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    Summary
    EudraCT Number:2016-000060-42
    Sponsor's Protocol Code Number:D1001066
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-11-22
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2016-000060-42
    A.3Full title of the trial
    A 6-Week, Randomized, Double-Blind, Placebo-Controlled Study
    to Evaluate the Efficacy and Safety of Lurasidone (SM-13496) in
    Acutely Psychotic Subjects with Schizophrenia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 6-Week Study looking at the effectiveness and Safety of Lurasidone in Acutely Psychotic Subjects with Schizophrenia
    A.4.1Sponsor's protocol code numberD1001066
    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 SponsorSunovion Pharmaceuticals 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 supportSunovion Pharmaceuticals Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSunovion Pharmaceuticals Inc.
    B.5.2Functional name of contact pointRobert S Goldman
    B.5.3 Address:
    B.5.3.1Street AddressSunovion Pharmaceuticals Inc.
    B.5.3.2Town/ cityMarlborough
    B.5.3.3Post codeMA 01752
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1201592 2050
    B.5.6E-mailRobert.Goldman@sunovion.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 Latuda
    D.2.1.1.2Name of the Marketing Authorisation holderSunovion Pharmaceuticals Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 Film-coated 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.3.8INN - Proposed INNLurasidone
    D.3.9.1CAS number 367514-88-3
    D.3.9.2Current sponsor codeSM-13496
    D.3.9.3Other descriptive nameLURASIDONE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB34204
    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 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
    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 20.0
    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
    To evaluate the efficacy of lurasidone (SM-13496) 40 mg/day compared with placebo in acutely psychotic subjects with schizophrenia as measured by change from Baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 6.
    E.2.2Secondary objectives of the trial
    Secondary Objectives
    To evaluate the efficacy of lurasidone 40 mg/day compared with placebo as measured by:
    • Change from Baseline in PANSS total score at each visit;
    • Change from Baseline in Clinical Global Impression – Severity of Illness (CGI-S) score at each visit;
    • Change from Baseline in PANSS subscale scores at each visit;
    • Change from Baseline in PANSS five-factor model scores at each visit;
    • Proportion of subjects who achieve a response, defined as 20% or greater improvement from Baseline in PANSS total score at Week 6;
    • Change from Baseline in Calgary Depression Scale for Schizophrenia (CDSS) total scores at Weeks 3 and 6;
    • Time from Baseline to all-cause discontinuation.
    To evaluate the safety of lurasidone 40 mg/day for 6 weeks compared with placebo.

    Other objectives
    • To evaluate the quality of life of lurasidone 40 mg/day compared with placebo as measured by Euroqol-5 Dimensions-3 Levels (EQ-5D-3L) index score.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study-related activities. If the subject is considered a minor per local regulations at the time of collection of the informed consent, written consent will be obtained from a legally acceptable representative (guardian) in addition to that obtained from the subject.
    2. Subject is ≥ 18 and ≤ 74 years of age, on the day of signing the informed consent.
    3. Subject meets DSM-IV-TR criteria for a primary diagnosis of schizophrenia [including disorganized (295.10), paranoid (295.30), or undifferentiated (295.90) subtypes] as established by clinical interview using the MINI 6.0 diagnostic interview with DSM-IV-TR criteria. Note: The diagnosis of schizophrenia and appropriateness of inclusion in the study will be independently confirmed by external review.
    4. Subject has a PANSS total score ≥ 80 and a PANSS subscale score ≥ 4 (moderate) on 2 or more of the following PANSS subscale items: delusions (P1), conceptual disorganization (P2), hallucinations (P3), suspiciousness (P6), or unusual thought content (G9) at Screening and Baseline.
    5. Subject must have a score of 4 (moderately ill) or higher on the CGI-S at Screening and Baseline.
    6. Subject has an acute exacerbation of psychotic symptoms (no longer than 2 months [60 days] prior to the Screening visit) and marked deterioration of function from baseline (by history). Subject must present with exacerbation of mainly positive symptoms (e.g, exacerbation of delusion or hallucination, thought disorder).
    7. Subject must be able to be hospitalized from Visit 2 (Washout) through Visit 5 (Week 2) assessments.
    8. Female subjects must not be pregnant (must have a negative serum pregnancy test at Screening) or nursing (must not be lactating) and not planning to become pregnant within the projected duration of the study.
    9. Female subjects who are of childbearing potential and male subjects whose partners are of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study
    E.4Principal exclusion criteria
    1. Subjects with an acute exacerbation of psychotic symptoms > 2 months (60 days) are not eligible for this study.
    2. Subjects who have been continuously hospitalized for > 3 months (90 days) immediately prior to screening are not eligible for this study.
    3. Subjects who have been continuously hospitalized for ≤ 14 days for acute exacerbation of psychotic symptoms immediately prior to Screening are eligible for this study.
    4. Subject has a DSM-IV Axis I or Axis II diagnosis, other than schizophrenia, that has been the primary focus of treatment within 1 year (365 days) of Screening.
    5. Subject is considered by the Investigator to be at imminent risk of suicide or injury to self, others, or answers “yes” to “Suicidal Ideation” item 4 or item 5 on the C-SSRS assessment at the Screening visit (in the past month [30 days]) or Baseline.
    6. Subject has a prolactin concentration > 100 ng/mL at Screening or has a history of pituitary adenoma.
    7. Subject has previous or existing serious cardiovascular, renal, organic brain, hematologic, endocrine, convulsive disease, or other serious medical conditions, or is considered ineligible for the study by the Investigator for any reason.
    8. Subject has a history of treatment with clozapine for refractory psychosis or treatment resistant schizophrenia.
    9. Subject is receiving a total dose of antipsychotic medication equivalent to ≥ 12.0 mg/day of haloperidol at the Screening visit.
    10. Subject requires treatment with any medications that are potent cytochrome P450 (CYP) 3A4 inhibitors or inducers for the period of 14 days prior to Baseline through the end of the study.
    11. Subject demonstrates a decrease (improvement) of ≥ 20% in the PANSS total score between Screening and Baseline visits, or the PANSS total score falls below 80 at Baseline.
    12. Subject is considered resistant to antipsychotic treatment by the Investigator, defined as per the protocol
    13. Subject has received any depot antipsychotic drugs (sustained-release formulation) more recently than the minimum required washout prior to the Screening visit.
    14. Subject received fluoxetine within 1 month (30 days) or monoamine oxidase (MAO) inhibitors within 21 days prior to the Screening visit.
    15. Subject underwent electroconvulsive therapy within 6 months (180 days) prior to the Screening visit.
    16. Subject has a history of neuroleptic malignant syndrome, water intoxication, or paralytic ileus.
    17. Subject has any abnormal laboratory parameter at Screening that indicates a clinically significant medical condition as determined by the Investigator.
    18. Subjects with type 1 diabetes, or insulin-dependent diabetics are excluded. Subjects with type 2 diabetes subjects are eligible if the protocol-specified conditions are met.
    19. Subject demonstrates evidence of acute hepatitis, clinically significant chronic hepatitis, or evidence of clinically significant impaired hepatic function through clinical and laboratory evaluation.
    20. Subject has a history of malignancy within 5 years prior to the Screening visit, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Pituitary tumors of any duration are excluded.
    21. Subject has evidence of any chronic organic disease of the central nervous system (CNS). In addition, subjects must not have a history of persistent neurological symptoms attributable to serious head injury.
    22. Subject has any gastrointestinal disorder or condition which may affect normal absorption of study medication.
    23. Subject has long QT syndrome or receives treatment with antiarrhythmic drugs of Class 1A or of Class 3 (see Section 24, Appendix V).
    24. Subject has previous or existing infection with human immunodeficiency virus (HIV).
    25. Subject has a history of hypersensitivity (including drug-induced anaphylaxis, rash, or urticaria) to 2 or more distinct chemical classes of drugs (eg, sulfas and penicillins).
    26. Subject has a history of alcohol or substance abuse (DSM-IV-TR criteria) within 3 months (90 days) prior to screening or alcohol or substance dependence (DSM-IV-TR criteria) within 12 months (365 days) prior to screening. The only exceptions include caffeine or nicotine abuse/dependence.
    27. Subject tests positive for drugs of abuse at Screening.
    28. Subject is considered by the Investigator to be affected by potent central nervous system depressants (including barbiturates and chloral hydrate).
    29. Subject has been enrolled in any interventional clinical study, including post-marketing clinical study, within 3 months (90 days) prior to signing the informed consent, or is enrolled in any other interventional clinical studies at the time of the Screening visit.
    30. Subject randomized in any other clinical study of lurasidone, or has previously taken LATUDA®.
    31. Subject is otherwise considered ineligible for the study by the Investigator.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is change from Baseline in PANSS total score at Week 6.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 6
    E.5.2Secondary end point(s)
    The secondary efficacy variables are:
    • Change from Baseline in PANSS total score at Weeks 1, 2, 3, 4, and 5;
    • Change from Baseline in CGI-S score at each post-baseline visit;
    • Change from Baseline in PANSS subscale scores at each post-baseline visit;
    • Change from Baseline in PANSS five-factor model scores at each post-baseline visit. The PANSS five-factor model is defined as follows:
    − Negative symptoms: Blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of spontaneity and flow of conversation, and active social avoidance;
    − Excitement: Excitement, hostility, tension, and poor impulse control;
    − Cognitive disorders: Conceptual disorganization, difficulty in abstract thinking, mannerisms and posturing, disorientation, and poor attention;
    − Positive symptoms: Delusions, grandiosity, suspiciousness/persecution, and unusual thought content;
    − Anxiety/depression: Somatic concern, anxiety, guilt feelings, depression, and preoccupation.
    • Proportion of subjects who achieve a response, defined as 20% or greater improvement from Baseline in PANSS total score at Week 6 last observation carried forward (LOCF) endpoint;
    • Change from Baseline in CDSS total scores at Weeks 3 and 6;
    • Time to all-cause discontinuation from Baseline.

    Other Endpoints
    • Change from Baseline in EQ-5D-3L index score at Week 6.

    Safety Endpoints
    • Frequency of adverse events (AEs) or treatment-related AEs, extrapyramidal AEs, serious adverse events (SAEs), and AEs leading to study discontinuation;
    • Absolute values and changes from Baseline in:
    − Laboratory test values including: measures of glycemic control and lipids;
    − Vital signs;
    − Body weight, waist circumference, and body mass index (BMI);
    − Electrocardiogram (ECG) parameters including QTc interval.
    • Proportion of subjects using concomitant antiparkinsonian drugs;
    • Change from Baseline in Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) total score (excluding the overall severity) at each post-baseline visit;
    • Frequency of subjects with suicidal behavior and suicidal ideation as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Various points throughout the protocol
    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) 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    Japan
    Poland
    Romania
    Russian Federation
    Slovakia
    Ukraine
    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
    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 days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days0
    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: 452
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 117
    F.4.2.2In the whole clinical trial 472
    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)
    Normal treatment or subjects have the option to enrol into an extension study to receiving study drug
    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 Decision2018-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-11-06
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