 (semana 12).
    5. Cambio respecto al valor basal (visita -1) en los niveles de TG en muestras obtenidas en ayunas en la visita 8 (semana 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
    CGI-I: Visita 8/FT
    Subject Diario: V6-V8/FT
    Pso: Visita 0 and Visita 8
    Y-BOCS-BE: Visita 0 and Visita 8
    TG: Visita -1 y Visita 8
    TC: Visita -1 y Visita 8
    HbA1c: Visita -1 y Visita 8
    Diario del sujeto: Visita 0 y Visita 8
    Diario del sujeto: Visita 8
    Inventario alimentacion: Visita 0 yVisita 8
    BES: Visita 0 y Visita 8
    FrSBe: Visita 0 y 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
    Optimización de dosis seguido de dosis de mantenimiento
    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.
    El final del estudio está definido por la fecha de la última visita del último paciente del ensayo (visita de seguimiento)
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-25
    P. End of Trial
    P.End of Trial StatusCompleted
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