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    Summary
    EudraCT Number:2013-005451-32
    Sponsor's Protocol Code Number:F17464GE201
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-06-02
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2013-005451-32
    A.3Full title of the trial
    Effects of F17464 in acute exacerbation of schizophrenia.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of F17464 in acute exacerbation of schizophrenia.
    A.3.2Name or abbreviated title of the trial where available
    FAST (F17464 in Acute Schizophrenia Trial)
    A.4.1Sponsor's protocol code numberF17464GE201
    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 SponsorPierre Fabre Médicament represented by the Institut de Recherche Pierre Fabre (IRPF)
    B.1.3.4CountryFrance
    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 supportInstitut de Recherche Pierre Fabre
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recherche Pierre Fabre
    B.5.2Functional name of contact pointChristine PETILAIRE-BELLET
    B.5.3 Address:
    B.5.3.1Street AddressCentre de Recherche et Développement Pierre Fabre 3 avenue Hubert Curien
    B.5.3.2Town/ cityToulouse cedex 01
    B.5.3.3Post code31035
    B.5.3.4CountryFrance
    B.5.4Telephone number+33534 50 63 54
    B.5.5Fax number+33534 50 65 92
    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 nameF17464
    D.3.2Product code F17464
    D.3.4Pharmaceutical form Capsule, hard
    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 INNnot applicable
    D.3.9.2Current sponsor codeF17464
    D.3.9.4EV Substance CodeSUB32347
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboCapsule, hard
    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 17.0
    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 potential efficacy of 40 mg/day of oral F17464 in comparison to placebo over 6 weeks in patients with acute exacerbation of schizophrenia

    E.2.2Secondary objectives of the trial
    • To assess safety of the tested product
    • To describe pharmacokinetics of F17464 in this patient population
    • To assess the genotype-efficacy relationship
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Demographic Characteristics and Other Baseline Characteristics
    1. Male or female, 18-64 years of age inclusive;
    2. For female patient of child-bearing potential:
    • Must have been using an effective method of contraception (defined as surgical or hormonal birth control, or intra-uterine device only), assessed by the investigator, for at least 2 months before the enrolment in the study (Visit 1), and must accept to go on using it during the whole duration of the study and up to 1 month after the study end visit, in order to avoid pregnancy while being exposed to the study treatment. A pregnancy test will be carried out at enrolment visit (Visit 1), at inclusion visit (Visit 2) and at the End Of Treatment visit of concerned patient;
    • Agreement of her male partner(s) to use a condom during each sexual intercourse during the study period and to continue until 1 month after the study end visit;
    3. For male patient:
    • Agreement to use an effective contraceptive method himself and his female partner(s) during each sexual intercourse during the study period and to continue until 3 months after the study end visit.

    Diagnostic Criteria
    Schizophrenia history: Before Visit 1
    4. Patient with a current primary diagnosis of schizophrenia undergoing an acute exacerbation with prominent “active phase“ symptoms, as described by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition - Text Revision (DSM IV-TR) using the MINI 6.0 (Mini-International Neuropsychiatric Interview) for schizophrenia and psychotic disorders related to DSM IV-TR;
    5. For a minimum of 1 year and maximum 5 years, well-documented diagnosis with the first hospitalization for acute exacerbation of schizophrenia;
    6. Since the diagnosis of schizophrenia, the average number of hospitalisations should be no higher than 2 per year (the minimum duration of hospitalization should be more than 4 days);
    7. During the year before Visit 1, maximum 3 acute psychotic episodes that required hospitalization or change of antipsychotic medication or other therapeutic intervention;
    8. Adequate clinical response to well-conducted treatment courses during previous acute episodes. A well conducted treatment course is defined as an antipsychotic treatment with the usual doses for at least 4 weeks;
    Current acute episode:
    9. Structured Clinical Interview for the Positive And Negative Syndrome Scale (SCI-PANSS) with a PANSS total score ≥ 70 to < 120 (at Visit 1 and 2);
    10. Rating of at least 4 (moderate) on at least 2 of the following 4 PANSS positive symptoms: delusions, hallucinatory behaviour, conceptual disorganization, suspiciousness/persecution;
    11. Clinical Global Impression of Severity (CGI-S) score ≥ 4 (moderate or severe).
    12. Antipsychotic initiated for this acute episode and/ or ongoing chronic antipsychotic treatment, with a maximum of 2 antipsychotics needed to be changed (due to inefficacy or safety reasons) ;
    13. Hospitalization and/ or treatment for the current psychotic episode for less than 2 weeks prior to Visit 1;
    14. No significant improvement of PANSS total score between enrolment (Visit 1) and inclusion (Visit 2) corresponding to a score improvement < 20% on positive symptoms subscale;

    Examination

    15. Normal physical examination results, vital signs and clinical laboratory test results or other results judged not clinically significant by the investigator;
    16. Body mass index (BMI) ≥ 18 and ≤ 35kg/m2 inclusive.

    Ethical/legal considerations

    17. Patient able to read and understand the information leaflet and to give his/her written informed consent before the initiation of any study-specific procedures;
    18. Patient able to accept all the constraints of the study in the investigator’s opinion, in particular with regard to the duration of the hospitalization in the clinical centre and compliance to treatment after discharge;
    19. Patient able to report all intercurrent events that might occur during the study.
    E.4Principal exclusion criteria
    Related to the pathology

    1. Patients in their first acute episode of psychosis;

    2. Current schizophrenic episode with predominant negative symptoms;

    3. Patient « known to be refractory » defined as lack of significant improvement (no significant relief of symptoms, and no period of good function) despite adequate courses with at least 3 different antipsychotics medication cycles of an adequate duration (at least 4 weeks) and at adequate dosage during the previous 5 years;

    4. Schizoaffective disorder, schizophreniform disorder and other psychotic disorders;

    5. Bipolar I and II disorder;

    6. Pervasive developmental disorder, mental retardation, delirium, dementia, memory impairment and other cognitive disorders that would compromise a reliable assessment according to the investigator’s opinion;

    7. Known or suspected borderline or antisocial personality disorder or other DSM IV-TR axis II disorder of sufficient severity to interfere with participation in this study;

    8. History of tardive dyskinesia or chronic extra-pyramidal symptoms (EPS), serotonin syndrome or neuroleptic malignant syndrome;

    9. Major depressive disorder which requires a pharmacological treatment;

    10. At imminent risk of injuring him/herself or others or causing significant damage to property, as judged by the investigator;

    11. Suicidal risk based on the Columbia-Suicide Severity Rating Scale (C-SSRS):

    · Any suicidal behavior in the past year,

    · Suicidal ideation of type 4 or 5 in the past month.

    Related to treatments

    12. Structured psychotherapy (e.g. cognitive behavioural therapy) started within 6 weeks before Visit 1;

    13. Electroconvulsive therapy within 3 months before visit 1;

    14. Previous lack of response to electroconvulsive therapy;

    15. Treatment ongoing with a depot neuroleptic (even if less than 1 cycle in duration before visit 1);

    16. Patient having previous treatment course with clozapine within 4 months prior to Visit 1;

    17. Requirement of concomitant treatment with any of the prohibited medications, supplements, or herbal products listed in “Prohibited concomitant treatments for associated drug -drug interactions”, including any psychotropic drug or any drug with psychotropic activity or with a potentially psychotropic component;

    18. History of intolerance or hypersensitivity to other drugs of the same chemical class as F17464 or to rescue medications or any history of severe drug allergy or hypersensitivity;

    Related to medical conditions

    19. History or presence of any significant or uncontrolled medical finding such as cancer or neurological, cardiac, hepatic, metabolic, renal, haematological, muscular, endocrine, respiratory, gastrointestinal, dermatological, venereal disorders or diseases, or of any other significant medical condition that may impact the safety, the interpretation of the results, that might affect the absorption, distribution, biotransformation or excretion of the investigational product and/or the participation of the patient in the study according to the opinion of the investigator;

    20. History of seizure disorder, stroke, significant head injury, severe chronic movement disorder or psychiatric symptoms possibly secondary to any other organic medical condition;

    21. Known human immunodeficiency virus (HIV) or hepatitis B or C infection;

    22. Liver enzyme tests (AST, ALT) > 2x upper limit of normal or any abnormal level judged as clinically significant by the investigator;

    23. ECG out of normal ranges (45 ≤ HR ≤ 90 bpm, 120 ≤ PR ≤ 200 ms, QRS ≤ 110 ms, QTcF ≤ 450 ms for males and ≤ 470 for female patients) and judged as clinically significant by the investigator;

    24. For women, pregnancy or in post-partum period or a nursing mother.

    Related to habits

    25. Substance or alcohol abuse within the prior 6 months or dependence (other than benzodiazepines, nicotine or caffeine) assessed using the MINI 6.0 for schizophrenia and psychotic disorders related to DSM IV-TR;

    26. Positive result from the Urine Drug Screen (UDS).

    Others

    27. The patient is a family member or work associate of one member of the investigational site personnel;

    28. Is in a position likely to represent a conflict of interest;

    29. Has participated in a previous F17464 study;

    30. Has participated in another clinical trial within the last 6 months, has received treatment with known remnant effects or undergone investigation liable to interfere with the present clinical trial;

    31. Is participating in another clinical trial;

    32. Patient having forfeited his/her freedom by an administrative or legal obligation or being under guardianship;

    33. Is mentally unable to understand the nature, objectives and possible consequences of the trial; or refusing to subject himself/ herself to its constraints.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy parameter
    PANSS total score.
    E.5.1.1Timepoint(s) of evaluation of this end point
    All visits
    E.5.2Secondary end point(s)
    Secondary efficacy parameters
    CGI-S and CGI-I
    PANSS subscores.

    Tolerability and Safety
    - Adverse Events (observed and / or spontaneously reported)
    - Physical examinations, including body weight, BMI and waist circumference
    - Standard 12-lead ECG
    - Blood pressure and heart rate
    - CDSS (Calgary Depression Scale for Schizophrenia
    - EPS scales : BARS, AIMS, SAS
    - Suicidal risk scale: C-SSRS (Columbia-Suicide Severity Rating Scale)
    - Blood and urine laboratory tests
    - Fasting glucose
    - Hemoglobin A1c
    - Haematology
    - Biochemistry
    - Serum-hCG pregnancy test
    - Urinary pregnancy test

    Pharmacodynamics : Prolactin (PRL) (blinded for Sponsor and investigator)

    Pharmacokinetics : Plasma concentrations of F17464: 11 blood samples will be collected for each patient.

    Genotyping : Genotype regarding D3 receptors will be determined on blood sample.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary efficacy
    CGI-I : Visit 3,4,5,6,7,8,9
    CGI-S : Visit 1,2,6,9,10.

    Tolerability and safety
    Depending on examination.

    Pharmacodynamics
    Visit 2,4,5,6,9,10.

    Pharmacokinetics
    Visit 4,5,6,7,8,9.

    Genotyping
    Visit 2.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Russian Federation
    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
    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 months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months19
    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: 142
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 142
    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
    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 Decision2014-10-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-22
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