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    Summary
    EudraCT Number:2011-005452-34
    Sponsor's Protocol Code Number:SPD489-406
    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:2013-04-05
    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 number2011-005452-34
    A.3Full title of the trial
    A Phase 4, Randomised, Double-blind, Multicenter, Parallel-group, Active-controlled, Forced-dose Titration, Safety and Efficacy Study of SPD489 Compared with OROS-MPH with a Placebo Referance Arm, in Adolescents Aged 13-17 Years with Attention-deficit/Hyperactivity Disorder (ADHD)
    Studio di fase IV, randomizzato, in doppio cieco, multicentrico, per gruppi paralleli, controllato con farmaco attivo, con titolazione forzata della dose, sulla sicurezza e l’efficacia di SPD489 (VYVANSE®) rispetto a OROS-MPH (CONCERTA®) con braccio di riferimento con placebo, negli adolescenti di età compresa tra 13 e 17 anni con disturbo da deficit d'attenzione e iperattività (ADHD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to assess the safety and efficacy of SPD489 compared with Concerta with a placebo reference arm on patients aged 13-17 years with Attention-Deficit/Hyperactivity Disorder
    Uno studio per valutare la sicurezza e l’efficacia di SPD489 confronato con Concerta con braccio di controllo con placebo in pazienti di età compresa tra 13 e 17 anni con disturbo da deficit d'attenzione e iperattività
    A.4.1Sponsor's protocol code numberSPD489-406
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01552902
    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 Pharmaceutical Development 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 codeRG248EP
    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 Development LLC
    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/g milligram(s)/gram
    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 Development LLC
    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/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Development LLC
    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/g milligram(s)/gram
    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: 4
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Vyvanse
    D.2.1.1.2Name of the Marketing Authorisation holderShire Development LLC
    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/g milligram(s)/gram
    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.IMP: 5
    D.1.2 and D.1.3IMP RoleComparator
    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 Concerta
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameConcerta
    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 INNMETHYLPHENIDATE HYDROCHLORIDE
    D.3.9.1CAS number 298-59-9
    D.3.9.4EV Substance CodeSUB03254MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    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: 6
    D.1.2 and D.1.3IMP RoleComparator
    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 Concerta
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameConcerta
    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 INNMETHYLPHENIDATE HYDROCHLORIDE
    D.3.9.1CAS number 298-59-9
    D.3.9.4EV Substance CodeSUB03254MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number36
    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: 7
    D.1.2 and D.1.3IMP RoleComparator
    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 Concerta
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameConcerta
    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 INNMETHYLPHENIDATE HYDROCHLORIDE
    D.3.9.1CAS number 298-59-9
    D.3.9.4EV Substance CodeSUB03254MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number54
    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: 8
    D.1.2 and D.1.3IMP RoleComparator
    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 Concerta
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameConcerta
    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 INNMETHYLPHENIDATE HYDROCHLORIDE
    D.3.9.1CAS number 298-59-9
    D.3.9.4EV Substance CodeSUB03254MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number72
    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
    Attention-deficit/hyperactivity disorder is a psychiatric disorder characterized by developmentally inappropriate degrees of inattentiveness, impulsivity, and hyperactivity
    Il disturbo da deficit d'attenzione e iperattività è un disturbo psichiatrico caratterizzato da gradi inappropriati di sviluppo della disattenzione, impulsività, e iperattività
    E.1.1.1Medical condition in easily understood language
    Attention-deficit/hyperactivity disorder
    disturbo da deficit d'attenzione e iperattività
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10064104
    E.1.2Term ADHD
    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 primary objective is to evaluate the efficacy of VYVANSE 70mg compared with CONCERTA 72mg in adolescents (13-17 years of age, inclusive) with ADHD. The primary measure of efficacy will be the total score for the clinician-administered Attention-deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV).
    L’obiettivo primario è valutare l’efficacia di VYVANSE 70 mg rispetto a CONCERTA 72 mg negli adolescenti (da 13 a 17 anni compiuti) con ADHD. La misura primaria di efficacia sarà il punteggio totale sulla scala IV di valutazione del deficit di attenzione e iperattività (ADHD-RS-IV) somministrata dal medico.
    E.2.2Secondary objectives of the trial
    The Key Secondary objective of this study is to evaluate the efficacy of VYVANSE 70mg compared with CONCERTA 72mg, using a global clinical measure of improvement, the Clinical Global Impressions – Global Improvement (CGI-I).
    The Additional Secondary objective of this study is to evaluate the safety and tolerability of VYVANSE 70mg and CONCERTA 72mg based on the occurrence of TEAEs and specific evaluation of blood pressure and pulse.
    Valutare l’efficacia di VYVANSE 70 mg rispetto a CONCERTA 72 mg, utilizzando una scala per la misurazione del miglioramento clinico globale, la Clinical Global Impressions - Global Improvement (CGI-I). L’ulteriore obiettivo secondario di questo studio è Valutare la sicurezza e la tollerabilità di Vyvanse 70 mg e Concerta 72 mg in base alla manifestazione di eventi avversi occorsi durante il trattamento (TEAE) e valutazioni specifiche della pressione arteriosa e del battito cardiaco.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The subject will not be considered eligible for the study without meeting
    all of the inclusion criteria below. The subject cannot be randomized
    before all inclusion criteria (including test results) are confirmed.
    1. Subject must be 13-17 years of age, inclusive, at the time of consent.
    2. Subject must weigh more than 79.5lb (36kg).
    3. Subject's parent or legally authorized representative (LAR) must
    provide signature of informed consent, and there must be documentation
    of assent (if applicable) by the subject indicating that the subject is
    aware of the investigational nature of the study and the required
    procedures and restrictions in accordance with the ICH Good Clinical
    Practice (GCP) Guideline E6 (1996) and applicable regulations before
    completing any study-related procedures.
    4. Subject and parent/LAR are willing and able to comply with all of the
    testing and requirements defined in the protocol, including oversight of
    morning dosing. Specifically, the parent/LAR must be available at
    approximately 7:00AM (±2 hours) to
    dispense the dose of investigational product for the study duration.
    5. Subject, who is a female, must not have a positive serum beta human
    chorionic gonadotropin (β-HCG) pregnancy test at the Screening Visit
    (Visit -1) and must have a negative urine pregnancy test at the Baseline
    Visit (Visit 0) and agree to comply with any applicable contraceptive
    requirements of the protocol.
    6. Subject meets the DSM-IV-TR criteria for a primary diagnosis of ADHD
    based on a detailed psychiatric evaluation.
    7. Subject has an ADHD-RS-IV total score ≥28 at the Baseline Visit (Visit 0).
    8. Subject is functioning at an age-appropriate level intellectually, as
    determined by the study Investigator.
    9. Subject is able to swallow a capsule.
    10. Subject's blood pressure measurements do not exceed the 90th
    percentile for age, sex, and height at the Screening Visit (Visit -1) and
    the Baseline Visit (Visit 0)
    11. Subject is not completely satisfied with any aspect of their current
    therapy
    Il soggetto non potrà essere randomizzato prima che siano stati confermati tutti i criteri di inclusione (compresi i risultati dei test).
    1. Il soggetto deve avere un’età compresa tra 13 e 17 anni compiuti al momento del consenso.
    2. Il soggetto deve pesare più di 36,06 chili.
    3. Prima di eseguire qualsiasi procedura correlata allo studio, il genitore o il tutore legale del soggetto deve consegnare il consenso informato firmato; deve, inoltre, esistere una documentazione di assenso (se del caso) da parte del soggetto interessato, indicante che il paziente è consapevole della natura sperimentale dello studio e delle procedure e restrizioni necessarie secondo le linee guida E6 di buona pratica clinica (GCP) della Conferenza internazionale per l’armonizzazione (ICH) e le normative applicabili.
    4. Il soggetto e il suo genitore/tutore legale devono essere disposti ed in grado di rispettare l’esecuzione di tutti i test e tutti i requisiti definiti nel protocollo, compreso il controllo della somministrazione del dosaggio mattutino. Nello specifico, il genitore/tutore legale deve essere disponibile alle 7:00 del mattino (±2 ore) per somministrare la dose del farmaco sperimentale per l’intera durata dello studio.
    5. I soggetti di sesso femminile non devono risultare positivi al test di gravidanza sulla Beta HCG (gonadotropina corionica umana) nel sangue alla visita di screening (Visita -1) e devono risultare negativi al test di gravidanza sulle urine alla visita basale (Visita 0). Devono, inoltre, essere disposti a rispettare tutte le richieste in materia di contraccezione stabilite dal protocollo.
    6. Il soggetto deve soddisfare, ad un’accurata valutazione psichiatrica, i criteri per la diagnosi primaria di ADHD stabiliti nel Manuale diagnostico e statistico dei disturbi mentali - Text revision® (DSM-IV-TM®).
    7. Il soggetto ha un punteggio totale ≥28 sulla scala ADHD-RS-IV alla visita basale (Visita 0).
    8. Il soggetto ha una funzionalità intellettiva adeguata all’età secondo la valutazione dello sperimentatore dello studio.
    9. Il soggetto è in grado di ingerire capsule.
    10. La misurazione della pressione arteriosa del soggetto non supera il 90° percentile per età, sesso e altezza (in base ai valori percentili di pressione arteriosa per età e peso [per ragazzi e ragazze]) alla visita di screening (Visita -1) e alla visita basale (Visita 0).
    11. Il soggetto non è completamente soddisfatto circa alcuni aspetti dell’attuale terapia.
    E.4Principal exclusion criteria
    Subjects are excluded from the study, if any of the following criteria are met at the Screening
    Visit (Visit -1) or at the Baseline Visit (Visit 0).

    The complete list of exclusion criteria are available in Section 4.2 of the Protocol

    1. Subject has a current, controlled (with medications prohibited in this study) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any significant comorbid Axis II disorder or significant Axis I disorder (such as
    post-traumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, depressive or anxiety disorder) or other symptomatic manifestations that, in the opinion of the examining clinician, will contraindicate treatment with VYVANSE or CONCERTA or confound efficacy or safety assessments. Comorbid psychiatric diagnoses will be established with the Screening Visit (Visit -1) interview of the Kiddie–Schedule for Affective Disorders and Schizophrenia for School age Children–Present and Lifetime Version–Diagnostic Interview (K-SADS-PL) and additional modules if warranted by the results of the initial interview. Subjects may continue participation in a behavioral modification program during the study as long as they have been participating in the program for at least 1 month at the time of the Baseline Visit (Visit 0).
    2. Subject meets DSM-IV-TR diagnosis of conduct disorder. Oppositional defiant disorder is not exclusionary.
    3. 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.
    4. Subject is underweight based on Centers for Disease Control and Prevention (CDC) body mass index (BMI)-for-age sex-specific values at the Screening Visit (Visit -1). Underweight is defined as a BMI <3rd percentile.
    5. Subject is significantly overweight based on CDC BMI-for-age sex-specific values at the Screening Visit (Visit -1). Significantly overweight is defined as a BMI >97th percentile for this study.
    6. Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition that might confound the results of safety assessments conducted in the study or that might increase risk to the subject. Similarly, the 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. The additional conditions would include any significant illness or unstable medical condition
    that could lead to difficulty complying with the protocol. Mild, stable asthma is not exclusionary.
    7. Subject has a history of seizures (other than infantile febrile seizures), a chronic or current tic disorder, or a current diagnosis and/or a known family history of Tourette’s Disorder. Subject has a history of tics that are judged by the Investigator to be exclusionary.
    8. Subject has a 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
    him/her at increased vulnerability to the sympathomimetic effects of a stimulant
    medication.
    9. Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
    10. Subject has any clinically significant ECG or clinically significant laboratory
    abnormality at the Screening Visit (Visit -1).
    11. Subject has current abnormal thyroid function, defined as abnormal thyroid stimulating
    hormone (TSH) and thyroxine (T4) at the Screening Visit (Visit -1). Treatment with a
    stable dose of thyroid medication for at least 3 months is permitted.
    12. Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or to
    any excipients in the investigational product.
    13. Subject has a documented allergy, hypersensitivity, or intolerance to MPH or to any
    excipients in the reference product.
    14. Subject has failed to respond, based on Investigator judgment, to an adequate course(s)
    (dose and duration) of MPH therapy.
    Sono esclusi dallo studio i soggetti che soddisfano anche uno solo dei criteri seguenti alla visita di screening (V-1) o alla visita basale (V0), in caso di rivalutazione.
    1. Il soggetto presenta una diagnosi di comorbidità con un altro disturbo psichiatrico controllato (con farmaci non consentiti dallo studio) o non controllato, con sintomi significativi, quali qualsiasi disturbo significativo in asse II o in asse I (per esempio disturbo post-traumatico da stress, psicosi, disturbo bipolare, disturbo pervasivo dello sviluppo, disturbo ossessivo-compulsivo grave, depressione o disturbi d’ansia) o altre manifestazioni sintomatiche che, secondo il parere del medico che conduce l’esame, possano costituire una controindicazione alla terapia con VYVANSE o CONCERTA, oppure confonderne l’efficacia o le valutazioni sulla sicurezza. La diagnosi di comorbidità psichiatra sarà stabilita alla visita di screening (Visita -1) mediante l’intervista diagnostica per la valutazione dei disturbi psicopatologici in bambini e adolescenti K-SADS-PL, così come tramite ulteriori moduli, nel caso in cui ciò sia giustificato dai risultati dell’intervista iniziale. I soggetti possono proseguire la partecipazione a programmi per la modifica del comportamento durante lo studio se vi stanno già partecipando da almeno un mese al momento della visita basale (V0).
    2.Il soggetto soddisfa i criteri diagnostici del DSM-IV-TR per il disturbo della condotta. Il disturbo oppositivo provocatorio non costituisce un criterio di esclusione.
    3.Il soggetto è considerato a rischio di suicidio secondo l’opinione dello sperimentatore, ha già tentato il suicidio o evidenzia, allo stato attuale, ideazione suicidaria attiva. I soggetti con ideazione suicidaria passiva intermittente non devono necessariamente essere esclusi dallo studio; l’eventuale esclusione dipenderà dalla valutazione dello sperimentatore.
    4.Alla visita di screening (Visita -1) il soggetto risulta sottopeso secondo i valori specifici per età e sesso dell’indice di massa corporea (IMC) dei centri per la prevenzione e il controllo delle malattie (CDC). Si definisce sottopeso un IMC < 3° percentile.
    5.Alla visita di screening (V-1) il soggetto risulta in significativo sovrappeso secondo i valori specifici per età e sesso dell’indice di massa corporea (IMC) dei centri per la prevenzione e il controllo delle malattie (CDC). In questo studio, il sovrappeso è considerato significativo quando IMC > 97° percentile.
    6.Il soggetto presenta malattie croniche o acute concomitanti (per esempio, rinite allergica severa o un processo infettivo che richiede l’assunzione di antibiotici), disabilità o altre condizioni che potrebbero confondere i risultati sulle valutazioni della sicurezza condotte durante lo studio o che potrebbero aumentare il rischio per il paziente. Allo stesso modo, il soggetto sarà escluso se presenta ulteriori condizioni che, secondo il parere dello sperimentatore, potrebbero impedirgli di portare a termine lo studio o nel caso in cui partecipare a questa ricerca non sia nel miglior interesse del paziente. Tali ulteriori condizioni potrebbero comprendere una qualsiasi malattia significativa o condizioni mediche instabili che potrebbero rendere difficoltoso rispettare il protocollo. La presenza di asma lieve e stabile non costituisce criterio di esclusione.
    7.Il soggetto ha una storia di crisi convulsive (diverse da crisi convulsive febbrili infantili), un disturbo da tic cronico o corrente oppure gli è stata diagnosticata o ha una storia familiare nota di sindrome di Tourette. Il soggetto ha una storia di tic che lo sperimentatore considera tale da costituire criterio di esclusione.
    8.Il soggetto ha una storia nota di disturbo cardiovascolare sintomatico, arteriosclerosi avanzata, anomalie strutturali del cuore, cardiomiopatia, gravi anomalie del ritmo cardiaco, coronaropatia o altri disturbi cardiaci gravi che potrebbero esporlo a maggiore vulnerabilità agli effetti simpaticomimetici dei farmaci stimolanti.
    9.Il soggetto ha una storia familiare nota di morte cardiaca improvvisa o aritmia ventricolare.
    10.Alla visita di screening (V-1), il soggetto presenta anomalie clinicamente significative all’elettrocardiogramma (ECG) o agli esami di laboratorio.
    11.Il soggetto presenta anomalie della funzionalità tiroidea, definite come anomalie dell’ormone tireostimolante e della tirosina, alla visita di Screening (Visita -1). È consentito il trattamento con una dose stabile di farmaci per la tiroide da almeno 3 mesi.
    12.Il soggetto presenta allergia, ipersensibilità o intolleranza documentate alle anfetamine o a uno qualsiasi degli eccipienti contenuti nel prodotto sperimentale.
    13.Il soggetto presenta allergia, ipersensibilità o intolleranza documentate all’MPH o a uno qualsiasi degli eccipienti contenuti nel prodotto di riferimento.
    14. Il soggetto non ha risposto, in base al giudizio dello sperimentatore, a uno o più cicli adeguati (quanto a dose e durata) di terapia con MPH.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective is to evaluate the efficacy of VYVANSE 70mg compared with CONCERTA 72mg in adolescents (13-17 years of age, inclusive) with ADHD. The primary measure of efficacy will be the total score for the clinician-administered
    Attention-deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV).
    L’obiettivo primario è valutare l’efficacia di VYVANSE 70 mg rispetto a CONCERTA 72 mg negli adolescenti (da 13 a 17 anni compiuti) con ADHD. La misura primaria di efficacia sarà il punteggio totale sulla scala IV di valutazione del deficit di attenzione e iperattività (ADHD-RS-IV) somministrata dal medico.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The change from baseline for the ADHD-RS-IV total score at Visit 6 (Week 6), where Baseline is defined as the last valid
    ADHD-RS-IV total score assessment prior to the first dose.
    Cambio dal basale del punteggio totale ADHD-RS-IV alla visita 6 (settimana 6), dove il basale è definito come l’ultima valutazione valida del punteggio totale ADHD-RS-IV prima della prima dose.
    E.5.2Secondary end point(s)
    Key secondary:
    To evaluate the efficacy of VYVANSE 70mg compared with CONCERTA 72mg, using a global clinical measure of
    improvement, the Clinical Global Impressions – Global Improvement (CGI-I).
    Additional Secondery endpoints are described in the protocol
    Secondario principale: Valutare l’efficacia di VYVANSE 70 mg rispetto a CONCERTA 72 mg, utilizzando una scala per la misurazione del miglioramento clinico globale, la Clinical Global Impressions - Global Improvement (CGI-I).
    Ulteriori endpoint secondari sono descritti nel protocollo
    E.5.2.1Timepoint(s) of evaluation of this end point
    Key Secondary:
    The proportion of subjects with an "improved" CGI-I measurement from baseline visit (week 0) CGI-Severity of illness to Visit 6 (week 6).
    Additional secondary endpoints are described in the protocol
    Secondario principale: la proporzione di soggetti con un “miglioramento” della misurazione CGI-I dal basale (settimana 0) al CGI-Severity of illness della Visita 6 (settimana 6).
    Ulteriori endpoint secondari sono descritti nel protocollo.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned11
    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
    Canada
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months1
    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 months1
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 542
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 542
    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 No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects under age incapable of giving consent personally. Subject’s parent or legally authorized representative (LAR) must provide informed consent. Subject's assent must be documented (if applicable)
    Soggetti sotto l’età incapaci di dare personalmente il loro consenso. I genitori del soggetto o il rappresentante legale autorizzato devono dare il consenso informato. L’assenso del soggetto deve essere documentato ( se applicabile)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 138
    F.4.2.2In the whole clinical trial 542
    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)
    Investigator will provide standard of care to Subjects
    Lo sperimentatore fornirà la terapia standard ai soggetti
    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 Decision2013-07-12
    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 StatusPrematurely Ended
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