Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2007-003819-31
    Sponsor's Protocol Code Number:D1050229
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-01-15
    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 ConcernedFrance - ANSM
    A.2EudraCT number2007-003819-31
    A.3Full title of the trial
    A Phase 3 Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Efficacy of Three Doses of Lurasidone HCl in Acutely Psychotic Patients with Schizophrenia
    A.4.1Sponsor's protocol code numberD1050229
    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 SponsorDainippon Sumitomo Pharma America, Inc
    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 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 namelurasidone HCl
    D.3.2Product code SM-13496
    D.3.4Pharmaceutical form Film-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 INNlurasidone HCl
    D.3.9.1CAS number 367514-88-3
    D.3.9.2Current sponsor codeSM-13496
    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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10039626
    E.1.2Term Schizophrenia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of lurasidone HCl (40, 80, or 120 mg) compared with placebo in the treatment of patients with acute schizophrenia (diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 4th Ed. [DSM-IV] criteria) as measured by the mean change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 6.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of lurasidone HCl (40, 80, or 120 mg) compared with placebo in improving functional outcome as measured by the mean change from baseline in the Clinical Global Impression – Severity (CGI-S) at Week 6.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient agrees to participate by providing written informed consent.
    2. Patient is between 18 and 75 years of age inclusive on the day of signing informed consent.
    3. Patient meets DSM-IV™ criteria for a primary diagnosis of schizophrenia (including disorganized (295.10), paranoid (295.30), and undifferentiated (295.90) subtypes as established by clinical interview (using the Mini-International Neuropsychiatric Interview [MINI] Plus diagnostic interview). The duration of the patient’s illness, whether treated or untreated, must be greater than 1 year.
    4. Patient has an acute exacerbation of psychotic symptoms (no longer than 2 months) and marked deterioration of function from baseline (by history) or patient has been hospitalized for the purpose of treating an acute psychotic exacerbation for 2 consecutive weeks or less immediately before screening. Patients who have been hospitalized for more than 2 weeks for reasons unrelated to acute exacerbation can be included with concurrence from the Medical Monitor that such hospitalisation was for a reason other than acute relapse.
    5. Patient has a PANSS total score ≥80 at screening and baseline, with a score ≥4 (moderate) on 2 or more on the following PANSS items: delusions, conceptual disorganization, hallucinations, unusual thought content, and suspiciousness.
    6. Patient has a score ≥4 on the CGI-S at screening and baseline.
    7. Patient tests negative for selected drugs of abuse at screening and baseline.
    8. Patient is not pregnant (must have a negative serum pregnancy test at screening) or nursing (must not be lactating) and is not planning pregnancy within the projected duration of the study.
    9. A patient who is of reproductive potential (i.e., not surgically sterile or postmenopausal defined as at least 12 months of spontaneous amenorrhea or between 6 and 12 months spontaneous amenorrhea with follicle stimulating hormone (FSH) concentrations within postmenopausal range as determined by laboratory analysis) agrees to remain abstinent or use adequate and reliable contraception throughout the study, and in the investigator’s judgment, the patient will adhere to this requirement.
    Adequate contraception is defined as continuous use of either 2 barrier methods (e.g., condom and spermicide or diaphragm with spermicide) or hormonal contraceptives. Hormonal contraceptives may be permitted after the completion of a drug interaction study. Hormonal contraceptives include the following: a) contraceptive implant (such as Norplant®) inserted at least 3 months prior to washout; b) injectable contraception (such as Medroxyprogesterone acetate injection) given at least 14 days prior to washout; or c) oral contraception taken as directed for at least 1 month prior to washout.
    10. Patient is able and agrees to remain off prior antipsychotic medication for the duration of the study.
    11. Patient has had a stable living arrangement for at least 3 months prior to randomization and agrees to return to a similar living arrangement after discharge.
    12. Patient is in good physical health on the basis of medical history, physical examination, and laboratory screening.
    13. Patient is willing and able to comply with the protocol, including the inpatient requirements and outpatient visits, in the opinion of the study nurse/coordinator and the investigator.
    14. Patients who require concomitant medication treatment with the following agents may be included if they have been on stable doses for the specified times: 1) oral hypoglycemics must be stabilized for at least 1 month prior to randomization; 2) thyroid replacement must be stable for at least 3 months prior to randomization; 3) anti-hypertensive agents must be stable for at least 30 days prior to randomization.
    E.4Principal exclusion criteria
    1.Patient currently has a clinically significant neurological, metabolic (including type 1 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological disorder such as unstable angina, congestive heart failure (uncontrolled), central nervous system (CNS) infection, or history of human immunodeficiency virus (HIV) seropositivity that would pose a risk to the patient if they were to participate in the study or that might confound the results of the study.
    2. The patient has evidence of acute hepatitis, clinically significant chronic hepatitis, or evidence of clinically significant impaired hepatic function through clinical and laboratory evaluation.
    3. Patient’s estimated creatinine clearance is <60 mL/min,
    4. Patient has a history of stomach or intestinal surgery that could interfere with absorption, distribution, metabolism, or excretion of medications.
    5. Patient has a history of malignancy <5 years prior to signing the informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Pituitary tumors of any duration are excluded.
    6. The patient has evidence of any chronic organic disease of the CNS (other than schizophrenia) such as tumors, inflammation, active seizure disorder, vascular disorder, Parkinson’s disease, Alzheimer’s disease, or other forms of dementia, myasthenia gravis, or other degenerative processes. In addition, patients must not have a history of mental retardation or persistent neurological symptoms attributable to serious head injury. Past history of febrile seizure, drug-induced seizure, or alcohol withdrawal seizure is not exclusionary.
    7. Patient has a history of neuroleptic malignant syndrome (NMS).
    8. Patient exhibits evidence of severe tardive dyskinesia, severe chronic tardive dystonia, or any other severe chronic movement disorder. Severity is to be determined by the investigator.
    9. Patient is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
    10. Patient has current clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months. Exceptions include caffeine or nicotine abuse/dependence.
    11. Patient has a history of macular or retinal pigmentary disease.
    12. Patient has any abnormal laboratory parameter (with the exception of glucose or HbA1c) that indicates a clinically significant medical condition as determined by the investigator.
    13. Patient has a prolactin concentration of more than 200 ng/mL at screening or has a history of pituitary adenoma.
    14. Patient has a history or presence of abnormal electrocardiogram (ECG), which in the investigator’s opinion is clinically significant.
    15. Patient has a BMI greater than 40 kg/m2 or less than 18.5 kg/m2.
    16. Patient has, in the opinion of the study site staff, poor peripheral venous access.
    17. Patient has a history of hypersensitivity to more than 2 distinct chemical classes of drug (e.g., sulfas and penicillins).
    18. Patient is resistant to neuroleptic treatment, defined as failure to respond to 2 or more marketed antipsychotic agents from 2 different classes, given at an adequate dose for a sufficient period of time over the last 1 year.
    19. Patient has a history of treatment with clozapine for refractory psychosis and/or patient has been treated with clozapine within 4 months of randomization.
    20. Patient has received depot neuroleptics unless the last injection was at least 1 treatment cycle before randomization.
    21. Patient has received treatment with mood stabilizers, or antidepressants within 1 week of randomization, fluoxetine hydrochloride at any time within 1 month, or monoamine oxidase (MAO) inhibitors within 3 weeks of randomization.
    22. Patient requires treatment with any potent cytochrome P3A4 (CYP3A4) inhibitors or inducers during the study. Patient requires treatment with a drug that prolongs QTc interval.
    23. Patient has received electroconvulsive therapy treatment within the 3 months prior to randomization.
    24. The patient demonstrates a decrease (improvement) of >20% in the PANSS score between the screening and baseline visits, or the PANSS score falls below 80 at baseline.
    25. Patient has participated in a prior trial of lurasidone HCl.
    26. The patient was screened or washed out previously more than twice for this study (altogether, a patient may undergo no more than 3 screening and washout periods for this study).
    27. Patient is currently participating or has participated in a study with an investigational compound or device within 30 days prior to signing the informed consent. This includes studies using marketed compounds or devices.
    28. In the opinion of the investigator, patient is unable to cooperate with any study procedures, unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy endpoints will be assessed by the mean change from baseline in the following:
    • PANSS total score, positive, negative, and general psychopathology illness domain scores
    • CGI-S
    • MADRS ( week 3 and 6 only)

    at Day 4 and Weeks 1, 2, 3, 4, 5, and 6.

    Responder analyses will also be performed where response is based on the last observed value fo 20% or greater improvement from baseline in PANSS total score.

    Primary safety will be assessed by the proportion of patients with the following:
    • specific clinical and laboratory AEs
    • discontinuations due to AEs (e.g., nausea, sedation, EPS)
    • serious adverse events (SAEs)
    for 6 weeks of 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 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 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 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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    the trial design includes optional 22 months open label phase
    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.8.3 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.8.5The trial involves multiple Member States Yes
    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
    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 months9
    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 months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 65
    F.4.2.2In the whole clinical trial 480
    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)
    The trial design includes optional participation in 22 months open label extention phase. After completion of this phase the patient is expected to return to the normal treatment for their condition.
    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 Decision2008-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-10-31
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Thu May 02 19:18:55 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA