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    Summary
    EudraCT Number:2016-004973-42
    Sponsor's Protocol Code Number:1289.32
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-05-04
    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 ConcernedUK - MHRA
    A.2EudraCT number2016-004973-42
    A.3Full title of the trial
    A phase II randomised, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of orally administered BI 409306 during a 52-week treatment period as an early intervention in patients with attenuated psychosis syndrome.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This study tests whether BI 409306 prevents patients with a specific type of mental illness (attenuated psychosis syndrome) from becoming worse. This study looks at how well patients tolerate the medicine and how safe and effective it is over 1 year.
    A.4.1Sponsor's protocol code number1289.32
    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 SponsorBoehringer Ingelheim Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBoehringer Ingelheim Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH & Co. KG
    B.5.2Functional name of contact pointQRPE PSC CT Information Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhien
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number+18002430127
    B.5.5Fax number+18008217119
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.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 nameBI 409306
    D.3.2Product code BI 409306
    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.3.9.2Current sponsor codeBI 409306
    D.3.9.3Other descriptive nameBI 409306
    D.3.9.4EV Substance CodeSUB166499
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    attenuated psychosis syndrome
    E.1.1.1Medical condition in easily understood language
    attenuated psychosis syndrome
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10037234
    E.1.2Term Psychosis
    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
    The objective of this study is to investigate the efficacy, safety and tolerability of BI 409306 compared to placebo given for 52 weeks to patients with attenuated psychosis syndrome. The study is designed to show superiority of BI 409306 over placebo in achieving remission of APS as well as improvement in cognition and functional capacity.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Biomarker sub-study: EEG, Version 1.0 dated 31-Jan-2017
    Resting state EEG, auditory and visual ERP measurements will be explored and evaluated at the baseline Visit 2 (pre-dose) and Visit 23 (EOT) from a subset of the main study patient population.
    The objective of this sub-study is to measure and analyse the change of neurophysiological functions of the brain from baseline to the end of treatment in a subset of patients from the main study which is in patients with attenuated psychosis syndrome who are treated with BI 409306 50 mg b.i.d. or placebo over a treatment period of 52 weeks. The study will investigate the clinical utility of resting qEEG/ERP/auditory and visual ERP
    biomarkers for risk stratification and targeted intervention. The evaluation of EEG data will be exploratory in nature and will provide further insights on the methodologies themselves, neurophysiological changes in patients with attenuated psychosis syndrome, and the potential effect of the treatment on these measurements.

    Ocular Safety Substudy, Version 4.0 dated 04- Oct-2018
    A subset of patients from the main study will complete ocular safety tests to further characterise the ocular safety of BI 409306. Best Corrected Visual Acuity and colour vision wil be evaluated at the baseline Vist 2 ( pre-dose), 24 weeks and 52 weeks or EOT. Ocular safety wil be assessed in a descriptive way based on chnage from baselines for the following endpoints:
    -Best Corrected Visual Acuity test (BCVA) determined using a Snellan Chart
    -Total erorr score from the Farnsworth- Munsel 100 hue testing (F-M 100)
    E.3Principal inclusion criteria
    1. Meet diagnostic criteria for attenuated psychosis syndrome as defined in DSM-5 and determined by SIPS administered at screening, and diagnosis confirmed by Central Rating Committee after review of video-taped SIPS interview.
    2. Inclusion criterion 2 removed in global amendment 3. Numbering of subsquent criteria not changed.
    3.Age ≥16 and ≤ 30 years at the time of consent/assent.
    4. Male or female patients willing to use highly effective methods of contraception.
    - Female patients of childbearing potential1 must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. Patients must agree to use birth control throughout the trial and for at least 28 days after treatment has ended. Acceptable methods of birth control include combined estrogen-progestin oral, intravaginal or transdermal contraceptives, progestogen-only oral, injectable or implantable contraceptives, intrauterine devices (IUDs), intrauterine hormone releasing systems (IUSs), bilateral tubal occlusion, vasectomized sexual partner, and complete sexual abstinence (if acceptable by local health authorities) is allowed when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptom-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
    - Male patients who are able to father a child must be ready and able to be abstinent or use adequate contraception for the duration of study participation and for at least 28 days after treatment has ended.
    5. Signed and dated written informed consent in accordance with Good Clinical
    Practice (GCP) and local legislation prior to any study-related procedures OR
    signed and dated informed consent provided by the patient’s parent(s) (or legal
    guardian) and assent by the patient prior to any study-related procedures in
    accordance with GCP and local legislation2. If the patient has a legal
    representative, then this legal representative must give written informed consent
    as well.
    E.4Principal exclusion criteria
    1. Present or past diagnosis of schizophrenia, schizophreniform, schizoaffective disorder, bipolar disorder I, or major depressive disorder with psychotic symptoms according to DSM-5.
    2. Patients taking antipsychotic medication for less than 8 weeks, or patients taking antipsychotic medication for a longer duration but who have not been on a stable dose fro 8 weeks prior to informed consent.
    3. Patients who begin taking an antipsychotic between Visit 1 and Visit 2.
    4. Patients who have discontinued an antipsychotic medication less than two weeks prior to randomization.
    5. Patients taking Clozapine.
    6. Suicidal behavior in the past 2 years reported in the Columbia Suicide Severity Rating sacele ( C-SSRS) with a lethality of attempt of ≥1 , or with a lethality of 0 but a potential lethality of 2, or that in the judgement of the investigator would jeopardise the patient's safety while participating in the trial. The investigator/qualified rater must review all screening C-SSRS reports prior to randomisation, documenting an additional interivew asessing lethality of the behaviour history when appropriate.
    7. Any suicidal ideation of type 4 or 5 in the Columbia Suicide Severity Rating Scale (CSSRS) in the past 3 months (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent).
    8. In the judgment of the investigator, any clinically significant finding from the physical examination or laboratory value deviating from normal or any evidence of a clinically significant concomitant disease or any other clinical condition that would jeopardize a patient’s safety while participating in the clinical trial.
    9. Known diseases of the central nervous system (including but not limited to any kind of seizures or stroke).
    10. History of significant head injury (>5minute without consciousness).
    11. A serious developmental disorder that in the judgement of the investigator would inhibit the patient's ability to comply with all study procedures, or mental retardation (documented IQ <70), or acute attenuated symptoms exclusively related to intoxication from a psychotropic substance.
    12. Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix.
    13. Planned elective surgery requiring general anesthesia, or hospitalization for more than 1 day during the study period.
    14. Meets criteria for Substance Use Disorder (DSM-5) within the six months prior to informed consent/assent.
    15. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
    16. Patients taking strong or moderate CYP1A2 inhibitors who are also a CYP2C19 Poor Metabolizer (PM). Patients taking medication known to be strong or moderate inhibitors of CYP1A2 must be prospectively genotyped to ensure they are not poor metabolizers of CYP2C19. (A list of CYP1A2 and CYP2C19 inhibitors can be found in the ISF.).
    17. Patients taking strong or moderate CYP1A2 inhibitors who are also taking concomitant strong or moderate CYP2C19 inhibitors. (A list of CYP1A2 and CYP2C19 inhibitors can be found in the ISF.)
    18. Patients with a history of moderate to severe hepatic impairment (Child-Pugh B/C)
    19. Patients with a history of moderate to severe renal impairment (Stage 3-5)
    20. Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
    21. In the judgment of the investigator, inability of the patient to comply with the clinical trial procedures.
    22. Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational treatment(s).
    23. Previous participation in any BI 409306 study.
    24. Known hypersensitivity to the drug product excipients (lactose monohydrate, pregelatinsed starch, hydroxypropylcelluose, croscarmellose sodium, magnesium stearate, hypromellose, propylene glycol, titanium dioxide, talc and iron oxide yellow.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is time to remission from APS within a 52 week timeframe. Remission from APS is defined as a score of <3 on all the P1-P5 Positive Symptom items of the SOPS and maintained until the end of treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1: 52 weeks
    E.5.2Secondary end point(s)
    1) Time to first episode of pyschosis within a 52 week timeframe as adjudicated by a Central Rating Committee. First episode of psychosis defined as one or more SOPS P1 -P5 rated a 6 AND either a symptom is seriously disoranising or dangerous OR one of the symptoms above ocurred at least one hour per day at an average frequency of four days/week over tthe past month, OR a new prescription or increase in dose of an ongoing antipsychotic medication. Time of onset of first episode psychosis is defined using the rater's best estimate as determined in the SOPS interview of when the patient began taking a new prescription or increased the dose of antipsychotic medication.
    2) Change from baseline in everyday functional capacity as measured by Schizophrenia Cognition Rating Scale (SCoRS) total score after 24 and 52 weeks of treatment
    3) Change from baseline in the BAC App composite score after 52 weeks of treatment.
    4) Change from baseline in Positive and Negative Syndrome Scale (PANSS) positive items score, negative items score, and total score after 52 weeks of treatment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1( 52 weeks
    2) 52 weeks
    3) 52 weeks
    4) 52 weeks
    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 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) 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 concerned7
    E.8.5The trial involves multiple Member States No
    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
    Canada
    United Kingdom
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days14
    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: 30
    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: 30
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 270
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 300
    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 Decision2017-06-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-21
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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