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    Summary
    EudraCT Number:2011-004790-90
    Sponsor's Protocol Code Number:D1050307
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-09-26
    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 number2011-004790-90
    A.3Full title of the trial
    A 12-week, multicenter, open-label extension study in subjects with schizophrenia.
    Studio di estensione di 12 settimane, multicentrico, in aperto in soggetti affetti da schizofrenia (protocollo n. D1050307)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 12-week, multicenter, open-label extension study in subjects with schizophrenia.
    Studio di estensione di 12-settimane, multicentrico, in aperto in soggetti affetti da schizophrenia (protocollo n. D1050307).
    A.4.1Sponsor's protocol code numberD1050307
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01566162
    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 organisationPharmaNet/i3 LLC
    B.5.2Functional name of contact pointApril Buffaloe, GlobalStudyStartUp
    B.5.3 Address:
    B.5.3.1Street Address1001 Winstead Ave, Suite 200
    B.5.3.2Town/ cityCary, NC
    B.5.3.3Post code27513
    B.5.3.4CountryUnited States
    B.5.4Telephone number001 919 7908683
    B.5.5Fax number001 973 2419870
    B.5.6E-mailabuffaloe@pharmanet-i3.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
    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 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 367514-88-3
    D.3.9.2Current sponsor codeSM-13496 (Lurasidone HCl)
    D.3.9.3Other descriptive nameLurasidone Hydrochloride
    D.3.9.4EV Substance CodeSUB32185
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number40 to 80
    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
    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 is a psychotic disorder (or a group of disorders) marked by severely impaired thinking, emotions, and behaviours.
    La schizofrenia è un disturbo psichiatico (o un gruppo di disturbi)caratterizzato da un grave riduzione della capacità di riflessione, emozionale e di comportamento.
    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 15.0
    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 the study is to evaluate the longer term safety and tolerability of lurasidone flexibly dosed at 40 or 80 mg/day over 12-week period in subjects with schizophrenia who have previously been treated with lurasidone.
    L'obiettivo primario dello studio è valutare la sicurezza e la tollerabilità a più lungo termine del lurasidone ad una dose flessibile di 40 o 80 mg/die per 12 settimane in soggetti affetti da schizopfrenia che sono stati trattati precedentemente con lurasidone.
    E.2.2Secondary objectives of the trial
    The secondary objective of the study is to evaluate the longer term effictiveness of lurasidone flexibly dosed at 40 or 80 mg/day over 12-week period in subjects with schizophrenia who have previously been treated with lurasidone.
    L'obiettivo secondario dello studio è valutare l'efficacia a più lungo termine del lurasidone ad una dose flessibile di 40 o 80 mg/die per 12 settimane in soggetti affetti da schizopfrenia che sono stati trattati precedentemente con lurasidone.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects provides written informed consent and is willing and able to comply with the protocol, in the opinion of the investigator. 2. Subject has completed the 28-week double-blind phase of study D1050238 or Subject has experienced a protocol-defined relapse event during the double-blind phase in study D1050238 and has completed all required assessments on the final study visit (Study Visit Number 42) in study D1050238. or Subject is participating in the open-label or double-blind phase of study D1050238 if/when study D1050238 is terminated by the sponsor and has completed all required assessments on the final study visit (Study Visit Number 42) in study D1050238. 3. Subject is judged by the Investigator to be suitable for participation in a 12-week clinical trial involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator. 4. Subject is not pregnant at the extension baseline visit (must have a negative urine pregnancy test at the final study visit in Study D1050238)or nursing (must not be lactating) and is not planning pregnancy within the projected duration of the study. 5. Males and female subjects who are of reproductive potential agree to remain abstinent or use adequate and reliable contraception throughout the study and for at least 30 days after the last dose of lurasidone has been taken. 6. Subject is in good physical health on the basis of physical examination at the extension baseline visit (performed at the final study visit in Study D1050238).
    1. Soggetti che hanno accettato di partecipare fornendo il consenso informato scritto e sono abili a soddisfare i requesiti del protocollo. 2.Soggetti che hanno completato lo studio di 28 settimane in doppio cieco D1050238 e ai quali sono stati effettuati tutte le valutazioni finali dello studio (Visita 42) oppure hanno avuto un'esperienza di recidiva (secondo la definizione del protocollo) nel corso della fase in doppio cieco dello studio D1050238 oppure il soggetto sta partecipando alla fase in aperto o in doppio cieco dello studio D1050238 qualora lo studio D1050238 venga terminato dallo sponsor e il soggetto ha completato tutte le valutazioni richieste nel corso della visita finale dello studio (visita dello studio n. 42) nell’ambito dello studio D1050238. 3. A giudizio dello sperimentatore, il soggetto è idoneo alla partecipazione a una sperimentazione clinica di 12 settimane che implica il trattamento in aperto con lurasidone. 4. Il sggetto non è in gravidanza al momento della visita basale (deve avere un test di gravidanza delle urine negativo alla visita finale dello studio D1050238). 5. Uomini e donne in età fertile debbono accettare di astenersi ad avere rapporti sessuali o di usare un sistema contraccettivo adeguato nel corso dello studio e per 30 giorni successivi l'ultima dose di lurasidone. 6. Soggetti in buona salute fisica sulla base dell'esame obiettivo alla visita basale (effettuata alla visita finale dello studio D1050238).
    E.4Principal exclusion criteria
    1. Subject is considered by the investigator to be at imminent risk of suicide, injury to self or to others, or damage to property.
    2. Subject answers "yes" to "Suicidal Ideation" item 4 (active suicidal
    ideation with some intent to act, without specific plan) or item 5 (active
    suicidal ideation with specific plan and intent) on the Columbia Suicide
    Severity Rating Scale (C-SSRS) at the extension baseline visit (final
    study visit in Study D1050238). Subjects who answer "yes" to this
    question must be referred to the Investigator for follow-up evaluation.
    3. Subject requires treatment with any potent CYP3A4 inhibitors or
    inducers during the study. Subject requires treatment with a drug that
    consistently prolongs the QTc interval.
    4. Subject 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), or central
    nervous system (CNS) infection that would pose a risk to the subject if
    they were to participate in the study or that might confound the results
    of the study. Subjects with human immunodeficiency virus (HIV)
    seropositivity (or history of seropositivity) will be excluded.
    Note: Active
    medical conditions that are minor or well-controlled are not exclusionary
    if they do not affect risk to the subject or the study results.
    5. Subject exhibits evidence of severe tardive dyskinesia, severe
    dystonia, or any other severe movement disorder. Severity is to be determined by the Investigator.
    6. Subject has presence of abnormal electrocardiogram (ECG) at the
    extension baseline visit (final study visit in Study D1050238).
    1. A giudizio dello sperimentatore, il soggetto è considerato a imminente rischio di suicidio o di infliggere lesioni o danni a sè, ad altri o alle cose.
    2. Il soggetto risponde “sì” alla voce 4 “ideazione suicidaria” (ideazione suicidaria attiva con intenzione di agire, senza un piano specifico) o alla voce 5 (ideazione suicidaria attiva con un piano specifico e con intenzione) sul C-SSRS nel corso della visita basale dell’estensione (visita dello studio n. 42 nell’ambito dello studio D1050238). I soggetti che rispondono “sì” a questa domanda devono essere indirizzati dallo sperimentatore alla valutazione di follow-up e al trattamento opportuno.
    3. Il soggetto necessita di un trattamento con un potente inibitore CYP3A4 durante lo studio. Il soggetto necessita di un trattamento con un farmaco che prolunga in modo consistente l'intervallo QTc.
    4. Il soggetto ha una patologia importante neurologica, metabolica (incluso il diabete di tipo 1), epatica, renale, ematologica, polmonare, cardiovascolare, gastrointestinale, e/o urologica come
    l'angina instabile, insufficienza cardiaca congestizia (non controllata)e un'infezione del sistema nervoso centrale che può porre il soggetto a rischio se partecipa allo studio o che potrebbe interferire con i risultati dello studio. Soggetti con immuno deficienza umana (HIV) saranno esclusi. Note: condizioni cliniche in atto che sono minori o ben controllate non sono motivo di esclusione se esse non influenzano il rischio del soggetto o i risultati dello studio.
    5. Il soggetto manifesta una evidente e grave discinesia tardiva, grave distonia, o ogni altro disturbo del moviemnto grave.
    6. Il soggetto presenta un elettrocardiogramma (ECG) anormale alla visita basale dell'estensione (vista finale dello studio D1050238).
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability will be assessed by the proportion of subjects
    with the following:
    - Clinical and laboratory treatment-emergent adverse events (TEAEs)
    - TEAEs leading to discontinuation
    - Serious AEs (SAEs).
    Safety and tolerability will further be assessed by the following
    parameters;
    - Clinical review of TEAEs and laboratory values (including serum prolactin)
    - ECG findings
    - Physical examination
    - Weight
    - Vital signs
    - Columbia Suicide Severity Rating Scale (C-SSRS).
    Sicurezza e tollerabilità verranno valutati secondo la percentuale di pazienti con i seguenti:
    - Eventi avversi clinici e di laboratorio emergenti (TEAEs)
    - TEAEs che determinano un interruzione
    - Eventi Avversi seri (SAEs).
    Sicurezza e tollerabilità verranno valutate con i seguenti parametri:
    - Revisione dei TEAEs e dei valori di laboratorio (inclusa la prolattina serica)
    - tracciati ECG
    - Esame obiettivo
    - Peso
    - Segni vitali
    - valutazione della Scala Columbia Suicide Severity Rating (C-SSRS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 2, 4, 8, 12 e 13.
    Settimana 2, 4, 8, 12 e 13.
    E.5.2Secondary end point(s)
    Effectiveness endpoints will be assessed by the following parameters:
    - MADRS total score.
    - Positive and Negative Syndrome Scale (PANSS) score.
    - Clinical Global Impression , Severity of Illness (CGI-S) score
    -Health Services Utilization Questionnaire (HSUQ) (US sites only).
    - SF-12 Health Survey.
    - Intend to attend assessment.
    Efficacia valutata con i seguenti parametri:
    - punteggio totale della MADRS.
    - punteggio della Positive and Negative Syndrome Scale (PANSS)
    - Impressione Clinica Globale, Gravità della malattia (CGI-S).
    - Questionario sull'Utilizzo dei Servizi Sanitari (HSUQ) (solo nei centri USA).
    - Questionario sullo Stato di Salute SF-12.
    - Valutazione "Intent to Attend"
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 2, 4, 8 e 12.
    Settimana 2, 4, 8 e 12.
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Croatia
    India
    Russian Federation
    South Africa
    Ukraine
    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 Patient undergoing the trial.
    Ultima VIsita dll'Ultimo Paziente.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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.1.1Number of subjects for this age range: 0
    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: 240
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 250
    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)
    Subjects who have completed participation in Study D1050307 and who
    may benefit from the study drug and meet eligibility criteria will have
    the option to participate in an ongoing extended use study D1050298 in
    which they will receive open-label, flexibly dosed lurasidone for up to
    18 months. Subjects who discontinue the trial early will not be eligible
    for the aforementioned extended use trial and will not receive
    lurasidone following the completion trial.
    I soggetti che hanno completato la partecipazione nello Studio D1050307 e che possono avere un benificio
    dal farmaco in studio e che soddisfano i criteri di inclusione avranno l'opzione di partecipare a una fase di estensione e riceveranno il lurasidone in aperto a dosaggio flessibile sino a 18 mesi. I soggetti che interromperanno il trial precocemente non saranno eleggibili per lo studio di estensione e non riceveranno lurasidone dopo il completamento del trial.
    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 Decision2012-08-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-11-05
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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
    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.

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