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    Summary
    EudraCT Number:2011-002292-41
    Sponsor's Protocol Code Number:H8Y-MC-HBDF
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-09-30
    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
    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 ConcernedGreece - EOF
    A.2EudraCT number2011-002292-41
    A.3Full title of the trial
    A Phase 3, Short-Term, Multicenter, Placebo-Controlled, Randomized Withdrawal Study of LY2140023 Monohydrate in Patients with DSM-IV-TR Schizophrenia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Physical Dependence Study in Schizophrenia
    A.3.2Name or abbreviated title of the trial where available
    HBDF
    A.4.1Sponsor's protocol code numberH8Y-MC-HBDF
    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 Information
    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 No
    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 nameLY2140023
    D.3.2Product code LY2140023
    D.3.4Pharmaceutical form Tablet
    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.3.9.1CAS number 635318-55-7
    D.3.9.2Current sponsor codeLY2140023
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Schizophrenia
    E.1.1.1Medical condition in easily understood language
    Schizophrenia
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10039626
    E.1.2Term Schizophrenia
    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
    The primary objective of this study is to assess whether LY2140023, when administered in an acute-treatment trial with flexible doses (40 or 80 mg) BID is associated with physical dependence, as measured by the occurrence of withdrawal symptoms during a randomized withdrawal phase in patients diagnosed with schizophrenia.
    E.2.2Secondary objectives of the trial
    •To characterize the symptoms observed in randomized patients treated with LY2140023 compared with those on placebo during the withdrawal phase using Rickels checklist
    •To evaluate symptoms in randomized patients treated with LY2140023 compared with those on placebo during the withdrawal phase using the CIWA-Ar scale
    •To evaluate the safety and tolerability of randomized LY2140023 compared with placebo during the withdrawal phase
    •To assess the safety and tolerability of randomized LY2140023 during the open-label treatment phase
    •To assess the efficacy of randomized LY2140023 compared with placebo during the withdrawal phase using the CGI-S and BPRS scales
    •To assess whether LY2140023, when administered in flexible doses, is associated with physical dependence within a prospectively defined subpopulation.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Patients are male or female, 18 to 65 years of age (inclusive) at study entry, with a diagnosis of schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR; APA 2000)
    •Female patients of childbearing potential must test negative for pregnancy at Visit 1 and agree to use a single, effective, medically acceptable method of birth control.
    •Patients must require a modification of antipsychotic medication or the initiation of antipsychotic medication, as indicated by their present clinical psychiatric status and/or treatment tolerability as outpatients.
    •Patients must be considered reliable and have a level of understanding sufficient to perform all tests and examinations required by the protocol, and be willing to perform all study procedures.
    •Patients must be able to understand the nature of the study and have given their own informed consent.
    E.4Principal exclusion criteria
    •Are currently enrolled in, or discontinued within the last 60 days from, a clinical trial involving an investigational product or nonapproved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
    •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.
    •Are Lilly employees
    •Patients for whom treatment with LY2140023, as specified in this protocol, is relatively or absolutely clinically contraindicated
    •Are hospitalized for an exacerbation of symptoms of schizophrenia with a discharge date in the past 2 months of Visit 1
    •Have a CGI-S score >4 at Visit 1
    •Have any other current Axis I psychiatric diagnoses in addition to schizophrenia
    •Have previously completed or withdrawn from this study, or any other study investigating LY2140023 or any predecessor molecules with glutamatergic activity
    •Patients who have received an adequate treatment trial, in the opinion of the investigator, with clozapine at doses >200 mg daily within 12 months prior to Visit 1, or who have received any clozapine at all during the month before Visit 1
    •Patients who have a history of an inadequate clinical response, in the opinion of the investigator, to antipsychotic treatment for schizophrenia. For this study, inadequate clinical response is defined as persistent and moderately severe hallucinations, delusions, or thought disorder after completion of 2 or more antipsychotic medication trials of at least 8 weeks duration the past 12 months prior to Visit 1.
    •Patients who require concomitant treatment with any other medication with primary central nervous system (CNS) activity, other than those allowed as specified in Section 9.8 (Concomitant Therapy) of the protocol or with any other medication specifically excluded in the Concomitant Medications attachment (Attachment 3) of the protocol
    •Patients who have received treatment with any depot formulation of an antipsychotic medication within 1 dosing interval, minimum of 4 weeks, prior to Visit 1
    •Patients who are actively suicidal
    •DSM-IV-TR diagnosis of substance dependence or substance abuse (except nicotine and caffeine) within the 6 months prior to Visit 1
    •Diagnosis of substance-induced psychosis by DSM-IV-TR criteria within 7 days of Visit 1 (or at any time during the study)
    •Female patients who are pregnant, nursing, or who intend to become pregnant within 30 days of completing the study
    •Have known, uncorrected, narrow-angle glaucoma
    •Have a history of 1 or more seizures
    •Patients who have had electroconvulsive therapy (ECT) within 3 months of Visit 1 or who will have ECT at any time during the study
    •Patients with untreated hyper- or hypothyroidism.
    •Have leukopenia or a history of leukopenia without a clear and resolved etiology, or known history of agranulocytosis during the patient’s lifetime
    •Patients with known medical history of human immunodeficiency virus positive (HIV+) status
    •Patients who test positive for (1) Hepatitis C virus antibody or (2)Hepatitis B surface antigen (HBsAg) with or without positive Hepatitis B core total antibody
    •Patients with ALT/SGPT or AST/SGOT values >2 times ULN of the performing laboratory, or total bilirubin values >1.5 times the ULN of the performing laboratory at Visit 1
    •Patients with acute, serious, or unstable medical conditions, including, but not limited to, inadequately controlled diabetes; severe hypertriglyceridemia; recent cerebrovascular accidents; acute systemic infection or immunologic disease; unstable cardiovascular disorders; malnutrition; or hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, or hematologic diseases
    •Prolactin level at Visit 1 of >200 ng/mL (>200μg/L), with the exception of patients presently treated with risperidone. Patients treated with risperidone prior to study screening are excluded if their prolactin level is >300 ng/mL (>300μg/L) at Visit 1.
    •Patients with a corrected QT interval (Bazett’s; QTcB) >450 milliseconds (msec) (male) or >470 msec (female) at Visit 1 (based on the central vendor’s ECG overread)
    •Are incapable of participating in the study (for example, those whose physical condition makes them unable to participate fully) or are unwilling to engage in a meaningful way as study participants (for example, patients who are unresponsive or uncooperative with investigators or site personnel). This includes patients who, in the investigator’s opinion, demonstrate overtly aggressive behavior or who are deemed to pose a homicidal risk.
    •Patients with moderate to severe renal impairment as defined by creatinine clearance (CrCl) <60 mL/min at visit 1


    E.5 End points
    E.5.1Primary end point(s)
    Maximum of the 3-day moving average of the patient’s total score on the Discontinuation Symptom Checklist Modified Rickels
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 3 weeks after randomization.
    E.5.2Secondary end point(s)
    •Change during the open label treatment phase as measured by:
    the area under the curve (AUC) for the total score and on each item of the Discontinuation Symptom Checklist-Modified Rickels over time, the Clinical Institute Withdrawal Assessment of Alcohol (CIWA-Ar) scale, treatment-emergent adverse events (TEAEs), extrapyramidal symptoms (EPS), the Barnes Akathisia Scale (Barnes), Simpson-Angus Scale (SAS), Abnormal Involuntary Movement Scale (AIMS), laboratory tests, prolactin, vital signs, electrocardiograms (ECGs), neurological examination, the Columbia-Suicide Severity Rating Scale (C-SSRS)
    •Change from randomization up to 3 weeks as measured by:
    the area under the curve (AUC) for the total score and on each item of the Discontinuation Symptom Checklist-Modified Rickels over time, the Clinical Institute Withdrawal Assessment of Alcohol (CIWA-Ar) scale, treatment-emergent adverse events (TEAEs), extrapyramidal symptoms (EPS), the Barnes Akathisia Scale (Barnes), Simpson-Angus Scale (SAS), Abnormal Involuntary Movement Scale (AIMS), laboratory tests, prolactin, vital signs, electrocardiograms (ECGs), neurological examination, the Columbia-Suicide Severity Rating Scale (C-SSRS), the Clinical Global Impression - Severity Scale (CGI-S) and the Brief Psychiatric Rating Scale (BPRS)


    •Occurrence of withdrawal symptoms during the randomized withdrawal phase

    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 3 weeks after randomization and up to 4 weeks after entering treatment

    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 Yes
    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
    Comparative safety study
    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 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 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 concerned2
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA2
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Brazil
    Greece
    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
    Last visit of the last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days7
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days28
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 150
    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 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 150
    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 specified post-trial treatment in study HBDF. However, patients who complete study HBDF will have an opportunity to roll into future open label extension study HBBV if they choose to do so and conform to eligibility criteria.
    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 Decision2011-11-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-09-18
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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
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