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Undersøgelse for at teste effektiviteten og sikkerheden af ​​Vafidemstat i voksne borderline personlighedsforstyrrelser population

4. maj 2026 opdateret af: Oryzon Genomics S.A.

"Et dobbeltblindt, randomiseret, placebo-kontrolleret, adaptivt 14-ugers fase IIb-forsøg for at evaluere effektiviteten og sikkerheden af ​​Vafidemstat i en befolkningsgruppe med borderline personlighedsforstyrrelse (BPD) hos voksne (PORTICO)"

PORTICO er et fase IIb-studie til at evaluere effektiviteten og sikkerheden af ​​vafidemstat i en voksen borderline personlighedsforstyrrelse (BPD) population.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

PORTICO er et dobbeltblindt, randomiseret, placebokontrolleret, adaptivt 14-ugers fase IIb-forsøg til evaluering af effektiviteten og sikkerheden af ​​vafidemstat i en befolkning med borderline personlighedsforstyrrelser (BPD) hos voksne.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

211

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Bulgarien
      • Varna, Bulgarien, 9000
        • DCC "Mladost-M" Ltd, Psychiatr
    • Sofia-Grad
      • Sofia, Sofia-Grad, Bulgarien, 1680
        • Medical Center Intermedika
      • Sofia, Sofia-Grad, Bulgarien, 9000
        • Medical Center Hera EOOD - Psychiatry Office
  • Forenede Stater
    • California
      • Oceanside, California, Forenede Stater, 92056
        • Excell Research, Inc.
      • Oceanside, California, Forenede Stater, 92056
        • Excell Research Inc
    • Florida
      • Hialeah, Florida, Forenede Stater, 33012
        • New Life Medical Research Center
      • Miami, Florida, Forenede Stater, 33165
        • Phoenix Medical Research LLC
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637-1426
        • University of Chicago Institutional Review Board
      • Elgin, Illinois, Forenede Stater, 60123
        • Revive Research Institute
    • Massachusetts
      • Watertown, Massachusetts, Forenede Stater, 02472
        • Adams Clinical Trials, LLC
    • New Jersey
      • Cherry Hill, New Jersey, Forenede Stater, 08002
        • Center for Emotioal Fitness
    • New York
      • Cedarhurst, New York, Forenede Stater, 11516
        • Neurobehavioral Research Inc.
      • New York, New York, Forenede Stater, 10128
        • The Medical Research Network
    • Washington
      • Everett, Washington, Forenede Stater, 98201
        • Core Clinical Research
  • Serbien
      • Belgrade, Serbien, 11000
        • Clinical Center of Serbia
      • Belgrade, Serbien, 11000
        • Clinic for psychiatric disorders "Laza Lazarevic"
      • Kragujevac, Serbien, 3400
        • Clinical center Kragujevac
  • Spanien
      • Barcelona, Spanien, 08035
        • Hospital Vall d'Hebron
      • Madrid, Spanien, 28040
        • Hospital Clinico San Carlos
  • Tyskland
      • Berlin, Tyskland, 10629
        • Emovis GmbH
    • Bavaria
      • München, Bavaria, Tyskland, 80336
        • Klinik fur Psychiatrie und Psychotherapie, LMU

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Primære inklusionskriterier:

  1. Mænd og kvinder i alderen 18-65 år.
  2. DSM-5 diagnostiske kriterier for BPD mindst 3 måneder før screeningsbesøget. Den mini-internationale neuropsykiatriske samtale (MINI) vil blive administreret ved screening for at bekræfte BPD-diagnosen, samt for at bekræfte, at forsøgspersonen ikke opfylder andre relevante eksklusionskriterier.
  3. Agitation-Aggression Psykiatrisk Inventory-Clinician Report (AAPI-CR) Agitation & Aggression (A/A) subskala-score på > 16 (alvorlighed x frekvens) opsummeret på tværs af de fire (4) elementer, der omfatter A/A-subskalaen, og summen af A/A-underskalaens sværhedsgradscore > 6.
  4. Ambulant kendt af stedet eller investigator og har været behandlet af stedet eller investigator i mindst de sidste 3 måneder forud for screeningsbesøget.
  5. Stabilt bomiljø i > 6 måneder før screeningsbesøget.
  6. Body mass index (BMI) på mindst 18,5 kg/m2, men ikke mere end 35 kg/m2.
  7. Villig og i stand til at overholde de forbud, begrænsninger og krav, der er specificeret i denne protokol.
  8. Ellers sund og medicinsk stabil baseret på sygehistorie.
  9. Kliniske og neurologiske undersøgelser og laboratorietests samt 12-aflednings-EKG udført under screening, der bekræfter, at forsøgspersonen er sund og medicinsk stabil.
  10. Kunne læse og skrive flydende og skal have tilstrækkelig høre- og synsstyrke til at gennemføre den påkrævede test, der er beskrevet i denne protokol.
  11. Stabile i deres tilladte regime af baggrundsterapi i henhold til lægemiddelmærkning for samtidig medicin ved screeningsbesøget, og de bør opretholde behandlingen under hele undersøgelsen og ikke påbegynde nogen forbudt medicin under forsøget. Forsøgspersonerne bør acceptere at informere deres undersøgelseslæge om eventuelle medicinændringer under hele forsøget.
  12. Tilmeldte forsøgspersoner skal opretholde deres præ-screening psykoterapi tidsplan under hele forsøgets varighed. Det vil sige, at forsøgspersoner, der modtager psykoterapi, skal have den startet mindst 3 måneder før screeningsbesøget og forblive i psykoterapi under hele forsøget. Forsøgspersoner, der ikke modtager psykoterapi, bør ikke påbegynde psykoterapi under forsøget.

  13. Fertile mandlige og kvindelige forsøgspersoner skal bruge højeffektiv prævention, fra screeningsbesøget indtil 30 dage efter sidste dosis af IMP, defineret som:

    En metode med mindre end 1 % fejlrate (f.eks. permanent sterilisering, hormonimplantater, hormoninjektioner, nogle intrauterine anordninger eller en vasektomiseret partner) ELLER brugen af ​​to præventionsmetoder (f.eks. én barrieremetode [kondom, diafragma eller cervikal/ vault caps] med sæddræbende middel og et hormonelt præventionsmiddel [f.eks. kombinerede orale præventionsmidler, plaster, vaginal ring, injicerbare og implantater])

  14. Kvindelige forsøgspersoner i den fødedygtige alder skal have en negativ uringraviditetstest ved screening og baseline.
  15. Underskrevet informeret samtykke fra deltageren forud for påbegyndelsen af ​​en undersøgelsesspecifik procedure.

Primære udelukkelseskriterier

  1. DSM-5 diagnose af intellektuelt handicap, autismespektrumforstyrrelse, skizofreni, skizoaffektiv lidelse, bipolar lidelse (eller relaterede lidelser) eller svær depressiv lidelse (MDD) med psykose.
  2. Nuværende DSM-5 diagnose af adfærdsforstyrrelse, anorexia nervosa, bulimia nervosa, binge-eating disorder, oppositionel trodslidelse, paranoid personlighedsforstyrrelse eller obsessiv-kompulsiv lidelse.
  3. Nuværende DSM-5 diagnose af panikangst eller posttraumatisk stresslidelse (PTSD). Men forsøgspersoner med PTSD, generaliseret angstlidelse (GAD), social angstlidelse (SAD), MDD uden psykose, opmærksomhedsunderskud hyperaktivitetsforstyrrelse (ADHD) er kvalificerede, hvis symptomerne har været stabile i mindst 90 dage før screeningbesøget, disse lidelser er ikke det primære fokus for behandlingen, ændringer i enhver behandling for disse lidelser vil sandsynligvis ikke være nødvendige i undersøgelsens varighed, og efter investigators mening vil disse lidelser ikke forstyrre vurderingen og/eller nøjagtigheden af ​​undersøgelsen endepunkter.
  4. Anamnese med moderat eller svær stof- eller alkoholmisbrug ifølge DSM-5, med undtagelse af nikotin og koffein, inden for 6 måneder før screening.
  5. Brug af ulovlige stoffer i mindst en uge før screening og forsøgspersoner, der ikke er villige til at afstå fra brug af disse stoffer under undersøgelsen.
  6. Hospitalsindlæggelse eller medicinændring af en eller anden grund, to måneder før screeningsbesøget eller i screeningsperioden, der gør forsøgspersonen medicinsk eller mentalt uegnet til forsøgsdeltagelse.
  7. Klinisk signifikant, fremskreden eller ustabil sygdom, der sandsynligvis vil resultere i hurtig forværring af forsøgspersonens tilstand eller påvirke deres sikkerhed under undersøgelsen.
  8. Positive resultater for tuberkulose, humant immundefektvirus (HIV), hepatitis C eller hepatitis B serologi opnået ved screeningsbesøget.
  9. Ukontrolleret hypo- eller hyperthyroidisme ved screeningsbesøg, baseret på laboratorieparametre.
  10. Klinisk signifikant infektion inden for de foregående 30 dage.
  11. Kronisk medicinindtagelse af specifik forbudt medicin
  12. Esketamin inden for de seneste 90 dage før screeningsbesøget.
  13. Elektrokonvulsiv terapi (ECT) eller transkraniel magnetisk stimulation (TMS) inden for de seneste 90 dage før screeningsbesøget.
  14. Ethvert regelmæssigt indtag af medicin, der virker direkte på centralnervesystemet, som efterforskeren anser for relevant for undersøgelsen.
  15. Medlem af eller nærmeste familie til studiepersonalet eller underordnet nogen af ​​studiepersonalet.
  16. Tilmelding til et andet forsøgsstudie eller indtagelse af forsøgslægemiddel inden for de foregående 3 måneder.
  17. Selvmordsforsøg inden for 6 måneder før screeningsbesøget eller betydelig risiko for selvmord.
  18. Enhver tilstand, der efter investigatorens mening gør emnet uegnet til at indgå i undersøgelsen.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: vafidemstat 1,2mg
Vafidemstat indgives som kapsler.
Medicin: vafidemstat
1,2 mg kapsel
Andre navne:
  • ORY-2001
Placebo komparator: placebo
Placebo indgives som kapsler.
Medicin: Placebo
placebo kapsel

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Efficacy: Difference in the CGI-S A/A From Baseline to Average of Weeks 8 to 12
Tidsramme: 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).
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
Tidsramme: 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.
From Baseline-Week 0 to average of Weeks 8 to 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Efficacy: Difference in the BEST-Total Score From Baseline to Average of Weeks 8 to 12
Tidsramme: From Baseline-Week 0 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
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
Tidsramme: From Baseline-Week 0 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.
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
Tidsramme: From Baseline-Week 0 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
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
Tidsramme: From Baseline-Week 0 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
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
Tidsramme: From Baseline-Week 0 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
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
Tidsramme: From Baseline-Week 0 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.
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)
Tidsramme: From Baseline-Week 0 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).
From Baseline-Week 0 to Week 12
Efficacy - Difference in the BPDCL-Total Score Over Time (From Baseline to Week 12)
Tidsramme: Over time: from Baseline-Week 0 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.
Over time: from Baseline-Week 0 to Week 12
Efficacy: Difference in the BEST-Total Score Over Time (From Baseline to Week 12)
Tidsramme: Over time: from Baseline-Week 0 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.
Over time: from Baseline-Week 0 to Week 12
Efficacy - Difference in the BDI-II Total Score Over Time (From Baseline to Week 12)
Tidsramme: Over time: from Baseline-Week 0 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.
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)
Tidsramme: Over time: from Baseline-Week 0 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
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)
Tidsramme: Over time: from Baseline-Week 0 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
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)
Tidsramme: Over time: from Baseline-Week 0 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
Over time: from Baseline-Week 0 to Week 12
Efficacy: Difference in the STAI-State Anxiety Over Time (From Baseline to Week 12)
Tidsramme: Over time: from Baseline-Week 0 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.
Over time: from Baseline-Week 0 to Week 12
Efficacy: Difference in the STAI-Trait Anxiety Over Time (From Baseline to Week 12)
Tidsramme: Over time: from Baseline-Week 0 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.
Over time: from Baseline-Week 0 to Week 12
Safety: Number of Subjects Experiencing Treatment-emergent Adverse Events (TEAEs)
Tidsramme: From Baseline-Week 0 to Week 14

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.
From Baseline-Week 0 to Week 14

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Oryzon Genomics S.A.

Efterforskere

  • Studieleder: Michael Ropacki, MD, Oryzon Genomics

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

26. marts 2021

Primær færdiggørelse (Faktiske)

30. oktober 2023

Studieafslutning (Faktiske)

13. november 2023

Datoer for studieregistrering

Først indsendt

12. april 2021

Først indsendt, der opfyldte QC-kriterier

11. juni 2021

Først opslået (Faktiske)

21. juni 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. maj 2026

Sidst verificeret

1. februar 2025

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CL07-ORY-2001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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