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Studie for å teste effektiviteten og sikkerheten til Vafidemstat i voksen borderline personlighetsforstyrrelse.

4. mai 2026 oppdatert av: Oryzon Genomics S.A.

"En dobbeltblind, randomisert, placebokontrollert, adaptiv 14-ukers fase IIb-studie for å evaluere effektiviteten og sikkerheten til Vafidemstat i en populasjon med borderline personlighetsforstyrrelse (BPD) for voksne (PORTICO)"

PORTICO er en fase IIb-studie for å evaluere effektiviteten og sikkerheten til vafidemstat i en voksen populasjon med borderline personlighetsforstyrrelse (BPD).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

PORTICO er en dobbeltblind, randomisert, placebokontrollert, adaptiv 14-ukers fase IIb-studie for å evaluere effekten og sikkerheten til vafidemstat i en voksen populasjon med borderline personlighetsforstyrrelse (BPD).

Studietype

Intervensjonell

Registrering (Faktiske)

211

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Beskrivelse

Hovedinkluderingskriterier:

  1. Menn og kvinner 18-65 år.
  2. DSM-5 diagnostiske kriterier for BPD minst 3 måneder før screeningbesøket. Det mini-internasjonale nevropsykiatriske intervjuet (MINI) vil bli administrert ved screening for å bekrefte BPD-diagnose, samt for å bekrefte at personen ikke oppfyller andre relevante eksklusjonskriterier.
  3. Agitation-Aggression Psykiatrisk Inventory-Clinician Report (AAPI-CR) Agitation & Aggression (A/A) subskala-score på > 16 (alvorlighet x frekvens) summert over de fire (4) elementene som omfatter A/A-subskalaen, og summen av A/A-subskalaens alvorlighetsgradscore > 6.
  4. Poliklinisk kjent for stedet eller etterforskeren og har blitt behandlet av stedet eller etterforskeren i minst de siste 3 månedene før screeningbesøket.
  5. Stabilt bomiljø i > 6 måneder før Screening-besøket.
  6. Kroppsmasseindeks (BMI) på minst 18,5 kg/m2, men ikke mer enn 35 kg/m2.
  7. Villig og i stand til å overholde forbudene, restriksjonene og kravene spesifisert i denne protokollen.
  8. Ellers frisk, og medisinsk stabil basert på sykehistorie.
  9. Kliniske og nevrologiske undersøkelser og laboratorietester, samt 12-avlednings-EKG utført under screening som bekrefter at personen er frisk og medisinsk stabil.
  10. Kunne lese og skrive flytende og må ha tilstrekkelig hørsel og synsstyrke for å fullføre den nødvendige testingen som er skissert i denne protokollen.
  11. Stabile i sitt tillatte regime av bakgrunnsterapi i henhold til legemiddelmerking for samtidige medisiner ved screeningbesøket, og de bør opprettholde behandlingen gjennom hele studien og ikke starte noen forbudte medisiner under forsøket. Forsøkspersonene bør samtykke i å informere studielegen om eventuelle medisinendring gjennom hele forsøket.
  12. Påmeldte forsøkspersoner må opprettholde sin psykoterapiplan før screening gjennom hele prøveperioden. Det vil si at forsøkspersoner som mottar psykoterapi må ha det startet minst 3 måneder før screeningbesøket og forbli i psykoterapi gjennom hele forsøket. Personer som ikke mottar psykoterapi bør ikke starte psykoterapi under forsøket.

  13. Fertile mannlige og kvinnelige forsøkspersoner må bruke svært effektiv prevensjon, fra screeningbesøket til 30 dager etter siste dose av IMP, definert som:

    En metode med mindre enn 1 % feilrate (f.eks. permanent sterilisering, hormonimplantater, hormoninjeksjoner, noen intrauterine enheter eller en vasektomisert partner) ELLER bruk av to prevensjonsmetoder (f.eks. én barrieremetode [kondom, diafragma eller cervical/ hvelvhetter] med spermicid og ett hormonelt prevensjonsmiddel [f.eks. kombinerte orale prevensjonsmidler, plaster, vaginalring, injiserbare og implantater])

  14. Kvinnelige forsøkspersoner i fertil alder må ha en negativ uringraviditetstest ved screening og baseline.
  15. Signert informert samtykke fra deltaker før oppstart av en studiespesifikk prosedyre.

Hovedeksklusjonskriterier

  1. DSM-5 diagnose av intellektuell funksjonshemming, autismespekterforstyrrelse, schizofreni, schizoaffektiv lidelse, bipolar lidelse (eller relaterte lidelser) eller alvorlig depressiv lidelse (MDD) med psykose.
  2. Gjeldende DSM-5-diagnose for atferdsforstyrrelse, anorexia nervosa, bulimia nervosa, overspisingsforstyrrelse, opposisjonell trassig lidelse, paranoid personlighetsforstyrrelse eller tvangslidelse.
  3. Gjeldende DSM-5 diagnose av panikklidelse eller posttraumatisk stresslidelse (PTSD). Personer med PTSD, generalisert angstlidelse (GAD), sosial angstlidelse (SAD), MDD uten psykose, oppmerksomhetsunderskudd hyperaktivitetsforstyrrelse (ADHD) er kvalifisert dersom symptomene har vært stabile i minst 90 dager før screeningbesøket, disse lidelser er ikke det primære fokuset for behandlingen, endringer i enhver behandling for disse lidelsene vil sannsynligvis ikke være nødvendig i løpet av studiens varighet, og etter etterforskerens mening vil disse lidelsene ikke forstyrre vurderingen og/eller nøyaktigheten av studien endepunkter.
  4. Anamnese med moderat eller alvorlig stoff- eller alkoholbruksforstyrrelse i henhold til DSM-5, med unntak av nikotin og koffein, innen 6 måneder før screening.
  5. Bruk av ulovlige stoffer i minst en uke før screening og forsøkspersoner som ikke vil avstå fra bruk av disse stoffene under studien.
  6. Sykehusinnleggelse eller medisinendring av en eller annen grunn, to måneder før screeningbesøket eller i løpet av screeningsperioden, som gjør forsøkspersonen medisinsk eller mentalt uegnet for prøvedeltakelse.
  7. Klinisk signifikant, avansert eller ustabil sykdom som sannsynligvis vil resultere i rask forverring av pasientens tilstand eller påvirke deres sikkerhet under studien.
  8. Positive resultater for tuberkulose, humant immunsviktvirus (HIV), hepatitt C eller hepatitt B-serologi oppnådd ved screeningbesøket.
  9. Ukontrollert hypo- eller hypertyreose ved screeningbesøk, basert på laboratorieparametre.
  10. Klinisk signifikant infeksjon i løpet av de siste 30 dagene.
  11. Kronisk medikamentinntak av spesifikke forbudte medisiner
  12. Esketamin de siste 90 dagene før screeningbesøket.
  13. Elektrokonvulsiv terapi (ECT) eller transkraniell magnetisk stimulering (TMS) de siste 90 dagene før screeningbesøket.
  14. Ethvert regelmessig inntak av medisiner som virker direkte på sentralnervesystemet som etterforskeren anser som relevant for studien.
  15. Medlem eller nærmeste familie til studiepersonellet eller underordnet noen av studiepersonellet.
  16. Innmelding til en annen undersøkelsesstudie eller inntak av undersøkelseslegemiddel i løpet av de siste 3 månedene.
  17. Selvmordsforsøk innen 6 måneder før screeningbesøket eller betydelig risiko for selvmord.
  18. Enhver tilstand som etter utrederens mening gjør emnet uegnet for inkludering i studien.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: vafidemstat 1,2mg
Vafidemstat administreres som kapsler.
Legemiddel: vafidemstat
1,2 mg kapsel
Andre navn:
  • ORY-2001
Placebo komparator: placebo
Placebo gis som kapsler.
Legemiddel: Placebo
placebo kapsel

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Oryzon Genomics S.A.

Etterforskere

  • Studieleder: Michael Ropacki, MD, Oryzon Genomics

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

26. mars 2021

Primær fullføring (Faktiske)

30. oktober 2023

Studiet fullført (Faktiske)

13. november 2023

Datoer for studieregistrering

Først innsendt

12. april 2021

Først innsendt som oppfylte QC-kriteriene

11. juni 2021

Først lagt ut (Faktiske)

21. juni 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. mai 2026

Sist bekreftet

1. februar 2025

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CL07-ORY-2001

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere