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    Summary
    EudraCT Number:2012-004982-41
    Sponsor's Protocol Code Number:14865A
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-11-21
    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 number2012-004982-41
    A.3Full title of the trial
    Interventional, randomised, double-blind, parallel-group,
    placebo-controlled, flexible-dose study of brexpiprazole as
    adjunctive treatment to paroxetine or sertraline in adult
    patients suffering from post-traumatic stress disorder
    (PTSD)
    Studio interventistico, randomizzato, in doppio cieco, a gruppi paralleli, controllato con placebo, a dosi variabili, di brexpiprazolo come trattamento aggiuntivo a paroxetina o sertralina in pazienti adulti affetti da disturbo post-traumatico da stress (DPTS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Brexpiprazole as an additional treatment to paroxetine or sertraline in adult patients suffering from post-traumatic stress disorder (PTSD)
    Brexpiprazolo come trattamento aggiuntivo alla paroxetina o sertralina in pazienti adulti affetti da disturbo da stress post-traumatico (PTSD)
    A.4.1Sponsor's protocol code number14865A
    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 SponsorH. Lundbeck A/S
    B.1.3.4CountryDenmark
    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 supportH. Lundbeck A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationH. Lundbeck A/S
    B.5.2Functional name of contact pointLundbeckClinicalTrials@lundbeck.com
    B.5.3 Address:
    B.5.3.1Street AddressOttiliavej 9
    B.5.3.2Town/ cityValby, Copenhagen
    B.5.3.3Post code2500
    B.5.3.4CountryDenmark
    B.5.6E-mailLundbeckClinicalTrials@lundbeck.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 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 nameBrexpiprazole
    D.3.2Product code Lu AF41156, OPC-34712
    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.3.8INN - Proposed INNBREXPIPRAZOLE
    D.3.9.1CAS number 913611-97-9
    D.3.9.2Current sponsor codeLu-AF41156
    D.3.9.3Other descriptive nameBREXPIPRAZOLE
    D.3.9.4EV Substance CodeSUB91646
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.IMP: 2
    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 nameBrexpiprazole
    D.3.2Product code Lu AF41156, OPC-34712
    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.3.8INN - Proposed INNBREXPIPRAZOLE
    D.3.9.1CAS number 913611-97-9
    D.3.9.2Current sponsor codeLu-AF41156
    D.3.9.3Other descriptive nameBREXPIPRAZOLE
    D.3.9.4EV Substance CodeSUB91646
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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.IMP: 3
    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 nameBrexpiprazole
    D.3.2Product code Lu AF41156, OPC-34712
    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.3.8INN - Proposed INNBREXPIPRAZOLE
    D.3.9.1CAS number 913611-97-9
    D.3.9.2Current sponsor codeLu-AF41156
    D.3.9.3Other descriptive nameBREXPIPRAZOLE
    D.3.9.4EV Substance CodeSUB91646
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 placeboTablet
    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
    Post-traumatic stress disorder (PTSD)
    Disordine Post-Traumatico da stress (DPTS)
    E.1.1.1Medical condition in easily understood language
    Post-traumatic stress disorder (PTSD)
    Disordine Post-Traumatico da stress (DPTS)
    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 PT
    E.1.2Classification code 10036316
    E.1.2Term Post-traumatic stress disorder
    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 brexpiprazole up to 3 mg/day as adjunctive treatment to paroxetine or sertraline on PTSD symptoms
    valutare l'efficacia di 1-3 mg/die di brexpiprazolo sui sintomi di DPTS, quale trattamento aggiuntivo a paroxetina o sertralina
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of brexpiprazole up to 3 mg/day on global clinical impression
    - To evaluate the efficacy of brexpiprazole up to 3 mg/day on sleep quality
    - To evaluate the efficacy of brexpiprazole up to 3 mg/day on depressive and anxiety symptoms
    - To evaluate the efficacy of brexpiprazole up to 3 mg/day on functioning
    - To evaluate the efficacy of brexpiprazole up to 3 mg/day on health-related quality of life
    - To evaluate the safety and tolerability of up to 3 mg/day brexpiprazole
    valutare l'efficacia di 1-3 mg/die di brexpiprazolo su:

    • impressione clinica globale;
    • qualità del sonno;
    • sintomi depressivi e di ansia;
    • funzioni;
    • qualità della vita correlata alla salute.

    •valutare la sicurezza e la tollerabilità di 1-3 mg/die di brexpiprazolo

    E.2.3Trial contains a sub-study No
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    ANALISI ESPLORATIVA DI FARMACOGENETICA


    L’obiettivo è quello di raccogliere e conservare campioni genetici (DNA) per un eventuale studio futuro atto a scoprire se sia possibile utilizzare un gene (o una combinazione di geni) al fine di prevedere la risposta a brexpiprazolo. Inoltre, potrebbe essere condotto uno studio per tentare di individuare i geni che sono correlati a questa indicazione.
    E.3Principal inclusion criteria
    • The patient has PTSD, diagnosed according to DSM-IV-TR™ and confirmed by the Mini International Neuropsychiatric Interview (MINI).
    • The patient has a pre-defined Clinician-Administered PTSD Scale Part 2 (CAPS-2) total score at Screening and Baseline Visits.
    • The reported duration of the PTSD is at least 3 months.
    • Il paziente è affetto da DPTS, diagnosticata secondo i criteri del DSM-IV-TR™ e confermata dalla Mini International NeuropsychiatricInterview (MINI).
    • Alle visite di screening e basale il paziente presenta un punteggio totale ≥70 sulla parte 2 della scala PTSD (Disturbo post-traumatico da stress) somministrata dal medico (Clinician-Administered PTSD Scale Part 2 (CAPS-2)).
    • La durata riportata del DPTS è di almeno 3 mesi.
    E.4Principal exclusion criteria
    • The index traumatic event that led to development of PTSD took place more than 15 years before screening.
    • The patient has a severe personality disorder that in the investigator's opinion may
    interfere with the conduct of the study.
    • The patient is at significant suicidal risk.
    • L'indice di evento traumatico che ha provocato lo sviluppo del DPTS si è verificato più di 15 anni prima dello screening.
    • Il paziente ha un grave disturbo della personalità che secondo l'opinione dello sperimentatore potrebbe interferire con la conduzione dello studio.
    • Il paziente è a forte rischio di suicidio.
    E.5 End points
    E.5.1Primary end point(s)
    Change from randomisation in PTSD symptoms using CAPS-2 total score
    -variazione del punteggio totale CAPS-2 dalla randomizzazione
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and Week 28
    dal basale alla settimana 28
    E.5.2Secondary end point(s)
    - Change from randomisation in global clinical impression using CGI-S score
    - Change from randomisation in functioning using SDS score
    - Safety - number of adverse events
    - Tolerability - number of withdrawals
    -Impressione clinica globale: variazione del punteggio CGI-S dalla randomizzazione
    -Funzioni: variazione del punteggio SDS dalla randomizzazione
    -Endpoint di sicurezza: eventi avversi
    -Tollerabilità: numero di ritiri
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Change from randomisation in global clinical impression using CGI-S score -Time Frame: Baseline and Week 28
    - Change from randomisation in functioning using SDS score -Time Frame:Baseline and Week 28
    - Safety - number of adverse events-Time Frame:Up to 28 weeks and a 30-day telephone contact or clinic visit
    - Tolerability - number of withdrawals - Time Frame:Up to 28 weeks
    Up to 28 weeks and a 30-day telephone contact or
    clinic visit
    Impressione clinica globale: variazione del punteggio CGI-S dalla randomizzazione alla settimana 28.
    Funzioni: variazione del punteggio SDS dalla randomizzazione alla settimana 28.
    Sicurezza: numero di eventi avversi-Time: fino a 28 settimane ed un contatto telefonico o visita clinica ogni trenta giorni
    Tollerabilità: numero di ritiri: fino a 28 settimane e un contatto telefonico o visita clinica ogni trenta giorni
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    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
    Mexico
    United States
    France
    Argentina
    Denmark
    Italy
    Sweden
    Estonia
    Finland
    Poland
    Serbia
    South Africa
    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
    The last protocol-specified contact with the last patient ongoing in the study. Last contact may be via Telephone.
    : L'ultimo contatto specificato nel protocollo con l'ultimo paziente in corso nello studio. L’ultimo contatto può essere telefonico.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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 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: 790
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 356
    F.4.2.2In the whole clinical trial 790
    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)
    None
    Nessuno
    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 Decision2014-01-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-10-30
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