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    Summary
    EudraCT Number:2013-004903-37
    Sponsor's Protocol Code Number:D1050326
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-04-16
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2013-004903-37
    A.3Full title of the trial
    A RANDOMIZED, 6-WEEK, DOUBLE-BLIND, PLACEBO-CONTROLLED, FLEXIBLE DOSE, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF LURASIDONE IN CHILDREN AND ADOLESCENT SUBJECTS WITH BIPOLAR I DEPRESSION
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The purpose of this research study is to evaluate the safety and effectiveness of lurasidone (20 mg/day to 80 mg/day) compared to a placebo for use in children and adolescent subjects with bipolar I depression.
    A.4.1Sponsor's protocol code numberD1050326
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00844857
    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 Goldman
    B.5.3 Address:
    B.5.3.1Street AddressOne Bridge Plaza Suite 510
    B.5.3.2Town/ cityFort Lee,
    B.5.3.3Post codeNJ 07024
    B.5.3.4CountryUnited States
    B.5.4Telephone number(1) 201-592-2050
    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.3.1Product nameLURASIDONE
    D.3.2Product code SM-13496
    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 Hydrochloride
    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 typerange
    D.3.10.3Concentration number20 to 40
    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
    Bipolar I depression
    E.1.1.1Medical condition in easily understood language
    Bipolar I depression
    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 16.1
    E.1.2Level LLT
    E.1.2Classification code 10004936
    E.1.2Term Bipolar depression
    E.1.2System Organ Class 100000004873
    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 (20 - 80 mg/day flexibly dosed) compared with placebo in children and adolescent subjects with bipolar I disorder, most recent episode depressed, with or without rapid cycling disease course, and without psychotic features (diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 5th Ed. [DSM-V] criteria) as measured by the change from Baseline in the Children's Depression Rating Scale, Revised (CDRS-R) total score.
    E.2.2Secondary objectives of the trial
    Global severity as assessed by the Clinical Global Impression-Bipolar Version, Severity of Illness (CGI-BP-S) score (depression).
    Other secondary objectives of this study include evaluation of the following:
     Change in anxiety symptoms;
     Change in quality of life;
     Change in social and psychiatric functioning
     Treatment response;
     Symptom remission;
     Change in attention-deficit/hyperactivity symptoms;
     Safety and tolerability of lurasidone 20 - 80 mg/day flexibly dosed;
     Treatment-emergent mania.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female subjects 10 to 17 years of age, inclusive with bipolar I disorder, most recent episode depressed with or without rapid cycling disease course (≥ 4 episodes of mood disturbance but < 8 episodes in the previous 12 months) and without psychotic features (diagnosed by DSM-V criteria, and confirmation of the bipolar I disorder diagnosis by an adequately trained clinician at the time of screening, by means of the Schedule for Affective Disorders and Schizophrenia for School-age Children [K-SADS-PL]). Children's Depression Rating Scale, Revised (CDRS-R) total score ≥ 45 at screening and Baseline. Young Mania Rating Scale (YMRS) score ≤ 15 (with YMRS Item 1 [elevated mood] score ≤ 2) at screening and Baseline.
    E.4Principal exclusion criteria
    Has an Axis I or Axis II diagnosis other than bipolar I disorder and/or concomitant ADHD that has been the primary focus of treatment within 3 months of screening. Has a history or current diagnosis of intellectual disability, Autism Spectrum Disorder, neuroleptic malignant syndrome, or any neurologic disorder, severe head trauma, or any unstable medical condition. CDRS-R total score > 85 at screening or Baseline.
    E.5 End points
    E.5.1Primary end point(s)
    Change in the Children Depression Rating Scale, Revised (CDRS-R) total score as compared to placebo from Double-Blind Baseline to Week 6 (Day 43).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline through week 6
    E.5.2Secondary end point(s)
    Change in Clinical Global Impression-Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) as compared to placebo from Double-Blind Baseline to Week 6 (Day 43).
    Other Secondary Efficacy Endpoints:
     Change from Baseline in Pediatric Anxiety Rating Scale (PARS) score as compared to placebo.
     Change from Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) score as compared to placebo.
     Change from Baseline in Clinician-rated Children’s Global Assessment Scale (CGAS) score as compared to placebo.
     Proportion of responders, where response is defined as ≥ 50% reduction from Baseline in adjusted CDRS-R total score at last observation carried forward (LOCF) Endpoint as compared to placebo.
     Proportion of subjects achieving remission, where remission is defined as post-baseline CDRS-R Total Score ≤ 28 and Young Mania Rating Scale (YMRS) total score ≤ 8 and Clinical Global Impressions-Bipolar Version Severity (CGI-BP-S) depression score ≤ 3.
     Change from Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) score as compared to placebo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline through week 6
    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 Yes
    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 EEA20
    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
    Bulgaria
    China
    Italy
    Romania
    Colombia
    Korea, Republic of
    Malaysia
    Puerto Rico
    Spain
    Mexico
    Philippines
    Serbia
    Ukraine
    United States
    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
    LVLS (last visit last subject)
    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 months2
    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 months2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 340
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 68
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 272
    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 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 state43
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 69
    F.4.2.2In the whole clinical trial 340
    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)
    11.4.9. Follow-Up: Visit 9 Week 7 (Day 50 ± 2 days: Out-patient)
    Subjects who do not continue into the extension study (D1050302) will return to the study site for safety assessments approximately 1 week (7 ± 2 days) after taking their last dose of study drug.

    Last paragraph of the section 12.2 (of the protocol): 'Follow-up Procedures Upon Discontinuation or Withdrawal' (pages 53-54)
    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 Decision2014-07-10
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-10-12
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