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    Summary
    EudraCT Number:2013-001695-38
    Sponsor's Protocol Code Number:D1050301
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Not Authorised
    Date on which this record was first entered in the EudraCT database:2013-12-19
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-001695-38
    A.3Full title of the trial
    A 6-WEEK RANDOMIZED, PARALLEL, DOUBLE-BLIND, PLACEBO-CONTROLLED, FIXED-DOSE, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF LURASIDONE IN ADOLESCENT SUBJECTS WITH SCHIZOPHRENIA
    Studio randomizzato della durata di 6 settimane, a gruppi paralleli, in doppio cieco, controllato con placebo, a dose fissa, multicentrico per valutare l’efficacia e la sicurezza di lurasidone in soggetti adolescenti affetti da schizofrenia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To evaluate the safety and effectiveness of two different doses of lurasidone (40 mg/day and 80 mg/day) compared to a placebo for use in adolescent children with schizophrenia.
    Studio per valutare la sicurezza e l’efficacia di due diverse dosi di lurasidone (40 mg/die e 80mg/die) verso placebo in adolescenti affetti da schizofrenia.
    A.4.1Sponsor's protocol code numberD1050301
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01911429
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/145/2012
    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 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
    schizofrenia
    E.1.1.1Medical condition in easily understood language
    Schizophrenia
    schizofrenia
    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 10001064
    E.1.2Term Acute schizophrenia
    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 (40 mg/day and 80 mg/day) compared with placebo in adolescent subjects with acute schizophrenia (diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision [DSM-IV-TR] criteria) as measured by the change from Baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 6.
    Valutare l’efficacia di lurasidone (40 mg/die e 80 mg/die) rispetto al placebo in soggetti adolescenti affetti da schizofrenia acuta (diagnosticata sulla base del Manuale diagnostico e statistico dei disturbi mentali 4a ed. criteri di revisione del testo [Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision, DSM-IV-TR]) misurata sulla variazione rispetto al basale relativamente al punteggio totale sulla Scala di sindrome positiva e negativa (Positive and Negative Syndrome Scale, PANSS) alla Settimana 6
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of lurasidone compared with placebo as measured by the change from Baseline in the Clinical Global Impression, Severity (CGI-S) at Week 6;
    - To evaluate the efficacy of lurasidone compared with placebo as measured by the change from Baseline in PANSS positive, negative, general psychopathology, and excitability subscale scores at Week 6;
    - To evaluate the efficacy of lurasidone compared with placebo in changes in quality of life as measured by the change from Baseline in the Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) at Week 6;
    - To evaluate the efficacy of lurasidone compared with placebo in changes in global functioning as measured by the change from Baseline in the Clinician-rated Children’s Global Assessment Scale (CGAS) at Week 6;
    - To evaluate the safety and tolerability of lurasidone at 40 mg/day and 80 mg/day.
    •Valutare l’efficacia di lurasidone rispetto al placebo in base alla variazione dal basale nella scala di gravità sull’impressione clinica globale (CGI-S) alla Settimana 6;
    •Valutare l’efficacia di lurasidone rispetto al placebo in base alla variazione dal basale dei punteggi delle sottoscale PANSS positiva, negativa, psicopatologica generale e di eccitabilità alla Settimana 6;
    •Valutare l’efficacia di lurasidone rispetto al placebo in base alle variazioni dal basale della qualità della vita misurata sulla variazione dal basale del questionario di godimento e soddisfazione di qualità della vita pediatrico (PQ-LES-Q) alla Settimana 6;
    •Valutare l’efficacia di lurasidone rispetto al placebo in base alle variazioni nel funzionamento globale misurato sulle variazioni dal basale della scala di valutazione globale dei bambini valutata dal medico (CGAS) alla Settimana 6;
    •Valutare la sicurezza e la tollerabilità di lurasidone a 40 mg/die e a 80 mg/die.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female subjects 13 to 17 years of age, inclusive, with DSM-IV-TR Axis I primary diagnosis of schizophrenia and confirmation of the schizophrenia diagnosis by means of the Schedule for Affective Disorders and Schizophrenia for School-age Children (K-SADS-PL). Positive and Negative Syndrome Scale (PANSS) total score ≥ 70 at screening and Baseline; CGI-S ≥ 4 at screening and Baseline.
    Soggetti di sesso maschile o femminile dai 13 ai 17 anni di età compresi, con diagnosi primaria di asse I di schizofrenia secondo il DSM-IV-TR e conferma della diagnosi di schizofrenia per mezzo della Scheda Kiddie per i disturbi affettivi e la schizofrenia passati e attuali per bambini in età scolare (Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime version, K-SADS-PL). Punteggio totale sulla Scala di sindrome positiva e negativa (PANSS) ≥ 70 allo screening e al basale; CGI-S ≥ 4 allo screening e al basale
    E.4Principal exclusion criteria
    Has an Axis I or Axis II diagnosis other than schizophrenia that has been the primary focus of treatment within 3 months of screening.; Has a history or current diagnosis of mental retardation, neuroleptic malignant syndrome, or any neurologic disorder, severe head trauma, or any unstable medical condition. PANSS total scores ≥ 120 at screening or Baseline.
    Diagnosi di asse I o di asse II diversa dalla schizofrenia che sia stata l’obiettivo primario del trattamento nei 3 mesi dello screening; anamnesi o diagnosi attuale di ritardo mentale, sindrome maligna neurolettica o qualsiasi disturbo neurologico, grave trauma cranico o qualsiasi condizione medica instabile. Punteggi totali PANSS ≥ 120 allo screening o al basale
    E.5 End points
    E.5.1Primary end point(s)
    Change from Baseline to Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6.
    Variazioni dal basale alla Settimana 6 nel punteggio totale sulla Scala di sindrome positiva e negativa (PANSS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline through week 6
    dal basale alla settimana 6
    E.5.2Secondary end point(s)
    - Change from Baseline in Clinical Global Impression severity
    (CGI-S) scale;
    - Change from Baseline in PANSS positive, negative, general psychopathology, and excitability subscale scores;
    - Change from Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q);
    - Change from Baseline in Clinician-rated Children’s Global Assessment Scale (CGAS);
    - Proportion of responders, where response is based on ≥ 20% improvement from Baseline in PANSS total score at Week 6.
    - Proportion of remitters, defined as subjects who have score not exceeding 3 (mild severity) for items P1, P2, P3, N1, N4, N6, G5, and G9 of the PANSS at Week 6.
    • Variazione rispetto al basale sulla Scala di gravità sull’impressione clinica globale (CGI-S);
    • Variazione rispetto al basale nei punteggi di sottoscala PANSS positiva, negativa, psicopatologica generale e di eccitabilità;
    • Variazione rispetto al basale del Questionario relativo alla soddisfazione e all’apprezzamento della qualità della vita (PQ-LES-Q);
    • Variazione rispetto al basale della scala di valutazione globale dei bambini valutata dal medico (Clinician-rated Children’s Global Assessment Scale, CGAS);
    • Percentuale di soggetti rispondenti, in cui la risposta sia basata sul ≥ 20% di miglioramento rispetto al basale nel punteggio totale PANSS alla settimana 6;
    • Percentuale di remittenti, definita come soggetti con punteggio pari o inferiore a 3 (gravità lieve) per le voci P1, P2, P3, N1, N4, N6, G5 e G9 di PANSS alla Settimana 6.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline through week 6
    dal basale alla settimana 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 trial3
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    End of Study (EOS): Visit 9 Week 6
    conclusione dello studio [end of study (EOS)]: visita 9 settimana 6
    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 days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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 Yes
    F.1.1Number of subjects for this age range: 249
    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.1.1.6.1Number of subjects for this age range: 249
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 249
    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)
    Please ref to:
    Section 11.4.10 of the (protocol): 'Follow-Up: Visit 10 Week 7' (page 48)
    Last paragraph of the section 12.2 (of the protocol): 'Follow-up Procedures Upon Discontinuation or Withdrawal' (pages 49-50)
    Si faccia riferimento alla sezione 11.4.10 del protocollo 'Follow-Up: Visit 10 Week 7' (pag 48) e ultimo paragrafo della sezione 12.2 'Follow-up Procedures Upon Discontinuation or Withdrawal' (pag 49-50)
    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 Decision2014-02-14
    N.Ethics Committee Opinion of the trial applicationNot-Favourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    Evaluation of the anticipated benefits and risks
    Control Group
    N.Date of Ethics Committee Opinion2014-02-12
    P. End of Trial
    P.End of Trial StatusNot Authorised
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