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    Summary
    EudraCT Number:2009-010276-16
    Sponsor's Protocol Code Number:F1D-MC-HGMX
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-06-22
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-010276-16
    A.3Full title of the trial
    A Long-Term, Open-Label, Safety Study of Oral Olanzapine in Adolescents with Bipolar I Disorder (Manic or Mixed Episodes) or Schizophrenia
    A.3.2Name or abbreviated title of the trial where available
    HGMX
    A.4.1Sponsor's protocol code numberF1D-MC-HGMX
    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
    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 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 Zyprexa 2,5 mg
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNOLANZAPINE
    D.3.9.1CAS number 132539061
    D.3.9.2Current sponsor codeF1D-MC-HGMX
    D.3.9.3Other descriptive nameHGMX
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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
    Bipolar I Disorder (Manic or Mixed Episodes) or Schizophrenia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level HLGT
    E.1.2Classification code 10039628
    E.1.2Term Schizophrenia and other psychotic disorders
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10057667
    E.1.2Term Bipolar disorder
    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, in adolescent patients with bipolar I disorder (mania or mixed episode) or in adolescents with schizophrenia:

    • overall safety of olanzapine for up to approximately 52 weeks of treatment (as
    described in Section 10.1), and

    • whether an intense behavioral weight intervention program is superior to a standard behavioral weight intervention program in mitigation of weight gain.
    The behavioral interventions will be assessed based on mean change from baseline body mass index (BMI) for patients with duration of treatment of at least 6 months.
    E.2.2Secondary objectives of the trial
    • to assess the mean change from baseline in BMI for all patients.

    • to assess the time to event for 7%, 15%, and 25% weight gain between patients randomized to an intense behavioural weight intervention or standard behavioral weight intervention program.

    • to assess the mean change from baseline in waist circumference for all patients.

    • to assess the efficacy of oral olanzapine treatment in adolescents, as measured using psychiatric assessments including rating scales that will assess symptoms of bipolar I disorder (Adolescent Structured Young Mania Rating Scale [YMRS]) or schizophrenia (Anchored Version of the Brief Psychiatric Rating Scale for Children [BPRS-C]) and clinical global evaluations (Clinical Global Impression of Improvement/Severity [CGI-I/CGI-S]).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    FID-MC-HGMX(1): Protocol Sample Banking Addendum: 03 March 2009
    Objectives:
    Eli Lilly and Company has established a program, Combined Specimen Banking (CSB),
    to bank samples (collectively called Banked Samples) from subjects enrolled in studies sponsored by Eli Lilly and Company. The Banked Samples are collected and banked for research to identify the genes and/or gene products and/or biochemical markers associated with diseases and/or response to clinical trial medication or other medication taken during the trial. For example, in Study FID-MC-HGMX, genes and/or gene products related to LYI 70053 and/or schizophrenia or bipolar disorder will beinvestigated.
    The research performed on the Banked Samples is limited to the clinical information
    collected on the case report form (CRF) and provided by laboratory analysis.
    Information regarding these genetic and proteomic factor(s) may benefit subjects in the future through the development of new and more specific therapeutics developed as a result of genetic/proteomic analyses.
    E.3Principal inclusion criteria
    Patients are eligible for inclusion in this study only if they meet all of the following
    criteria:

    [1] Have a diagnosis of bipolar I disorder and display an acute manic or mixed episode (with or without psychotic features) according to the DSM-IV-TR and confirmed by the K-SADS-PL, including the following diagnoses: 296.4x Bipolar I Disorder, Most Recent Episode Manic and 296.6x Bipolar I Disorder, Most Recent Episode Mixed.

    OR:

    Have a diagnosis of schizophrenia (295.10, 295.20, 295.30, 295.60, and 295.90) according to the DSM-IV-TR and confirmed by the K-SADS-PL Patients must meet diagnostic criteria at Visits 1 and 2.

    [2] Meet severity criteria as follows:
    Patients with a diagnosis of schizophrenia must obtain a BPRS-C total score >30, with a minimum score of 3 on at least one of the following items at both Visits 1 and 2:
    • hallucinations
    • delusions
    • peculiar fantasies.

    Patients with a diagnosis of bipolar I disorder must have a YMRS total score ≥15 at both Visits 1 and 2.

    [3] All females must test negative for pregnancy and must agree to abstain and/or be using a medically accepted means of contraception during the study.

    [4] Has given assent (when applicable); and has a parent or authorized legal representative who has given informed consent, is reliable, has a level of understanding sufficient to permit patient to perform all tests and examinations required by the protocol, and understands the nature of the study.

    [5] Are male or female patients, 13 to 17 years of age, who will not reach their 18th birthday before Visit 1, when informed consent is obtained.

    [6] Are capable of swallowing study medication whole (without crushing, dissolving, etc.).
    E.4Principal exclusion criteria
    Patients will be excluded from the study if they meet any of the following criteria:

    [7] Have a history of mental retardation, current comorbid autism, or current comorbid Pervasive Developmental Disorder.

    [8] Have DSM-IV-TR substance (except nicotine and caffeine) dependence within the past 30 days prior to Visit 2.

    [9] Have been judged clinically to be at any suicidal risk.

    [10] Have undergone treatment with remoxipride within 6 months (180 days) prior to Visit 2.

    [11] Have a history of allergic reaction or hypersensitivity to olanzapine.

    [12] Are receiving current pharmaceutical treatment for weight management or are participating in a structured behavioral diet and/or exercise weight loss program.

    [13] Other antipsychotics, mood stabilizers, or anticonvulsants used for the primary study conditions are excluded. Patients on these medications must have them discontinued 2 days prior to Visit 2.

    [14] Have acute, serious, or unstable medical conditions, including (but not
    limited to):
    • inadequately controlled diabetes (hemoglobin A1c [HgbA1c] >8%)
    • severe hypertriglyceridemia (fasting triglycerides ≥500 mg/dL [≥5.65 mmol/L])
    inadequately controlled thyroid disease (Patients needing a thyroid hormone supplement to treat hypothyroidism must have been on a stable dose of the medication for at least 2 months (60 days) prior to Visit 2.)
    • known uncorrected narrow-angle glaucoma
    • hepatic insufficiency (specifically any degree of jaundice)
    • cerebrovascular accidents
    • serious acute systemic infection or immunologic disease (including Human Immunodeficiency Virus positive status)
    • unstable cardiovascular disorders (including ischemic heart disease)
    • any other major renal, gastroenterologic, respiratory, endocrinologic, neurologic, or hematologic diseases (including current absolute neutrophil count <1,500 mm3 [1.5 GI/L, or 1.5 10E3/uL])

    [15] Have any illness such that death is anticipated within 1 year or intensive care unit hospitalization for the illness is anticipated within 12 months (365 days).

    [16] Have had one or more seizures without a clear and resolved etiology. However, if the patient has had one or more seizures in the past with an identifiable etiology and that etiology has been resolved, the patient may be entered. Note: the site must contact the sponsor or its representatives prior to entering a patient who has experienced any seizure.

    [17] Baseline alanine aminotransferase (ALT) values ≥2 times the upper limit of normal (ULN) of the performing laboratory or aspartate aminotransferase (AST) values ≥2 times the ULN or total bilirubin values ≥1.5 times the ULN at Visit 1.

    [18] Have leukopenia or history of leukopenia without a clear and resolved etiology or known history of agranulocytosis (absolute neutrophil count <500 mm3, <0.5 GI/L, or <0.5 10E3/μL) during the patient’s lifetime.

    [19] Prolactin level of >200 ng/mL (>200 ug/L, or >4228 mIU/L) at Visit 1.

    [20] Have QTc (Bazett’s) >450 milliseconds (males) or >460 milliseconds
    (females) at Visit 1.

    [21] Have previously been randomized in this study and/or participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to study entry (Visit 1).

    [22] Patient is currently prescribed olanzapine and has been taking olanzapine ≥5 days within 1 month (30 days) prior to Visit 1.

    [23] Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.

    [24] Are employed by or representatives of Lilly.

    [25] If female, are either pregnant or nursing.

    [26] 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.

    [27] Treatment with clozapine within 14 days prior to Visit 2.

    [28] Patients who have used olanzapine and have had treatment withdrawn due to clinically significant and/or intolerable adverse effects, or who have exhibited a lack of efficacy/response to treatment to olanzapine including treatment resistance. Prior olanzapine treatment need not be excluded if, in the opinion of the investigator, the patient’s previous treatment was inadequate in dose or duration to provide an accurate assessment of the therapy, or the effect of olanzapine was confounded by concomitant medication.
    E.5 End points
    E.5.1Primary end point(s)
    Safety evaluations are primary measures in this long-term safety study of olanzapine
    treatment in adolescent patients.
    There is no primary efficacy measure in this study as safety is the primary objective.
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    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 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 2009-06-22. 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.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state46
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 93
    F.4.2.2In the whole clinical trial 285
    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 Decision2009-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-05-07
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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