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    Summary
    EudraCT Number:2019-000419-98
    Sponsor's Protocol Code Number:B4Z-US-LYEI
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2021-12-13
    Trial 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 number2019-000419-98
    A.3Full title of the trial
    Neurophysiology of Attention-Deficit/Hyperactivity Disorder (ADHD) and Comorbid Dyslexia: Functional Magnetic Resonance Imaging (fMRI) Measures of Brain Activation During Attention and Reading Tasks Pre- and Post-Atomoxetine Treatment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of Atomoxetine on Brain Activation During Attention & Reading Tasks in Participants With ADHD & Comorbid Dyslexia
    A.4.1Sponsor's protocol code numberB4Z-US-LYEI
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00716274
    A.5.4Other Identifiers
    Name:Sponsor protocol code Number:B4Z-US-LYEI
    Name:Trial NumberNumber:12212
    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 States
    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, Dyslexia.
    E.1.1.1Medical condition in easily understood language
    Attention Deficit Hyperactivity Disorder, Dyslexia.
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10013932
    E.1.2Term Dyslexia
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary: functional Magnetic Resonance Imaging (fMRI): To assess the effect of atomoxetine given orally once daily (QD) for approximately 16 weeks versus (vs) placebo in children and adolescents with Dyslexia alone, ADHD+D, or ADHD alone on brain activation patterns during fMRI patients perform the tasks of pseudoword rhyming and semantic-category tasks and the Stroop attention task. The primary efficacy measures are:
     - To assess the effect of atomoxetine vs placebo on Word Attack as measured by the Woodcock Johnson III Tests of Achievement (WJ III) in children and adolescents with Dyslexia alone for
    approximately 16 weeks
    - To assess the effect of atomoxetine vs placebo on the treatment of ADHD as measured by the ADHD Rating Scale IV (ADHDRS-IV) in children and adolescents with ADHD+D or ADHD
    alone for approximately 16 weeks
    E.2.2Secondary objectives of the trial
    1.To assess the effect of atomoxetine vs placebo in patients with Dyslexia alone for approximately 16 weeks on basic reading and vocabulary.
    2.To assess the effect of atomoxetine vs placebo in patients with ADHD+D or ADHD alone for approximately 16 weeks on 1) Executive Functioning as measured by the Brown Attention Deficit Disorder Scale-Adolescents (BADD-A)
    3.The secondary objectives of the study at 16 weeks in the Dyslexia-alone group, ADHD+D and ADHD-alone groups to evaluate the effects of atomoxetine vs placebo in children and adolescents on measures of WJ III, the Comprehensive Test of Phonological Processing(CTOPP), the Gray Oral Reading Test-4(GORT-4), the Test of Word Reading Efficiency(TOWRE), the Working Memory Test Battery for Children(WMTB-C), the BADD-A, and the ADHD Rating Scale IV-Parent Version: Investigator Administered and Rated
    4.To assess safety and tolerability.
    5.Assessment of atomoxetine on brain activation patterns during fMRI from baseline to endpoint.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria:
    •Participants in the ADHD-only or ADHD+dyslexia groups must meet DSM-IV-TR criteria for ADHD
    •Participants in the dyslexia-alone group or ADHD+dyslexia groups must meet criteria for dyslexia
    •Participants must achieve a score of 80 or more on the Full Scale Intelligence Quotient
    •Child or adolescent participants must be 10 to 16 years old
    •Must be able to communicate in English
    •Must be able to swallow capsules
    •Be reliable to keep appointments for clinic visits & all related tests
    •Participants for healthy control group do not meet DSM-IV-TR criteria for ADHD and/or dyslexia
    •Participants for healthy control group must achieve a score of at least 80 but not >120 on the Full Scale Intelligence Quotient
    E.4Principal exclusion criteria
    Exclusion Criteria:
    •Participants who weigh less than 25.1 kilogram (kg) or greater than 70 kg.
    •Participants with severe allergies to more than 1 class of medications or who have had multiple adverse drug reactions
    •Participants with prior diagnosis of bipolar I or bipolar II disorder or psychosis
    •Participants with documented history of autism, Asperger's syndrome, or pervasive developmental disorder
    •Females who are pregnant or breastfeeding
    •Participants treated with atomoxetine at a therapeutic dose (1.2 mg/kg/day) for at least 4 to 6 weeks
    E.5 End points
    E.5.1Primary end point(s)
    Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category)
    Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Attention Tasks)
    Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
    Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Stroop Tasks)
    Change From Baseline to Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version (ADHDRS) Total Score in the ADHD or ADHD + Dyslexia
    Change From Baseline to Endpoint in Woodcock Johnson Tests of Achievement (WJ III) Word Attack Total Score in Participants With Dyslexia Alone
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, 16 weeks
    E.5.2Secondary end point(s)
    1.Change From Baseline to Endpoint in Basic Reading Skills Cluster WJ III
    2,17.Change From Baseline to Endpoint in BADD-A Total Score
    3,4,5.Change From Baseline to Endpoint in WJ III Individual Test Scores
    6,7,8.Change From Baseline to Endpoint in Comprehensive Test of Phonological Processing (CTOPP) Composite Scores
    9,10,11.Change From Baseline to Endpoint in Gray Oral Reading Tests-4 (GORT-4)
    12,13.Change From Baseline to Endpoint Test of Word Reading Efficiency (TOWRE) Total Score
    14,15,16.Change From Baseline to Endpoint in Working Memory Test Battery for Children (WMTB-C)
    18.Change From Baseline to Endpoint in ADHDRS-IV Total Score
    19,20,21.Change From Baseline to Endpoint in WJ III Individual Scores
    22,23,24.Change From Baseline to Endpoint in CTOPP Composite Scores
    25,26,27.Change From Baseline to Endpoint in GORT-4
    28,29.Change From Baseline to Endpoint in Participants in TOWRE Total Score
    30,31,32.Change From Baseline to Endpoint in Participants in WMTB-C
    33, 34.Change From Baseline to Endpoint in BADD-A Total Score
    35,36.Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score
    37,38,39,40.Change From Baseline to Endpoint in fMRI Activation
    41,42,43.Change From Baseline to Endpoint in WJ III Individual Scores
    44,45,46.Change From Baseline to Endpoint in CTOPP Composite Scores
    47,48.Change From Baseline to Endpoint TOWRE Total Score
    49,50,51.Change From Baseline to Endpoint in GORT-4
    52,53,54.Change From Baseline to Endpoint in WMTB-C
    55.Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone
    56.Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia
    57.Change From Baseline to Endpoint in ADHDRS-IV Total Score in Participants With Dyslexia Alone
    58.Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With ADHD or ADHD + Dyslexia
    59.The Number of Participants With Treatment Emergent Adverse Events (TEAE) in Participants With Dyslexia
    60.The Number of Participants With TEAE in Participants With ADHD or ADHD+Dyslexia
    61.The Number of Participants With TEAE in Participants With Dyslexia
    62.The Number of Participants With TEAE in Participants With ADHD or ADHD+Dyslexia.
    63.Number of Participants With Adverse Events
    64.Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants
    65.Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants
    66.Change From Baseline to Endpoint in GORT-4 in Healthy Participants
    67.Change From Baseline to Endpoint TOWRE Total Score in Healthy Participants
    68.Change From Baseline to Endpoint in WMTB-C in Healthy Participants
    69.Change From Baseline to Endpoint in BADD-A Total Score in Healthy Participants
    70.Change From Baseline to Endpoint in ADHDRS-IV Total Score in Healthy Participants
    71.Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants
    72.Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants
    73.Change From Baseline to Endpoint in GORT-4 in Healthy Participants
    74.Change From Baseline to Endpoint in TOWRE Total Score in Healthy Participants
    75.Change From Baseline to Endpoint in WMTB-C in Healthy Participants
    76.Change From Baseline to Endpoint in BADD-A Total Score in Healthy Participants
    77.Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Healthy Participants


























    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, 16 weeks
    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
    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 (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 years0
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days8
    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: 110
    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: 64
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 46
    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
    Paediatric population
    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 110
    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)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Eli Lilly and Company
    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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