Borderline Personality Disorder (BPD) MedDRA version: 21.1 Level: PT Classification code 10006034 Term: Borderline personality disorder System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: Vafidemstat
Product Code: ORY-2001
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: VAFIDEMSTAT
CAS Number: 1357247-95-0
Other descriptive name: Vafidemstat
Concentration unit: mg
Sponsors
Oryzon Genomics S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 188 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •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;Secondary Objective: •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;Primary 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 ;Timepoint(s) of evaluation of this end point: From baseline to a specific weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary 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) ;Timepoint(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 | — |
Countries
Bulgaria, Germany, Serbia, Spain, United States
Contacts
Public ContactClinical Operations
Oryzon Genomics S.A.
Outcome results
None listed