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    Summary
    EudraCT Number:2008-000191-24
    Sponsor's Protocol Code Number:B4Z-UT-LYEL
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-03-06
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2008-000191-24
    A.3Full title of the trial
    An Open Label Pilot Study of Atomoxetine Hydrochloride in Adolescents with Attentioin-Deficit/Hyperactivity Disorder and Comorbid Cannabis Abuse
    A.4.1Sponsor's protocol code numberB4Z-UT-LYEL
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorEli Lilly Nederland
    B.1.3.4CountryNetherlands
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Nederland B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Hyperactivity Disorder
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10003736
    E.1.2Term Attention deficit/hyperactivity disorder
    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 of 1.2 mg/kg/day (once daily) for 12 weeks reduces symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) versus baseline in outpatients aged 13 through 17 years with a diagnosis of ADHD and comorbid cannabis abuse. ADHD symptoms are measured by ADHD Rating Scale-IV-Parent Version:investigator scored (ADHD-RS).
    E.2.2Secondary objectives of the trial
    •To assess whether atomoxetine reduces symptoms of ADHD as measured by Clinical Global Impression-ADHD-Improvement and Global Impression of Perceived Difficulties versus baseline.
    •To assess the safety and tolerability of atomoxetine in this population.
    •To assess the change from baseline of anxiety symptoms as measured by Pediatric Anxiety Rating Scale.
    •To assess the change from baseline of depressive symptoms as measured by Children’s Depression Rating Scale-Revised.
    •To assess neurocognitive performance as measured by a test battery (Stop-Signal Task, Timetest, Reinforcement Contingency Test).
    •To assess the change from baseline of self-rated symptoms of cannabis craving as measured by a Marijuana Craving Questionnaire.
    •To explore the cannabis consumption in patients using atomoxetine based on a Timeline Followback Calendar.
    •To explore addiction potential of atomoxetine based on a Visual Analog Scale.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients are eligible to be included in the study only if they meet all of the following criteria:
    (1) Patients must be male and female patients who are at least 13 years of age and not more than 17 years of age when the informed consent document is obtained.
    (2) Patients must have a diagnosis of ADHD based on the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision© (DSM-IV-TR©) criteria for ADHD. For the purpose of this study the diagnosis of ADHD will be confirmed during Visit 1 by administering the Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (K-SADS-PL).
    (3) At Visit 1 and 2 patients must score 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 (See Protocol Attachment LYEL.5). In addition, they must have a CGI-ADHD-S score 4 at both Visit 1 and Visit 2
    (4) Patients must meet DSM-IV-TR© criteria for cannabis abuse or dependence and use cannabis at minimum of 5 joints per week during the last month before enrollment. Current abstinence is allowed the week before enrollment.
    (5) Patients must be of normal intelligence as assessed by the investigator (that is, without a general impairment of intelligence and likely, in the investigator’s judgment, to achieve a score of 80 on an IQ test).
    (6) Patients and parents (legal representative) have been judged by the investigator to be reliable to keep appointments for clinic visits, all tests and examinations required by the protocol.
    (7) This Inclusion criterion applies to all females.
    Test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of birth control if they are sexually active (for example, use of oral contraceptives or Norplant®; a reliable barrier method of birth control [diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices]; partner with vasectomy; or abstinence) during the study and for 1 week following the last dose of study drug].
    (8) Patients must be able to swallow capsules (study drug).
    E.4Principal exclusion criteria
    (9) Patients who weigh less than 20 kg at Visit 1.
    (10) Patients with a history of Bipolar I or II disorder, schizophrenia, another psychotic disorder.
    (11) Patients who have a significant medical condition such as heart disease, prolonged QT interval, hypertension, liver or renal failure, pulmonary disease, or seizure disorder identified by history, physical examination, or laboratory tests. Patients who have taken (or are currently taking) anticonvulsants for seizure control.
    (12) Patients determined by the investigator to be at serious suicidal risk. This evaluation must include the items a, b, c, d and e of K-SADS-PL’s depression module, and there can not be a score of 3 in any of these items.
    (13) Patients with a history of alcohol or drug (other than cannabis) abuse within the past 3 months (excessive or compulsive use as judged by the investigator), or who are currently using alcohol in a manner which the investigator considers indicative of abuse or any drugs of abuse (other than cannabis), or any prescribed or over-the-counter medication in a manner which the investigtor considers indicative of abuse.
    (14) Patients with a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions.
    (15) Patients who, prior to this study, did not respond to or did not tolerate atomoxetine.
    (16) Patients with cardiovascular disease or other conditions that could be aggravated by an increased heart rate or increased blood pressure.
    (17) Patients who have a medical condition that would increase sympathetic nervous system activity markedly (for example, catecholamine-secreting neural tumour), or who are taking a medication on a daily basis, (for example, albuterol, inhalation aerosols, pseudoephedrine) that has sympathomimetic activity are excluded.
    (18) Patients who in the investigator’s judgment are likely to need psychotropic medications apart from the drug under study, including health-food supplements that in the investigator’s opinion have central nervous system activity (for example, St.John’s Wort, melatonin).
    (19) Patients who have used a monoamine oxidase inhibitor (MAOI) during the 2 weeks (14 days) prior to Visit 2.
    (20) Patients with Narrow Angle (angle-Closure) Glaucoma
    (21) Patients who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
    (22) Female patients with a positive Beta HCG pregnancy test or have recently given birth are not eligible to participate.
    (23) Patients who at any time during Study Period II are likely to begin a structured psychotherapy. Psychotherapy initiated at least 2 months prior to study participation is acceptable
    General psychoeducation is allowed at any time and recommended.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this study is to analyse the reduction of symptoms of ADHD versus baseline in outpatients aged 13 through 17 years with a diagnosis of ADHD and comorbid cannabis abuse when Atomoxetine is given at a dose up to 1.2 mg/kg/day (once daily) for 12 weeks. ADHD symptoms are measured by ADHD Rating Scale-IV-Parent Version:investigator score (ADHD-RS).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    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 Yes
    E.7.1.3.1Other trial type description
    Pilot study
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    Last patient visit
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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.1.2Adults (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 No
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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 Decision2008-03-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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