Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42516   clinical trials with a EudraCT protocol, of which   7000   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2011-004668-31
    Sponsor's Protocol Code Number:SPD503-318
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-02
    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 number2011-004668-31
    A.3Full title of the trial
    A Phase 3, Open-label, Multicentre Study to Provide Access to Guanfacine Hydrochloride Extended-release for European Subjects with Attention-deficit/Hyperactivity Disorder (ADHD) who participated in study SPD503-315 or SPD503-316
    Studio multicentrico, in aperto, di fase 3, per consentire l'accesso alla guanfacina cloridrato a rilascio prolungato a soggetti europei con disturbi di deficit d'™attenzione e iperattivita' (ADHD) che hanno partecipato allo studio SPD503-315 o SPD503-316
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open-label extention study with Guanfacine Hydrochloride in Subjects with Attention-deficit/Hyperactivity Disorder (ADHD)
    Studio in aperto, di estensione con guanfacina cloridrato a rilascio prolungato in soggetti disturbi di deficit d’attenzione e iperattivita' (ADHD)
    A.4.1Sponsor's protocol code numberSPD503-318
    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 PHARMACEUTICALS LTD
    B.1.3.4CountryUnited Kingdom
    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 Pharmaceutical Development Ltd.
    B.4.2CountryUnited Kingdom
    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 pointClinical Progress Leadership
    B.5.3 Address:
    B.5.3.1Street AddressHampshire International Business Park
    B.5.3.2Town/ cityBaingstoke
    B.5.3.3Post codeRG24 8EP
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 (0) 1256 894000
    B.5.5Fax number+44 (0) 1256 894707
    B.5.6E-mailcpmailbox@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 Intuniv
    D.2.1.1.2Name of the Marketing Authorisation holderShire Development Inc., USA
    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.3.4Pharmaceutical form Prolonged-release tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGUANFACINE HYDROCHLORIDE
    D.3.9.1CAS number 29110-48-3
    D.3.9.2Current sponsor codeSPD503
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB02427MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Intuniv
    D.2.1.1.2Name of the Marketing Authorisation holderShire Development Inc., USA
    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.3.4Pharmaceutical form Prolonged-release tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGUANFACINE HYDROCHLORIDE
    D.3.9.1CAS number 29110-48-3
    D.3.9.2Current sponsor codeSPD503
    D.3.9.4EV Substance CodeSUB02427MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Intuniv
    D.2.1.1.2Name of the Marketing Authorisation holderShire Development Inc., USA
    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.3.4Pharmaceutical form Prolonged-release tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGUANFACINE HYDROCHLORIDE
    D.3.9.1CAS number 29110-48-3
    D.3.9.2Current sponsor codeSPD503
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB02427MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 Intuniv
    D.2.1.1.2Name of the Marketing Authorisation holderShire Development Inc., USA
    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.3.4Pharmaceutical form Prolonged-release tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGUANFACINE HYDROCHLORIDE
    D.3.9.1CAS number 29110-48-3
    D.3.9.2Current sponsor codeSPD503
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB02427MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Attention deficit/hypercativity disorder
    Disturbi di deficit d’attenzione e iperattività
    E.1.1.1Medical condition in easily understood language
    ADHD
    ADHD
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10064104
    E.1.2Term ADHD
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to provide access to SPD503 for subjects following their participation in SPD503-315 or SPD503-316, for up to 2 years or where applicable, until the outcome of a Marketing Application, whichever comes first.
    L’obiettivo primario dello studio è di consentire l’accesso al farmaco SPD503 ai soggetti che hanno partecipato agli studi SPD503-315 o SPD503-316 per almeno 2 anni o, laddove applicabile, fino all’autorizzazione all’immissione in commercio, se rilasciata prima dei due anni.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    • To evaluate the long-term safety and tolerability of SPD503
    • To assess the maintenance of efficacy of SPD503 achieved in antecedent studies.
    Gli obiettivi secondari di questo studio sono:
    • valutare la sicurezza e la tollerabilità a lungo termine di SPD503;
    • valutare il mantenimento dell’efficacia di SPD503 definita negli studi precedenti.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For subjects enrolling from antecedent Study SPD503-315:
    Subjects will be eligible for Study SPD503-318 if they met the response criteria for entry into Phase 2 of Study SPD503-315, were randomised, and either completed Phase 2 or withdrew early because the protocol-defined treatment failure criteria were met.
    For subjects enrolling from antecedent Study SPD503-316:
    Children aged 6-12 years, upon entry to SPD503-316, regardless of treatment group, must have completed 10 weeks of double-blind treatment in Study SPD503-316, reached Visit 15/Final, and completed the 2 week dose taper.
    Adolescents aged 13 years and older, regardless of treatment group, must have completed 13 weeks of double blind treatment in Study SPD503-316, reached Visit 15/Final, and completed the 2-week dose taper.
    For all subjects:
    1. Subjects where Study SPD503-318 was not available at the time of their final visit in the antecedent study (SPD503-315 or SPD503-316), may still be screened unless they are well-controlled on another ADHD medication with acceptable tolerability and the parent(s)/caregiver(s) is satisfied with their current ADHD medication.
    2. Subject satisfied all entry criteria for the antecedent study (SPD503 315 or SPD503-316).
    3. Subject who is a female of child-bearing potential (FOCP), defined as >9 years of age or <9 years of age and is post-menarchal, must have a negative serum beta human chorionic gonadotropin (hCG) pregnancy test at the Screening Visit (Visit 1) and a negative urine pregnancy test at the Baseline Visit (Visit 2) and agree to comply with any applicable contraceptive requirements of the protocol.
    4. Subject’s parent(s) or legally authorised representative(s) (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 International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations, before completing any study-related procedures.
    5. Subject and parent(s)/LAR(s) are willing, able, and likely to fully comply with all the testing and requirements defined in this protocol, including oversight of dosing. Specifically, the parent(s)/LAR(s) must be available upon awakening, to dispense the dose of investigational product for the duration of the study.
    6. Subject has a supine and standing blood pressure (BP) measurement within the 95th percentile for age, sex, and height.
    7. Subject is functioning at an age-appropriate level intellectually, as deemed by the Investigator.
    8. Subject is able to swallow intact tablets.
    Per i soggetti arruolati dal precedente studio SPD503-315:
    Isoggetti risulteranno idonei allo studio SPD503-318 se avevano soddisfatto i criteri per l’entrata nella fase 2 dello studio SPD503-315, se erano stati randomizzati e hanno completato la fase 2 o si sono ritirati in anticipo, perché i criteri di fallimento del trattamento, come definiti nel protocollo, erano stati soddisfatti.
    Per i soggetti arruolati dal precedente studio SPD503-316:
    i bambini di età compresa tra i 6 e i 12 anni, al momento dell’ammissione allo studio SPD503-316, a prescindere dal gruppo di trattamento, dovranno aver completato 10 settimane di trattamento, in doppio cieco, dello studio SPD503-316, raggiunto la Visita 15/finale e completato le 2 settimane di riduzione della dose.
    Gli adolescenti di 13 anni o più, a prescindere dal gruppo di trattamento, dovranno aver completato 13 settimane di trattamento, in doppio cieco, dello studio SPD503-318, raggiunto la Visita 15/finale e completato le 2 settimane di riduzione della dose.
    Per tutti i soggetti:
    1. i soggetti per i quali lo studio SPD503-318 non era disponibile al momento della loro ultima visita dello studio precedente (SPD503-315 o SPD503-316), possono ancora essere sottoposti a screening, a meno che non siano già ben controllati con un altro farmaco per l’ADHD con tollerabilità accettabile e il genitore/assistente non sia soddisfatto del farmaco per l’ADHD in uso;
    2. il soggetto ha soddisfatto tutti i criteri di inclusione per lo studio precedente (SPD503-315 o SPD503-316);
    3. il soggetto di sesso femminile in età fertile (FOCP, Female of child-bearing potential), definita come avente un’età &gt; di 9 anni o un’età &lt; 9 anni, in post-menarca, deve risultare negativo al test di gravidanza della gonadotropica corionica umana beta (hCG, Human Chorionic Gonadotropin) sierica durante la visita di screening (Visita 1) e negativo al test di gravidanza delle urine al basale (Visita 2) e acconsentire ad adottare le eventuali misure contraccettive previste dal protocollo;
    4. il genitore o rappresentante legalmente autorizzato (LAR, Legally Authorised Representative) del soggetto deve apporre la propria firma sul modulo relativo al consenso informato, inoltre deve essere fornito un documento di assenso (laddove possibile) del soggetto in questione attestante la consapevolezza da parte del soggetto circa la natura sperimentale dello studio e le procedure e restrizioni necessarie in conformità a quanto stabilito dalle linee guida E6 della Conferenza internazionale per l’armonizzazione (ICH, International Conference Harmonisation) della Buona prassi clinica (GCP, Good Clinical Practice) e con i regolamenti vigenti, prima di avviare una qualsivoglia procedura riferita allo studio;
    5. il soggetto e il genitore/LAR comprendono, desiderano e sono in grado di rispettare totalmente i requisiti e gli esami definiti nel presente protocollo, compresa la supervisione del dosaggio. In particolar modo, al risveglio, ilgenitore/LAR deve essere disponibile a somministrare la dose del farmaco sperimentale per la durata dello studio;
    6. in posizione supina ed eretta il soggetto ha una pressione arteriosa (PA) che rientra nel 95° percentile in base all’età, al sesso e all’altezza;
    7. il soggetto deve avere un’attività intellettuale adeguata alla sua età, in base al giudizio dello sperimentatore;
    8. il soggetto è in grado di ingerire compresse intere.
    E.4Principal exclusion criteria
    Exclusion Criteria:
    1. Subject has any current, controlled (requiring a prohibited medication or behavioural modification program) or uncontrolled, co-morbid psychiatric diagnosis (except oppositional defiant disorder), including any severe comorbid Axis II disorders or severe Axis I disorders such as post traumatic stress disorder, bipolar illness, psychosis, pervasive developmental disorder, obsessive-compulsive disorder, substance abuse disorder, or other symptomatic manifestations or lifetime history of bipolar illness, psychosis or conduct disorder that, in the opinion of the Investigator, contraindicate treatment with SPD503 or confound efficacy or safety assessments. The Kiddie Schedule for Affective Disorders and Schizophrenia – Present and Lifetime version (K-SADS-PL) rating from the antecedent study should be reviewed to confirm diagnosis, if necessary.
    2. Subject who early terminated from Study SPD503-315 or Study SPD503-316 for protocol non-adherence, subject non-compliance, an AE, SAE, or withdrawal by subject.
    3. Subject experienced any clinically significant AE in their prior SPD503 study (SPD503-315 or SPD503 316) that, in the opinion of the Investigator, would preclude exposure to SPD503.
    4. Clinically important abnormality on urine drug and/or alcohol screen at the Screening Visit (Visit 1).
    5. Subject has taken any investigational product as follows: last dose of investigational product in Study SPD503-315 within 7 days prior to the Baseline Visit (Visit 2); investigational product in Study SPD503 316 within 30 days prior to the Baseline Visit (Visit 2); any other investigational product within 30 days prior to the Baseline Visit (Visit 2) or any other ADHD medication within 30 days prior to Baseline Visit (Visit 2).
    6. Subject is significantly overweight based on Center for Disease Control and Prevention Body Mass Index (BMI)-for-age sex-specific charts at the Screening Visit (Visit 1). Significantly overweight is defined as a BMI >95th percentile.
    7. Children aged 6 12 years with a body weight of less than 25.0kg or adolescents aged 13 years and older with a body weight of less than 34.0kg at the Screening Visit (Visit 1).
    8. Subject has any condition or illness including clinically significant abnormal laboratory values at the Screening Visit (Visit 1) which, in the opinion of the Investigator, represents an inappropriate risk to the subject and/or could confound the interpretation of the study.
    9. Subject is currently considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator.
    10. Subject has clinically significant ECG findings, as judged by the Investigator with consideration of the central ECG laboratory’s interpretation, at the Baseline Visit (Visit 2).
    11. Subject has a known or suspected allergy, hypersensitivity, or clinically significant intolerance to guanfacine hydrochloride, or any components found in SPD503.
    12. Subject has a history of alcohol or other substance abuse or dependence, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR; with the exception of nicotine) within the last 6 months.
    13. Subject has a history of a seizure disorder (other than a single childhood febrile seizure occurring before the age of 3 years) or the presence of a serious tic disorder including Tourette’s syndrome.
    1. Soggetto con una qualsiasi diagnosi psichiatrica comorbida controllata (che richiede un farmaco proibito o un programma di modificazione del comportamento) o non controllata (tranne il disturbo oppositivo provocatorio), compresi disturbi comorbidi gravi dell’Asse II o disturbi gravi dell’Asse I, quali disturbo post-traumatico da stress, sindrome bipolare, psicosi, disturbo pervasivo dello sviluppo, disturbo ossessivo-compulsivo, disturbo da abuso di sostanze o altre manifestazioni sintomatiche o anamnesi di malattia bipolare, psicosi o disturbi della condotta, che secondo lo sperimentatore, controindicano il trattamento con SPD503 o confondono le valutazioni sull’efficacia e sulla sicurezza. Se necessario, per confermare la diagnosi si deve esaminare il punteggio K-SADS-PL (Kiddie Schedule for Affective Disorders and Schizophrenia – Present and Lifetime version) ottenuto nello studio precedente.
    2. Soggetto che ha terminato in anticipo lo studio SPD503-315 o lo studio SPD503-316, per non aderenza al protocollo, non conformità del soggetto, un EA, un EAG o il ritiro del soggetto.
    3. Soggetto che ha accusato un EA clinicamente significativo nello studio precedente su SPD503 (SPD503-315 o SPD503-316), che secondo il parere dello sperimentatore precluderebbe l’esposizione al farmaco SPD503.
    4. Soggetto con anomalie clinicamente importanti al test di droghe e alcol delle urine durante la visita di screening (Visita 1).
    5. Soggetto che ha assunto un qualsiasi faramco sperimentale con le seguenti modalità: ultima dose del faramco sperimentale dello studio SPD503-315 nei 7 giorni prima della visita basale (Visita 2); farmcao sperimentale dello studio SPD503-316 nei 30 giorni prima della visita basale (Visita 2); un qualsiasi farmaco sperimentale nei 30 giorni prima della visita basale (Visita 2) o un qualsiasi altro farmaco per l’ADHD nei 30 giorni prima della visita basale (Visita 2).
    6. Soggetto che durante la visita di screening (Visita 1) risulta in notevole sovrappeso rispetto alle tabelle di rapporto età/sesso/indice di massa corporea (BMI, Body Mass Index) del Centro per il controllo delle malattie e la prevenzione. Per “notevole sovrappeso” si intende un BMI &gt; 95° percentile.
    7. Bambini di età compresa tra 6 e 12 anni, con peso inferiore a 25,0 kg o adolescenti di età compresa tra 13 anni o più, con peso inferiore a 34,0 kg durante la visita di screening (Visita 1).
    8. Soggetto che presenta condizioni o malattie, compresi valori anomali degli esami di laboratorio clinicamente significativi, durante la visita di screening (Visita 1), che, secondo lo sperimentatore, rappresentano un rischio improprio per il soggetto e/o possono confondere l’interpretazione dello studio.
    9. Soggetto che lo sperimentatore considera al momento un potenziale suicida, che ha tentato il suicidio in precedenza o che presenta un’anamnesi di questo tipo o che attualmente manifesta pensieri suicidi attivi. I soggetti con pensieri suicidi passivi intermittenti non sono essere necessariamente esclusi in base alla valutazione dello sperimentatore.
    10. Soggetto con risultati ECG clinicamente significativi, valutati dallo sperimentatore considerando l’interpretazione del laboratorio ECG centrale, alla visita basale (Visita 2).
    11. Soggetto con allergia, ipersensibilità o intolleranza clinicamente significativa note o sospette alla guanfacina cloridrato o a qualsiasi componente del farmaco SPD503.
    12. Soggetto con un’anamnesi di abuso o dipendenza da alcol o altre sostanze negli ultimi 6 mesi, ad eccezione della nicotina, in base a quanto definito nel DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision).
    13. Soggetto con un’anamnesi di convulsioni (diverse dalle singole convulsioni febbrili infantili che si possono verificare durante i primi 3 anni di età) o con gravi tic, compresa la sindrome di Tour
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints of this study are the long-term safety of SPD503 as follows:
    • Occurrence of TEAEs
    • Specific evaluation of BP and pulse
    • ECG results
    • C-SSRS
    • Effects on growth will be assessed.
    Gli endpoint primari di questo studio riguardano la sicurezza a lungo termine di SPD503, ossia:
    • presenza di TEAE;
    • valutazione specifica della PA e del battito cardiaco;
    • risultati ECG;
    • C-SSRS;
    • valutazione degli effetti sulla crescita.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 2 anni
    Fino a due anni
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints of the study are listed below:
    • The change from baseline in ADHD-RS-IV total score and the hyperactivity/impulsivity and inattention subscale scores at each of Visits 3 19. Baseline will be defined in 2 ways; firstly as the Baseline Visit from the antecedent study, and secondly as Visit 2 from this study.
    • The CGI-S at each of Visits 2 19
    Gli endpoint secondari dello studio sono elencati di seguito:
    • variazione rispetto al basale del punteggio totale della scala ADHD-RS-IV e dei punteggi delle sottoscale di iperattività/impulsività e disattenzione a ognuna delle visite 3-19. Il basale sarà definito in due modi: innanzitutto, come visita basale dello studio precedente e, secondariamente, come Visita 2 del presente studio;
    • la scala CGI a ognuna delle visite 2-19.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 2 years
    Fino a due anni
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    This study has been designed to provide up to 2 years access to SPD503
    Questo studio è stato ideato per consentire l’accesso per altri 2 anni a SPD503
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA82
    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
    Turkey
    Ukraine
    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 years0
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months36
    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: 245
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 180
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 65
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 4
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-03-02. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Minors
    Minori
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state55
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 199
    F.4.2.2In the whole clinical trial 249
    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)
    There are no planned additional treatments/care for the subjects after the conclusion of their participation in the trial.
    Non c'è un programma per il trattamento/assistenza per i soggetti al termine della loro partecipazione
    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 Decision2011-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-09-15
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA