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    Summary
    EudraCT Number:2006-000304-16
    Sponsor's Protocol Code Number:B4Z-UT-S017
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2021-12-02
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2006-000304-16
    A.3Full title of the trial
    A Randomized, Double-blind Comparison of Atomoxetine Hydrochloride and Placebo for Symptoms of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents With Autism Spectrum Disorder.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparing effectiveness of Atomoxetine Hydrochloride and Placebo in reducing ADHD (Attention Deficit/Hyperactivity Disorder) symptoms in children and adolescents with ASD (Autism Spectrum Disorder).
    A.4.1Sponsor's protocol code numberB4Z-UT-S017
    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 SponsorEli Lilly and Company
    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 supportEli Lilly and Company
    B.4.2CountryUnited Arab Emirates
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center, DC 1526
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 Strattera
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly and Company
    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 nameAtomoxetine Hydrochloride
    D.3.2Product code LY139603
    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 INNAtomoxetine hydrochloride
    D.3.9.1CAS number 82248-59-7
    D.3.9.3Other descriptive nameATOMOXETINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB75495
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 1.4
    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
    E.1.1.1Medical condition in easily understood language
    Attention-Deficit/Hyperactivity Disorder
    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 23.0
    E.1.2Level LLT
    E.1.2Classification code 10003735
    E.1.2Term Attention deficit-hyperactivity disorder
    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 of this study is to test the hypothesis that atomoxetine given at a dose up to 1.2 mg/kg/day (once daily) for 8 weeks is superior to placebo in the treatment of symptoms of Attention-Deficit/Hyperactivity Disorder (ADI-ID) in in-and outpatients aged 6 through 17 years with a diagnosis of Autism Spectrum Disorder (ASD).
    E.2.2Secondary objectives of the trial
    1) To assess the efficacy of acute treatment with up to 1.2 mg/kg/day atomoxetine versus placebo for 8 weeks on symptoms of ADI-ID.
    2) To assess the efficacy of maintenance treatment with atomoxetine during open label follow-up on symptoms of ADHD.
    3) To assess the safety and tolerability of up to 1.2 mg/kg/day atomoxetine versus placebo for 8 weeks and of atomoxetine dilling open label follow up in pediatric patients with ASD and ADI-ID symptoms.
    4) To assess the effect of up to 1.2 mg/kg/day atomoxetine versus placebo for 8 weeks and of atomoxetine during open label follow up on sleeping patterns as measured by the Sleep Measures scale.
    5) To assess the effect of up to 1.2 mg/kg/day atomoxetine versus placebo for 8 weeks and of atomoxetine during open label follow up on ASD symptoms as measured by the Aberrant Behavior Checklist (ABC) and the Children's Social Behavior Questionnaire (CSBQ).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) ASD (autistic disorder or Asperger's disorder or Pervasive Developmental Disorder - Not Otherwise Specified [PDD NOS])
    2) Criteria A through D for Attention-Deficit/Hyperactivity Disorder (ADHD)
    3) At least 1.5 standard deviations above the age norm for their diagnostic subtype using published norms for the ADHD Rating Scale-IV-Parent Version
    4) Intelligence quotient (IQ) score > 60
    E.4Principal exclusion criteria
    1) weight under 20 kg
    3) patients at serious suicidal risk.
    4) Contraindication to the use of atomoxetine
    5) Patients who in the investigator's judgment are likely to need psychotropic medications apart from the drug. Patients who at any time during Study Period II are likely to begin a structured psychotherapy, likely to require hospitalization (i.e. in-patient treatment) or likely to be dismissed from in-patient treatment. Psychotherapy (including hospitalization) initiated at least 2 months prior to study participation is acceptable; however, after study participation has begun, only during Study Period III supportive or educational therapy is permitted.
    E.5 End points
    E.5.1Primary end point(s)
    ADHD Rating Scale-IV-Parent Version: Investigator Scored - Total Score
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, 8 weeks
    E.5.2Secondary end point(s)
    a) Clinical Global Impressions-ADHD-Improvement (CGI-ADHD - I) at 28 weeks.
    b) Conners' Teacher Rating Scale - Revised: Short Form (CTRS-R:S) at 28 weeks.
    c) ADHD Rating Scale-IV-Parent Version: Investigator Scored Total Score at 28 weeks.
    d) Sleep Measure Scale at 28 weeks.
    c) Aberrant Behavior Checklist (ABC) at 28 weeks.
    d) Children's Social Behavior Questionnaire (CSBQ) Total Score at 28 weeks.
    e) General Health Questionnaire (GHQ) Total Score at 28 weeks
    f) Nijmeegse Ouderlijke Stress Index (NOSI) Total Score at 28 weeks
    g) Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Error Rates at 28 weeks
    h) Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Reaction Times for Hits and Correct Rejections at 28 weeks
    i) Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Standard Deviation of Reaction Times for Hits and Correct Rejections at 8 weeks
    j) Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Error Rates at 8 weeks
    k) Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Reaction Times for Hits and Correct Rejections at 8 weeks
    l) Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Standard Deviation (SD) of Reaction Times for Hits and Correct Rejections at 8 weeks
    m) Amsterdam Neuropsychological Tasks (ANT): Pursuit Motor Control Task - Accuracy at 8 weeks
    n) Amsterdam Neuropsychological Tasks (ANT): Pursuit Motor Control Task - Stability of Movement at 8 weeks
    o) Amsterdam Neuropsychological Tasks (ANT): Go/No-Go Response Inhibition Task - Error Rates at 8 weeks.
    p) Amsterdam Neuropsychological Tasks (ANT): Flanker Interference Task - Error Rates at 8 weeks
    q) Amsterdam Neuropsychological Tasks (ANT): Flanker Interference Task - Reaction Times at 8 weeks
    r) Cytochrome P450 2D6 Genotype (Baseline)
    E.5.2.1Timepoint(s) of evaluation of this end point
    a-j) Baseline, 16 weeks
    k-t) Baseline, 32 weeks
    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 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 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) 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? Yes
    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
    Netherlands
    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 (Last Visit of the Last Subject)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 97
    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: 80
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 17
    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 No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Paediatric population
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 97
    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)
    All eligible patients who complete the double-blind study period will have the option of participating in a 20-week open-label extension period in which patients will be treated with atomoxetine.
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Netherlands
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