Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-003469-20
    Sponsor's Protocol Code Number:CL07-ORY-2001
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-03-11
    Trial 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 ConcernedGermany - BfArM
    A.2EudraCT number2020-003469-20
    A.3Full title of the trial
    A double blind, randomized, placebo-controlled, adaptive 14-week Phase IIb trial to evaluate the efficacy and safety of vafidemstat in an adult borderline personality disorder (BPD) population (PORTICO)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase IIb study to evaluate the safety and efficacy of vafidemstat in an adult borderline personality disorder population
    A.3.2Name or abbreviated title of the trial where available
    PORTICO
    A.4.1Sponsor's protocol code numberCL07-ORY-2001
    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 SponsorOryzon Genomics S.A.
    B.1.3.4CountrySpain
    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 supportOryzon Genomics S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOryzon Genomics S.A.
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressSant Ferran 74
    B.5.3.2Town/ cityCornellà de Llobregat, Barcelona
    B.5.3.3Post code08940
    B.5.3.4CountrySpain
    B.5.4Telephone number34647796923
    B.5.6E-mailsgutierrez@oryzon.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 nameVafidemstat
    D.3.2Product code ORY-2001
    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 INNVAFIDEMSTAT
    D.3.9.1CAS number 1357247-95-0
    D.3.9.3Other descriptive nameVafidemstat
    D.3.9.4EV Substance CodeSUB196696
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.2
    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
    Borderline Personality Disorder (BPD)
    E.1.1.1Medical condition in easily understood language
    Borderline Personality Disorder
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10006034
    E.1.2Term Borderline personality 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 investigate the efficacy of vafidemstat in the treatment of agitation and aggression in adult BPD patients
    • To investigate the efficacy of vafidemstat in the treatment of adult BPD patients
    E.2.2Secondary objectives of the trial
    • To investigate the effect of vafidemstat in reducing the severity of BPD symptoms in adult patients
    • To evaluate the safety of vafidemstat in adult BPD patients
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women 18-65 years of age.
    2. Subject must meet DMS-5 diagnostic criteria for BPD at least 3 months before the Screening visit. The Mini-International Neuropsychiatric Interview (MINI) will be administered at screening in order to confirm BPD diagnosis, as well as to confirm subject does not meet other relevant exclusion criteria.
    3. Agitation-Aggression Psychiatric Inventory (AAPI) subscale of >/= 16 (severity x frequency) summed across the four (4) items comprising the Agitation/Aggression (A/A) subscale, and the sum of the A/A Subscale severity scores >/= 6.
    4. Stable living environment for > 6 months before the Screening visit.
    5. Body mass index (BMI) of at least 18.5 kg/m2, but no more than 35 kg/m2.
    6. Willing and able to adhere to the prohibitions, restrictions and requirements specified in this protocol.
    7. Otherwise healthy and medically stable based on medical history.
    8. Clinical and neurological examinations and laboratory tests, as well as 12-lead ECG performed during screening that confirms subject is healthy and medically stable.
    9. Able to read and write fluently and must have adequate hearing and visual acuity to complete the required testing outlined in this protocol.
    10. Stable in their permitted regimen of background therapy (see section 6.1.2) for concomitant medications at the Screening visit. Subjects should maintain treatment throughout the study and not initiate any prohibited medications during the trial, as well as should agree to inform their study physician of any medication changes throughout the trial.
    11. Enrolled subjects will need to maintain their pre-screening psychotherapy schedule throughout the trial duration. That is, subjects receiving psychotherapy will need to have it started at least 3 months before the Screening visit and remain in psychotherapy throughout the trial. Subjects not receiving psychotherapy should not initiate psychotherapy during the trial.
    12. Fertile male and female subjects must use highly efficient contraception, from the Screening visit until 30 days after last dose of the IMP, defined as:
    A method with less than 1% failure rate (e.g. permanent sterilization, hormone implants, hormone injections, some intrauterine devices, or vasectomized partner)
    OR
    The use of two methods of contraception (e.g. one barrier method [condom, diaphragm or cervical/vault caps] with spermicide and one hormonal contraceptive [e.g. combined oral contraceptives, patch, vaginal ring, injectable and implants])
    OR
    Abstinence
    13. Female subjects of childbearing potential must have a negative urine pregnancy test at screening and baseline.
    14. Signed informed consent by patient prior to the initiation of any study specific procedure.
    E.4Principal exclusion criteria
    1. Failure to perform screening or baseline procedures.
    2. DSM-5 diagnosis of Intellectual Disability, Autism Spectrum Disorder, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder (or related disorders) or Major Depressive Disorder (MDD) with psychosis.
    3. Current DSM-5 diagnosis of Conduct Disorder, Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder, Oppositional Defiant Disorder, Paranoid Personality Disorder or Obsessive-Compulsive Disorder.
    4. Current DSM-5 diagnosis of Panic Disorder or Post-Traumatic Stress Disorder (PTSD).
    5. History of moderate or severe substance or alcohol use disorder according to DSM-5, with the exception of nicotine and caffeine, within 6-months before screening.
    6. Use of illicit drugs (including medically indicated illicit drugs) for at least one week before Screening and subjects unwilling to abstain from use of these substances during the study. Use of alcohol or cannabinoids is not allowed within 24 hours prior to a study visit.Regarding cannabis,
    patient self-report of abstinence within 24 hours will be used for
    inclusion decision-making versus the urine drug test results.
    7. Hospitalization or medication change for any reason, two months prior to the Screening visit or during the Screening period, that makes the subject medically or mentally unsuitable for trial participation.
    8. Clinically significant, advanced or unstable disease that is likely to result in rapid deterioration of the subject’s condition or affect their safety during the study.
    9. Positive results for HIV, Hepatitis C or Hepatitis B at the screening visit
    10. Uncontrolled hypo- or hyperthyroidism at screening visit, based on laboratory parameters.
    11. Clinically significant infection within the previous 30-days
    12. Chronic drug intake of:* (Due to a lack of space please refer to the full protocol to see this criteria 12 within all it's parts (subsections 12.a to 12.m)
    13. Esketamine in the past 90 days before the Screening visit.
    14. Electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) in the past 90 days before the screening visit.
    15. Any regular intake of medications acting directly on central nervous system that investigator considers relevant to the study.
    16. Member or immediate family of the study personnel or subordinate to any of the study personnel.
    17. Enrollment in another investigational study or intake of investigational drug within the previous 3 months.
    18. Suicide attempt within the 6-month prior to the Screening visit or significant risk of suicide.
    19. Any condition that in the opinion of the investigator makes the subject unsuitable for inclusion in the study.
    Please refer to the protocol to find the complete text.
    E.5 End points
    E.5.1Primary end point(s)
    Primary – Efficacy
    • To evaluate the difference on the Clinical Global Impression-Severity focused on Agitation/Aggression (CGI-S A/A) from baseline to specific weeks, between the active treatment arm and the placebo arm
    • To evaluate the difference on the Borderline Personality Disorder Checklist (BPDCL), from baseline to specific weeks, between the active treatment arm and the placebo arm
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to a specific weeks
    E.5.2Secondary end point(s)
    Secondary – Efficacy
    • To evaluate the change over time on the CGI-S A/A
    • To evaluate the change over time on the BPDCL
    • To evaluate the difference on the following measures, from baseline to specific weeks, as well as change over time, between the active treatment arm and the placebo arm:
    a) Borderline Evaluation of Severity over Time (BEST)
    b) Beck Depression Inventory – II (BDI-II)
    c) State-Trait Anger Expression Inventory 2 (STAXI-2)
    d) State-Trait Anxiety Inventory (STAI)

    Secondary – Safety
    • To evaluate the following safety endpoints throughout the study, from baseline to week 14, including:
    a) Number, frequency and severity of Treatment Emergent Adverse Events (TEAEs)
    b) Number, frequency and severity of Serious TEAEs
    c) Number and percentage of withdrawn subjects due to TEAEs
    d) Frequency of physical examination parameters, vital signs and ECG parameters of potential clinical concern throughout the study period
    e) Frequency of clinical laboratory parameters (hematology, including platelets, and clinical chemistry) of potential clinical concern throughout the study period
    f) Columbia – Suicide Severity Rating Scale (C-SSRS)
    g) Use of concomitant medication throughout the study period

    • To evaluate the change from baseline to specific weeks of the following safety endpoints:
    a) Physical examination, vital signs and ECG parameters
    b) Clinical laboratory parameters (hematology, including platelets, and clinical chemistry)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy endopoint: from baseline to a specific weeks
    Safety endpoints: from baseline to week 14, from baseline to a specific week
    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) 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    Serbia
    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
    The end of study is defined as the date of the last patient last visit (LPLV), described in the protocol as last patient out (LPO)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 months11
    E.8.9.2In all countries concerned by the trial days27
    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: 188
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 114
    F.4.2.2In the whole clinical trial 188
    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)
    According to medical practice
    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 Decision2021-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-11-13
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Thu Apr 25 11:16:00 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA