Borderline Personality DisorderPhase 2NCT04932291
Study to Test the Efficacy and Safety of Vafidemstat in Adult Borderline Personality Disorder Population
A Phase 2 study testing vafidemstat in people with Borderline Personality Disorder, run by Oryzon Genomics S.A. at 21 sites in 5 countries.
Trial summary
PORTICO is a Phase IIb study to evaluate the efficacy and safety of vafidemstat in an adult borderline personality disorder (BPD) population. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- vafidemstat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 211 participants
- Where
- 21 sitesin 5 countries
- Study dates
- 26 Mar 2021to 13 Nov 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main inclusion criteria:
- Men and women 18-65 years of age.
- DSM-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.
- Agitation-Aggression Psychiatric Inventory-Clinician Report (AAPI-CR) Agitation \& Aggression (A/A) subscale score of ≥ 16 (severity x frequency) summed across the four (4) items comprising the A/A subscale, and the sum of the A/A subscale severity scores ≥ 6.
- Stable living environment for > 6 months before the Screening visit.
- Body mass index (BMI) of at least 18.5 kg/m2, but no more than 35 kg/m2.
- Willing and able to adhere to the prohibitions, restrictions and requirements specified in this protocol.
- Otherwise, healthy, and medically stable based on medical history.
- Clinical and neurological examinations and laboratory tests, as well as 12-lead ECG performed during screening that confirms subject is healthy and medically stable.
- Able to read and write fluently and must have adequate hearing and visual acuity to complete the required testing outlined in this protocol.
- Stable in their permitted regimen of background therapy as per drug labeling for concomitant medications at the Screening visit and they should maintain treatment throughout the study and not initiate any prohibited medications during the trial. Subjects should agree to inform their study physician of any medication changes throughout the trial.
- 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.
- 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])
- Female subjects of childbearing potential must have a negative urine pregnancy test at screening and baseline.
- Signed informed consent by participant prior to the initiation of any study specific procedure.
Main exclusion criteria
- Failure to perform screening or baseline procedures.
- DSM-5 diagnosis of intellectual disability, autism spectrum disorder, schizophrenia, schizoaffective disorder, bipolar disorder (or related disorders) or major depressive disorder (MDD) with psychosis.
- Current DSM-5 diagnosis of conduct disorder, anorexia nervosa, bulimia nervosa, binge-eating disorder, oppositional defiant disorder, paranoid personality disorder or obsessive-compulsive disorder.
- Current DSM-5 diagnosis of panic disorder or post-traumatic stress disorder (PTSD). However, subjects with PTSD, generalized anxiety disorder (GAD), social anxiety disorder (SAD), MDD without psychosis, attention deficit hyperactivity disorder (ADHD) are eligible if symptoms have been stable for at least 90 days prior to the Screening visit, these disorders are not the primary focus of treatment, changes in any treatment for these disorders would not likely be required for the duration of the study, and in the investigator´s opinion these disorders will not interfere with the assessment and/or accuracy of the study endpoints.
- 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.
- Use of 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.
- 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.
- 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.
- Positive results for tuberculosis, Human Immunodeficiency Virus (HIV), Hepatitis C or Hepatitis B serology obtained at the Screening Visit.
- Uncontrolled hypo- or hyperthyroidism at Screening Visit, based on laboratory parameters.
- Clinically significant infection within the previous 30-days.
- Chronic drug intake of specific forbidden medication
- Esketamine in the past 90 days before the Screening visit.
- Electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) in the past 90 days before the screening visit.
- Any regular intake of medications acting directly on central nervous system that investigator considers relevant to the study.
- Member or immediate family of the study personnel or subordinate to any of the study personnel.
- Enrollment in another investigational study or intake of investigational drug within the previous 3 months.
- Suicide attempt within the 6-month prior to the Screening visit or significant risk of suicide.
- Any condition that in the opinion of the investigator makes the subject unsuitable for inclusion in the study.
Trial locations and contacts
21 sites in 5 countries.
21 sites in 5 countries
United States11 sites
Neurobehavioral Research Inc.
Cedarhurst, New York, 11516
Center for Emotioal Fitness
Cherry Hill, New Jersey, 08002
University of Chicago Institutional Review Board
Chicago, Illinois, 60637-1426
Revive Research Institute
Elgin, Illinois, 60123
Core Clinical Research
Everett, Washington, 98201
New Life Medical Research Center
Hialeah, Florida, 33012
Phoenix Medical Research LLC
Miami, Florida, 33165
The Medical Research Network
New York, New York, 10128
Excell Research Inc
Oceanside, California, 92056
Excell Research, Inc.
Oceanside, California, 92056
Adams Clinical Trials, LLC
Watertown, Massachusetts, 02472
Bulgaria3 sites
Medical Center Intermedika
Sofia, Sofia-Grad, 1680
Medical Center Hera EOOD - Psychiatry Office
Sofia, Sofia-Grad, 9000
DCC "Mladost-M" Ltd, Psychiatr
Varna, 9000
Serbia3 sites
Clinic for psychiatric disorders "Laza Lazarevic"
Belgrade, 11000
Clinical center of Serbia
Belgrade, 11000
Clinical center Kragujevac
Kragujevac, 3400
Germany2 sites
Emovis GmbH
Berlin, 10629
Klinik fur Psychiatrie und Psychotherapie, LMU
München, Bavaria, 80336
Spain2 sites
Hospital Vall d'Hebron
Barcelona, 08035
Hospital Clínico San Carlos
Madrid, 28040
About this study
Official title: "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)"
PORTICO is a Phase IIb study to evaluate the efficacy and safety of vafidemstat in an adult borderline personality disorder (BPD) population.
Read the detailed description
PORTICO is 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.
- Conditions
- Borderline Personality Disorder
- Being tested
- vafidemstat, Placebo
- Keywords
- Borderline personality disorder, vafidemstat
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vafidemstatDrug
Also called ORY-2001
1.2mg capsule
PlaceboDrug
placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| vafidemstat 1.2mg | Experimental | Vafidemstat is administered as capsules. Receives: Drug: vafidemstat |
| placebo | Placebo comparator | Placebo is administered as capsules. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Difference in the CGI-S A/A From Baseline to Average of Weeks 8 to 12
Change on the CGI-S A/A from Baseline to average of Weeks 8 to 12, between the active treatment arm (Vafidemstat 1.2 mg) and the placebo arm (full analysis set).
- Full scale name: Clinical Global Impression-Severity focused on Agitation/Aggression
- Scale construct: the CGI-S A/A is a clinician's global rating of the BPD patients' severity of agitation and aggression symptoms at the time of evaluation.
- Scale items: 1.
- Scale range values: 0 to 7. Higher scores reflect greater severity of BPD-related agitation and agression symptoms.
- Scale score: 0 (min) - 7 (max).
Measured: From Baseline-Week 0 to average of Weeks 8 to 12
Efficacy: Difference in the BPDCL-Total Score From Baseline to Average of Weeks 8 to 12
Change on the BPDCL-Total Score from Baseline to average of Weeks 8 to 12, between the active treatment arm (Vafidemstat 1.2 mg) and the placebo arm (full analysis set).
- Full scale name: Borderline Personality Disorder Checklist.
- Scale construct: the BPDCL is a patient-reported outcome measure of BPD symptoms' severity over the past 2 weeks. The Total Score is a global score representing overall BPD symptom burden.
- Scale items: 47 items.
- Scale range values: 1 to 5 for each item.
- Scale score: Total Score=47 (min) - 235 (max) as the sum of the 47 items scores. Higher scores reflect greater severity of BPD symptoms.
Measured: From Baseline-Week 0 to average of Weeks 8 to 12
Secondary outcomes (16)
Efficacy: Difference in the BEST-Total Score From Baseline to Average of Weeks 8 to 12
Change on the BEST-Total Score from Baseline to average of Weeks 8 to 12, between the active treatment arm (Vafidemstat 1.2 mgr) and the Placebo arm (full analysis set).
- Full scale name: Borderline Evaluation of Severity Over Time.
- Scale construct: the BEST is a 15-item patient-reported outcome measure of BPD symptoms' severity and coping responses over the past 2 weeks.
- Scale items: 15 items comprising 3 subscales (subscale A-Thoughts and Feelings=8 items; subscale B-Negative Behaviors=4 items; subscale C-Positive Behaviors=3 items).
- Scale range values: 1 to 5 for each item. Subscale A \& B: 1=None/Slight, 5=Extreme. Subscale C: 1=Almost Never, 5=Almost Always.
- Scale score: 12 (min) - 72 (max) as per the formula 15 + A + B - C. Higher scores reflect greater severity of BPD symptoms.0
Measured: From Baseline-Week 0 to average of Weeks 8 to 12
Efficacy: Difference in the BDI-II Total Score From Baseline to Average of Weeks 8 to 12
Change on the BDI-II-Total Score from Baseline to average of Weeks 8 to 12, between the active treatment arm (Vafidemstat 1.2 mg) and the Placebo arm (full analysis set).
- Full scale name: Beck Depression Inventory-II.
- Scale construct: the BDI-II is a 21-item patient-reported outcome measure of depressive symptoms' severity over the past two weeks.
- Scale items: 21.
- Scale range values: 0 to 3 for each item.
- Scale score: 0 (min)-63 (max), sum of the 21 items scores. Higher scores reflect greater severity of depressive symptoms.
Measured: From Baseline-Week 0 to average of Weeks 8 to 12
Efficacy: Difference in the STAXI-2-State Anger Subscale Score From Baseline to Average of Weeks 8 to 12
Change on the State-Trait Anger Expression Inventory 2 (STAXI-2) State Anger (SA), Trait Anger (TA) and Anger Expression Index (AEI) Subscales from Baseline to average of Weeks 8-12 between Vafidemstat and Placebo
- Construct: STAXI-2 is a 57-item patient-reported outcome measure of intensity and expression of anger as an emotional state: State Anger at that moment (how I feel right now), whereas Trait Anger reflects anger intensity and expression over a longer period of time (how I generally feel) and AEI measures how I generally behave when angry or furious. STAXI-2 was used in PORTICO as a measure of agitation and aggression
- Items: SA=15; TA=10; AEI=32 (in 4 subscales: AX-O=Anger Out; AX-I=Anger In; AC-O=Anger Control Out; AC-I=Anger Control In)
- Range values: 1-4 each item
- Subscale scores: sum of items. SA=15 min-60 max; TA=10 min-40 max; AEI=4 subscores 8 min-32 max each, combined as AEI=(AX-O+AX-I)-(AC-O+AC-I). Higher scores mean higher agitation and aggression
Measured: From Baseline-Week 0 to average of Weeks 8 to 12
Efficacy: Difference in the STAXI-2-Trait Anger Subscale Score From Baseline to Average of Weeks 8 to 12
Change on the State-Trait Anger Expression Inventory 2 (STAXI-2) State Anger (SA), Trait Anger (TA) and Anger Expression Index (AEI) Subscales from Baseline to average of Weeks 8-12 between Vafidemstat and Placebo
- Construct: STAXI-2 is a 57-item patient-reported outcome measure of intensity and expression of anger as an emotional state: State Anger at that moment (how I feel right now), whereas Trait Anger reflects anger intensity and expression over a longer period of time (how I generally feel) and AEI measures how I generally behave when angry or furious. STAXI-2 was used in PORTICO as a measure of agitation and aggression
- Items: SA=15; TA=10; AEI=32 (in 4 subscales: AX-O=Anger Out; AX-I=Anger In; AC-O=Anger Control Out; AC-I=Anger Control In)
- Range values: 1-4 each item
- Subscale scores: sum of items. SA=15 min-60 max; TA=10 min-40 max; AEI=4 subscores 8 min-32 max each, combined as AEI=(AX-O+AX-I)-(AC-O+AC-I). Higher scores mean higher agitation and aggression
Measured: From Baseline-Week 0 to average of Weeks 8 to 12
Efficacy: Difference in the STAXI-2-Anger Expression Index Subscale Score From Baseline to Average of Weeks 8 to 12
Change on the State-Trait Anger Expression Inventory 2 (STAXI-2) State Anger (SA), Trait Anger (TA) and Anger Expression Index (AEI) Subscales from Baseline to average of Weeks 8-12 between Vafidemstat and Placebo
- Construct: STAXI-2 is a 57-item patient-reported outcome measure of intensity and expression of anger as an emotional state: State Anger at that moment (how I feel right now), whereas Trait Anger reflects anger intensity and expression over a longer period of time (how I generally feel) and AEI measures how I generally behave when angry or furious. STAXI-2 was used in PORTICO as a measure of agitation and aggression
- Items: SA=15; TA=10; AEI=32 (in 4 subscales: AX-O=Anger Out; AX-I=Anger In; AC-O=Anger Control Out; AC-I=Anger Control In)
- Range values: 1-4 each item
- Subscale scores: sum of items. SA=15 min-60 max; TA=10 min-40 max; AEI=4 subscores 8 min-32 max each, combined as AEI=(AX-O+AX-I)-(AC-O+AC-I). Higher scores mean higher agitation and aggression
Measured: From Baseline-Week 0 to average of Weeks 8 to 12
Efficacy: Difference in the STAI-State Anxiety From Baseline to Average of Weeks 8 to 12
Change over time on the STAI-State Anxiety and Trait Anxiety Raw Scores, from Baseline to average of Weeks 8 to 12, between active treatment arm (Vafidemstat 1.2 mg) and Placebo arm (full analysis set).
- Full scale name: State-Trait Anxiety Inventory.
- Scale construct: STAI is a 40-item patient-reported outcome measuring two types of anxiety: state-anxiety or current state anxiety (20 items), or trait-anxiety or general anxiety level as a personal characteristic (20 items).
- Scale items: 40 items. 20 items measure state-anxiety (current), 20 items measure trait-anxiety (personal characteristic).
- Scale range values: 1 to 4 per item. State-anxiety items: 1= Not At All, 4=Very Much So. Trait-anxiety items: 1=Almost Never, 4=Almost Always.
- Scale score: 20 (min)-80 (max) as the sum of the 20 items scores for state-anxiety or trait-anxiety independently. State-anxiety: higher scores reflect higher current anxiety. Trait-anxiety, higher scores reflect greater tendency towards anxiety.
Measured: From Baseline-Week 0 to average of Weeks 8 to 12
Efficacy: Difference in the CGI-S A/A Over Time (From Baseline to Week 12)
Change on the CGI-S A/A from Baseline to Week 12, between the active treatment arm (Vafidemstat 1.2 mg) and the placebo arm (full analysis set).
- Full scale name: Clinical Global Impression-Severity focused on Agitation/Aggression
- Scale construct: the CGI S-A/A is a clinician's global rating of the BPD patients' severity of agitation and aggression symptoms at the time of evaluation.
- Scale items: 1.
- Scale range values: 0 to 7. Higher scores reflect greater severity of BPD-related agitation and agression symptoms.
- Scale score: 0 (min) - 7 (max).
Measured: From Baseline-Week 0 to Week 12
Efficacy - Difference in the BPDCL-Total Score Over Time (From Baseline to Week 12)
Change on the BPDCL-Total Score from Baseline to Week 12, between the active treatment arm (Vafidemstat 1.2 mg) and the placebo arm (full analysis set).
- Full scale name: Borderline Personality Disorder Checklist.
- Scale construct: the BPDCL is a patient-reported outcome measure of BPD symptoms' severity over the past 2 weeks. The Total Score is a global score representing overall BPD symptom burden.
- Scale items: 47 items.
- Scale range values: 1 to 5 for each item.
- Scale score: Total Score=47 (min) - 235 (max) as the sum of the 47 items scores. Higher scores reflect greater severity of BPD symptoms.
Measured: Over time: from Baseline-Week 0 to Week 12
Efficacy: Difference in the BEST-Total Score Over Time (From Baseline to Week 12)
Change on the BEST-Total Score from Baseline to Week 12, between the active treatment arm (Vafidemstat 1.2 mgr) and the Placebo arm (full analysis set).
- Full scale name: Borderline Evaluation of Severity Over Time.
- Scale construct: the BEST is a 15-item patient-reported outcome measure of BPD symptoms' severity and coping responses over the past 2 weeks.
- Scale items: 15 items comprising 3 subscales (subscale A-Thoughts and Feelings=8 items; subscale B-Negative Behaviors=4 items; subscale C-Positive Behaviors=3 items).
- Scale range values: 1 to 5 for each item.
- Scale score: 12 (min) - 72 (max) as per the formula 15 + A + B - C. Higher scores reflect greater severity of BPD symptoms.
Measured: Over time: from Baseline-Week 0 to Week 12
Efficacy - Difference in the BDI-II Total Score Over Time (From Baseline to Week 12)
Change on the BDI-II-Total Score from Baseline to Week 12, between the active treatment arm (Vafidemstat 1.2 mg) and the Placebo arm (full analysis set).
- Full scale name: Beck Depression Inventory-II.
- Scale construct: the BDI-II is a 21-item patient-reported outcome measure of depressive symptoms' severity over the past two weeks.
- Scale items: 21.
- Scale range values: 0 to 3 for each item.
- Scale score: 0 (min)-63 (max), sum of the 21 items scores. Higher scores reflect greater severity of depressive symptoms.
Measured: Over time: from Baseline-Week 0 to Week 12
Efficacy: Difference in the STAXI 2-State Anger Subscale Score Over Time (From Baseline to Week 12)
Change on the State-Trait Anger Expression Inventory 2 (STAXI-2) State Anger (SA), Trait Anger (TA) and Anger Expression Index (AEI) Subscales from Baseline to Week 12 between Vafidemstat and Placebo
- Construct: STAXI-2 is a 57-item patient-reported outcome measure of intensity and expression of anger as an emotional state: State Anger, at that moment (how I feel right now), whereas Trait Anger reflects anger intensity and expression over a longer period of time (how I generally feel) and AEI measures how I generally behave when angry or furious. STAXI-2 was used in PORTICO as a measure of agitation and aggression
- Items: SA=15; TA=10; AEI=32 (in 4 subscales: AX-O=Anger Out; AX-I=Anger In; AC-O=Anger Control Out; AC-I=Anger Control In)
- Range values: 1-4 each item
- Subscale scores: sum of items. SA=15 min-60 max; TA=10 min-40 max; AEI=4 subscores 8 min-32 max each, combined as AEI=(AX-O+AX-I)-(AC-O+AC-I). Higher scores mean higher agitation and aggression
Measured: Over time: from Baseline-Week 0 to Week 12
Efficacy: Difference in the STAXI 2-Trait Anger Subscale Score Over Time (From Baseline to Week 12)
Change on the State-Trait Anger Expression Inventory 2 (STAXI-2) State Anger (SA), Trait Anger (TA) and Anger Expression Index (AEI) Subscales from Baseline to Week 12 between Vafidemstat and Placebo
- Construct: STAXI-2 is a 57-item patient-reported outcome measure of intensity and expression of anger as an emotional state: State Anger, at that moment (how I feel right now), whereas Trait Anger reflects anger intensity and expression over a longer period of time (how I generally feel) and AEI measures how I generally behave when angry or furious. STAXI-2 was used in PORTICO as a measure of agitation and aggression
- Items: SA=15; TA=10; AEI=32 (in 4 subscales: AX-O=Anger Out; AX-I=Anger In; AC-O=Anger Control Out; AC-I=Anger Control In)
- Range values: 1-4 each item
- Subscale scores: sum of items. SA=15 min-60 max; TA=10 min-40 max; AEI=4 subscores 8 min-32 max each, combined as AEI=(AX-O+AX-I)-(AC-O+AC-I). Higher scores mean higher agitation and aggression
Measured: Over time: from Baseline-Week 0 to Week 12
Efficacy: Difference in the STAXI 2-Anger Expression Index Subscale Score Over Time (From Baseline to Week 12)
Change on the State-Trait Anger Expression Inventory 2 (STAXI-2) State Anger (SA), Trait Anger (TA) and Anger Expression Index (AEI) Subscales from Baseline to Week 12 between Vafidemstat and Placebo
- Construct: STAXI-2 is a 57-item patient-reported outcome measure of intensity and expression of anger as an emotional state: State Anger, at that moment (how I feel right now), whereas Trait Anger reflects anger intensity and expression over a longer period of time (how I generally feel) and AEI measures how I generally behave when angry or furious. STAXI-2 was used in PORTICO as a measure of agitation and aggression
- Items: SA=15; TA=10; AEI=32 (in 4 subscales: AX-O=Anger Out; AX-I=Anger In; AC-O=Anger Control Out; AC-I=Anger Control In)
- Range values: 1-4 each item
- Subscale scores: sum of items. SA=15 min-60 max; TA=10 min-40 max; AEI=4 subscores 8 min-32 max each, combined as AEI=(AX-O+AX-I)-(AC-O+AC-I). Higher scores mean higher agitation and aggression
Measured: Over time: from Baseline-Week 0 to Week 12
Efficacy: Difference in the STAI-State Anxiety Over Time (From Baseline to Week 12)
Change over time on the STAI-State Anxiety and Trait Anxiety Raw Scores, from Baseline to Week 12, between active treatment arm (Vafidemstat 1.2 mg) and Placebo arm (full analysis set).
- Full scale name: State-Trait Anxiety Inventory.
- Scale construct: STAI is a 40-item patient-reported outcome measuring two types of anxiety: state-anxiety or current state anxiety (20 items), or trait-anxiety or general anxiety level as a personal characteristic (20 items).
- Scale items: 40 items. 20 items measure state-anxiety (current), 20 items measure trait-anxiety (personal characteristic).
- Scale range values: 1 to 4 per item. State-anxiety items: 1= Not At All, 4=Very Much So. Trait-anxiety items: 1=Almost Never, 4=Almost Always.
- Scale score: 20 (min)-80 (max) as the sum of the 20 items scores for state-anxiety or trait-anxiety independently. State-anxiety: higher scores reflect higher current anxiety. Trait-anxiety, higher scores reflect greater tendency towards anxiety.
Measured: Over time: from Baseline-Week 0 to Week 12
Efficacy: Difference in the STAI-Trait Anxiety Over Time (From Baseline to Week 12)
Change over time on the STAI-State Anxiety and Trait Anxiety Raw Scores, from Baseline to Week 12, between active treatment arm (Vafidemstat 1.2 mg) and Placebo arm (full analysis set).
- Full scale name: State-Trait Anxiety Inventory.
- Scale construct: STAI is a 40-item patient-reported outcome measuring two types of anxiety: state-anxiety or current state anxiety (20 items), or trait-anxiety or general anxiety level as a personal characteristic (20 items).
- Scale items: 40 items. 20 items measure state-anxiety (current), 20 items measure trait-anxiety (personal characteristic).
- Scale range values: 1 to 4 per item. State-anxiety items: 1= Not At All, 4=Very Much So. Trait-anxiety items: 1=Almost Never, 4=Almost Always.
- Scale score: 20 (min)-80 (max) as the sum of the 20 items scores for state-anxiety or trait-anxiety independently. State-anxiety: higher scores reflect higher current anxiety. Trait-anxiety, higher scores reflect greater tendency towards anxiety.
Measured: Over time: from Baseline-Week 0 to Week 12
Safety: Number of Subjects Experiencing Treatment-emergent Adverse Events (TEAEs)
Number of subjects experiencing treatment-emergent adverse events (TEAEs) in the active treatment arm (Vafidemstat 1.2 mg) and the placebo arm (safety analysis set population).
Study discontinuation and study drug withdrawal are equivalent: all subjects withdrawn from study drug were discontinued from the study.
AESI: TEAEs of Special Interest. TEAEs as per severity of the adverse event: mild / moderate / severe. TEAEs as per outcome of the adverse event at the end of the trial: resolved / not resolved / resolving / resolved with sequelae / outcome=death / outcome=unknown.
Measured: From Baseline-Week 0 to Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start26 Mar 2021
- Primary completion30 Oct 2023
- Study completion13 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oryzon Genomics S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Ropacki, MD, Study director, Oryzon Genomics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932291
- Sponsor's protocol ID
- CL07-ORY-2001
- Status last verified
- Feb 2025
- First submitted
- 12 Apr 2021
- Last updated
- 5 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "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)"
- ClinicalTrials.gov ID
- NCT04932291
- Acronym / sponsor ID
- CL07-ORY-2001
- Conditions
- Borderline Personality Disorder
- Keywords
- Borderline personality disorder, vafidemstat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Oryzon Genomics S.A.Industry (pharma, biotech, devices)
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 13 Nov 2023 (actual)
- First posted
- 21 Jun 2021 (actual)
- Results
- Posted 5 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PORTICO is a Phase IIb study to evaluate the efficacy and safety of vafidemstat in an adult borderline personality disorder (BPD) population.
Detailed description
PORTICO is 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vafidemstat 1.2mg | Experimental | Drug: vafidemstatVafidemstat is administered as capsules. |
| placebo | Placebo comparator | Drug: PlaceboPlacebo is administered as capsules. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vafidemstatAlso: ORY-20011.2mg capsule | Drug | vafidemstat 1.2mg |
| Placeboplacebo capsule | Drug | placebo |
Primary outcome
Efficacy: Difference in the CGI-S A/A From Baseline to Average of Weeks 8 to 12
Time frame: From Baseline-Week 0 to average of Weeks 8 to 12
Change on the CGI-S A/A from Baseline to average of Weeks 8 to 12, between the active treatment arm (Vafidemstat 1.2 mg) and the placebo arm (full analysis set). * Full scale name: Clinical Global Impression-Severity focused on Agitation/Aggression * Scale construct: the CGI-S A/A is a clinician's global rating of the BPD patients' severity of agitation and aggression symptoms at the time of evaluation. * Scale items: 1. * Scale range values: 0 to 7. Higher scores reflect greater severity of BPD-related agitation and agression symptoms. * Scale score: 0 (min) - 7 (max).
Efficacy: Difference in the BPDCL-Total Score From Baseline to Average of Weeks 8 to 12
Time frame: From Baseline-Week 0 to average of Weeks 8 to 12
Change on the BPDCL-Total Score from Baseline to average of Weeks 8 to 12, between the active treatment arm (Vafidemstat 1.2 mg) and the placebo arm (full analysis set). * Full scale name: Borderline Personality Disorder Checklist. * Scale construct: the BPDCL is a patient-reported outcome measure of BPD symptoms' severity over the past 2 weeks. The Total Score is a global score representing overall BPD symptom burden. * Scale items: 47 items. * Scale range values: 1 to 5 for each item. * Scale score: Total Score=47 (min) - 235 (max) as the sum of the 47 items scores. Higher scores reflect greater severity of BPD symptoms.
16 secondary outcomes
Efficacy: Difference in the BEST-Total Score From Baseline to Average of Weeks 8 to 12
Time frame: From Baseline-Week 0 to average of Weeks 8 to 12
Efficacy: Difference in the BDI-II Total Score From Baseline to Average of Weeks 8 to 12
Time frame: From Baseline-Week 0 to average of Weeks 8 to 12
Efficacy: Difference in the STAXI-2-State Anger Subscale Score From Baseline to Average of Weeks 8 to 12
Time frame: From Baseline-Week 0 to average of Weeks 8 to 12
Efficacy: Difference in the STAXI-2-Trait Anger Subscale Score From Baseline to Average of Weeks 8 to 12
Time frame: From Baseline-Week 0 to average of Weeks 8 to 12
Efficacy: Difference in the STAXI-2-Anger Expression Index Subscale Score From Baseline to Average of Weeks 8 to 12
Time frame: From Baseline-Week 0 to average of Weeks 8 to 12
Efficacy: Difference in the STAI-State Anxiety From Baseline to Average of Weeks 8 to 12
Time frame: From Baseline-Week 0 to average of Weeks 8 to 12
Efficacy: Difference in the CGI-S A/A Over Time (From Baseline to Week 12)
Time frame: From Baseline-Week 0 to Week 12
Efficacy - Difference in the BPDCL-Total Score Over Time (From Baseline to Week 12)
Time frame: Over time: from Baseline-Week 0 to Week 12
Efficacy: Difference in the BEST-Total Score Over Time (From Baseline to Week 12)
Time frame: Over time: from Baseline-Week 0 to Week 12
Efficacy - Difference in the BDI-II Total Score Over Time (From Baseline to Week 12)
Time frame: Over time: from Baseline-Week 0 to Week 12
Efficacy: Difference in the STAXI 2-State Anger Subscale Score Over Time (From Baseline to Week 12)
Time frame: Over time: from Baseline-Week 0 to Week 12
Efficacy: Difference in the STAXI 2-Trait Anger Subscale Score Over Time (From Baseline to Week 12)
Time frame: Over time: from Baseline-Week 0 to Week 12
Efficacy: Difference in the STAXI 2-Anger Expression Index Subscale Score Over Time (From Baseline to Week 12)
Time frame: Over time: from Baseline-Week 0 to Week 12
Efficacy: Difference in the STAI-State Anxiety Over Time (From Baseline to Week 12)
Time frame: Over time: from Baseline-Week 0 to Week 12
Efficacy: Difference in the STAI-Trait Anxiety Over Time (From Baseline to Week 12)
Time frame: Over time: from Baseline-Week 0 to Week 12
Safety: Number of Subjects Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: From Baseline-Week 0 to Week 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Ropacki, MD study director
Oryzon Genomics
21 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing vafidemstat in people with Borderline Personality Disorder, run by Oryzon Genomics S.A. at 21 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Bulgaria, Serbia, Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: Difference in the CGI-S A/A From Baseline to Average of Weeks 8 to 12 (time frame: From Baseline-Week 0 to average of Weeks 8 to 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.