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    Summary
    EudraCT Number:2011-002221-21
    Sponsor's Protocol Code Number:SPD503-312
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2011-08-30
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2011-002221-21
    A.3Full title of the trial
    A Phase 3, Double-blind, Randomized, Multi-center, Placebo controlled, Dose-optimization Study Evaluating the Safety, Efficacy, and Tolerability of Once daily Dosing with Extended-release Guanfacine Hydrochloride in Adolescents Aged 13-17 years Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess the safety and efficacy of Guanfacine hydrochloride in adolescents aged 13-17 with Attention Deficit/Hyperactivity Disorder.
    A.4.1Sponsor's protocol code numberSPD503-312
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/186/2010
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorShire Development Inc
    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 Inc
    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 pointClinical Programs Leadership
    B.5.3 Address:
    B.5.3.1Street AddressHampshire International Business Park
    B.5.3.2Town/ cityBasingstoke
    B.5.3.3Post codeRG24 8EP
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number441256894000
    B.5.5Fax number441256894707
    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
    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 nameGuanfacine Hydrochloride
    D.3.2Product code SPD503
    D.3.4Pharmaceutical form Prolonged-release tablet
    D.3.4.1Specific paediatric formulation Yes
    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 Hydrocloride
    D.3.9.1CAS number 29110-48-3
    D.3.9.2Current sponsor codeSPD503
    D.3.9.3Other descriptive nameN-amidino-2-(2,6-dichlorophenyl) acetamide monohydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 nameN-amidino-2-(2,6-dichlorophenyl)acetamide monohydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 nameN-amidino-2-(2,6-dichlorophenyl)acetamide monohydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGuanfacine Hydrocloride
    D.3.9.1CAS number 29110-48-3
    D.3.9.2Current sponsor codeSPD503
    D.3.9.3Other descriptive nameN-amidino-2-(2,6-dichlorophenyl)acetamide monohydrochloride
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 4
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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 (ADHD)
    E.1.1.1Medical condition in easily understood language
    Attention-Deficit/Hyperactivity Disorder (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 14.0
    E.1.2Level LLT
    E.1.2Classification code 10068451
    E.1.2Term ADHD, combined type
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10068453
    E.1.2Term ADHD, predominantly inattentive type
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10068452
    E.1.2Term ADHD, predominantly hyperactive-impulsive type
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    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
    To assess the efficacy of once daily dosing with optimized SPD503 compared with placebo in the treatment of adolescents aged 13-17 years with a diagnosis of ADHD as measured by the Attention deficit/Hyperactivity Disorder Rating Scale (ADHD-RS-IV).
    E.2.2Secondary objectives of the trial
    1. To evaluate the effect on the Clinical Global Impressions – Severity of
    Illness (CGI-S) Scale.
    2. To evaluate the effect on the Clinical Global Impressions – Global
    Improvement (CGI-I) Scale.
    3. To evaluate the changes in functional impairment as measured by the Weiss Functional Impairment Rating Scale-Parent (WFIRS-P).
    4. To evaluate the safety and tolerability based on treatment-emergent adverse events (TEAEs), clinical laboratory results, electrocardiogram (ECG) results, vital signs, and results from the Brief Psychiatric Rating Scale for Children (BPRS-C), a structured side-effect questionnaire (SSEQ), and the Columbia Suicide Severity Rating Scale (C-SSRS).
    5. To evaluate the tolerability based on the Pediatric Daytime Sleepiness Scale (PDSS).
    6. To develop a population pharmacokinetic model of
    SPD503.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, aged 13-17 years at the time of consent/assent (screening only).
    2. Subject’s parent or legally authorized representative (LAR) must provide signature of informed consent, and there must be documentation of assent 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) Guidance E6 (1996) and applicable regulations before completing any study-related procedures at screening.
    3. Subject meets Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD, combined subtype, hyperactive/impulsive subtype, or inattentive sub-type based on a detailed psychiatric evaluation using the Kiddie Schedule for Affective Disorders and Schizophrenia – Present and Lifetime version (K SADS PL) at screening (re-confirm if baseline visit is >35 days from screening).
    4. Subject has a minimum ADHD-RS-IV total score of 32 at baseline.
    5. Subject has a minimum CGI-S score of 4 at baseline.
    6. Subject is functioning at an age-appropriate level intellectually, as deemed by the Investigator.
    7. Subject and parent/LAR understand, are able, willing and likely to fully comply with the study procedures and restrictions defined in this protocol.
    8. Subject is able to swallow intact tablets.
    9. All females must have a negative serum beta human Chorionic Gonadotropin (hCG) pregnancy test at screening and a negative urine pregnancy test at baseline. Female subjects must abstain from sexual activity that could result in pregnancy or agree to use acceptable methods of contraception.
    10. Subject has a supine and standing blood pressure (BP) measurement within the 95th percentile for age, gender, and height.
    E.4Principal exclusion criteria
    1. Subject has a current, controlled (requiring a prohibited medication or behavioral modification program) or uncontrolled, comorbid psychiatric diagnosis except Oppositional Defiant Disorder (ODD), including any severe comorbid Axis II disorders or severe Axis I disorders such as post traumatic stress disorder (PTSD), bipolar illness, psychosis, pervasive developmental disorder, obsessive-compulsive disorder (OCD), 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 SPD503 treatment or confound efficacy or safety assessments.
    2. Subject has any condition or illness including clinically significant abnormal screening laboratory values which, in the opinion of the Investigator, represents an inappropriate risk to the subject and/or could confound the interpretation of the study.
    3. Subject has a known history or presence of structural cardiac abnormalities, serious heart rhythm abnormalities, syncope, cardiac conduction problems (e.g., clinically significant heart block), exercise-related cardiac events including syncope and pre-syncope, or clinically significant bradycardia.
    4. Subject has clinically significant ECG findings as judged by the Investigator with consideration of the central ECG interpretation.
    5. Subject with orthostatic hypotension or a known history of controlled or uncontrolled hypertension.
    6. Current use of any prohibited medication, including herbal supplements that affect blood pressure, heart rate, have central nervous system (CNS) effects, or affect cognitive performance, such as sedating antihistamines and decongestant sympathomimetics (inhaled bronchodilators are permitted) or a history of chronic use of sedating medications (i.e., antihistamines) at baseline.
    7. Subject has a history of alcohol or other substance abuse or dependence, as defined by DSM IV-TR (with the exception of nicotine) within the last six months.
    8. Subject has taken another investigational product within 30 days prior to baseline.
    9. Subject is significantly overweight based on Center for Disease Control and Prevention Body Mass Index (BMI)-for-age gender specific charts at screening. Significantly overweight is defined as a BMI >95th percentile for this study.
    10. Body weight of less than 34.0kg or greater than 91.0kg at screening.
    11. Subject has a known or suspected allergy, hypersensitivity, or clinically significant intolerance to guanfacine hydrochloride or any components found in SPD503.
    12. Clinically important abnormality on urine drug and/or alcohol screen (excluding the subject’s current ADHD stimulant if applicable).
    13. Subject is female and is pregnant or currently lactating.
    14. Subject failed screening or was previously enrolled in this study.
    15. 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 suicide ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator.
    16. History of failure to respond to an adequate trial (consisting of an appropriate dose and adequate duration of therapy), in the opinion of the Investigator, of an α2-agonist for the treatment of ADHD.
    17. 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).
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the change from baseline (Day 0) for the ADHD-RS-IV total score at Week 13 (Visit 13).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 13
    E.5.2Secondary end point(s)
    The secondary endpoints are ADHD-RS-IV hyperactivity/impulsivity and inattentiveness subscale scores, CGI-S scores, CGI-I scores, and WFIRS P results.
    Safety endpoints include results of vital signs, ECG results, TEAEs, clinical laboratory results, PDSS, BPRS-C, SSEQ, and C-SSRS results.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 13
    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 Yes
    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 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 No
    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 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 trial is defined as the safety follow-up visit i.e. 7 days post last dose of IMP, for the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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: 280
    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: 280
    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 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 2011-08-30. 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
    Due to population age of trial subjects, adults/parental consent forms have been generated
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 280
    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 is no planned additional care for subjects after the trial
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Not applicable
    G.4.3.4Network Country United States
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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