Undersøgelse for at vurdere sikkerhed og effektivitet af langsomt stigende dosis og fødevareeffekt af KarXT hos deltagere med skizofreni
18. juni 2026 opdateret af: Karuna Therapeutics, Inc., a Bristol Myers Squibb company
En fase 3b, åben-label, multicenter, to-perioders, langsom titrering og fødevareeffektundersøgelse for at vurdere sikkerheden og effektiviteten af KarXT hos deltagere med DSM-5 skizofreni
Formålet med denne undersøgelse er at vurdere sikkerheden og effekten af langsomt stigende dosis og fødevareeffekt af KarXT hos voksne deltagere med skizofreni.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
173
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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California
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Los Alamitos, California, Forenede Stater, 90720-3118
- Local Institution - 0002
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Riverside, California, Forenede Stater, 92506-3257
- Local Institution - 0004
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Florida
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Hollywood, Florida, Forenede Stater, 33024
- Local Institution - 0006
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Georgia
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Atlanta, Georgia, Forenede Stater, 30331
- Local Institution - 0005
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Decatur, Georgia, Forenede Stater, 30030
- Local Institution - 0003
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New Jersey
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Marlton, New Jersey, Forenede Stater, 08053-3449
- Local Institution - 0001
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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
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Har en primær diagnose af skizofreni etableret ved en omfattende psykiatrisk evaluering baseret på DSM-5 (American Psychiatric Association 2013) kriterierne og bekræftet af Mini International Neuropsychiatric Interview (MINI) for Skizophrenia and Psychotic Disorder Studies version 7.0.2.
- Positiv og negativ syndromskala (PANSS) totalscore på ≤ 80 ved screening og baseline.
- Clinical Global Impression-Severity (CGI-S) score på ≤ 4 ved screening og baseline.
- Villig og i stand til at seponere al antipsykotisk medicin før baseline besøg.
Ekskluderingskriterier:
- Anamnese eller tilstedeværelse af klinisk signifikant kardiovaskulær, pulmonal, renal, hæmatologisk, gastrointestinal (GI), endokrin, immunologisk, dermatologisk, neurologisk eller onkologisk sygdom eller enhver anden tilstand, der efter investigatorens mening ville bringe deltagerens sikkerhed i fare eller validiteten af undersøgelsesresultaterne.
- Enhver primær DSM-5 lidelse bortset fra skizofreni inden for 12 måneder før screening.
- Historie om behandlingsresistens over for skizofrenimedicin.
- Anamnese med allergi/overfølsomhed over for KarXT.
- Andre protokol-definerede inklusion/eksklusionskriterier gælder.
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: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: KarXT på tom mave og sammen med mad
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Specificeret dosis på specificerede dage
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants With TEAEs From First Dose to End of Study Follow up.
Tidsramme: From first dose to end of study follow up (63 days)
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Number of participants with Treatment Emergent Adverse Events (TEAEs) from first dose to end of study follow up. An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention. |
From first dose to end of study follow up (63 days)
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Number of Participants With TEAEs at the End of Period 1 and Period 2.
Tidsramme: Period 1 (From first dose to day 28) Period 2 (day 29 to day 56)
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Number of participants with TEAEs at the end of period 1 and period 2. An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention. |
Period 1 (From first dose to day 28) Period 2 (day 29 to day 56)
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Number of Participants With Serious TEAEs at the End of Period 1 and Period 2.
Tidsramme: Period 1 (From first dose to day 28); Period 2 (day 29 to day 56); Overall (63 days)
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Number of participants with TEAEs at the end of period 1 and period 2. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization. |
Period 1 (From first dose to day 28); Period 2 (day 29 to day 56); Overall (63 days)
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Number of Participants With TEAEs Leading to Treatment Discontinuation.
Tidsramme: Period 1 (From first dose to day 28); Period 2 (day 29 to day 56); Overall (63 days)
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Number of participants with TEAEs leading to treatment discontinuation.
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Period 1 (From first dose to day 28); Period 2 (day 29 to day 56); Overall (63 days)
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Number of Participants With Pro-cholinergic and Anticholinergic TEAEs.
Tidsramme: Period 1 (From first dose to day 28); Period 2 (day 29 to day 56); Overall (63 days)
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The number of participants experiencing adverse events related to procholinergic symptoms (believed to be associated with xanomeline) and anticholinergic symptoms (believed to be associated with trospium) symptoms.
Examples of procholinergic symptoms include vomiting, nausea, diarrhea, sweating and hyper-salivation.
Examples of anticholinergic include dizziness, confusion, hallucinations, and somnolence.
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Period 1 (From first dose to day 28); Period 2 (day 29 to day 56); Overall (63 days)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change From Baseline in PANSS Total Score, Positive Score and Negative Score
Tidsramme: From first dose to end of treatment (56 days)
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The Positive and Negative Syndrome Scale (PANSS) assesses schizophrenia symptom severity using 30 items: 7 positive, 7 negative, and 16 general psychopathology scales.
Each item is rated from 1 (absent) to 7 (extreme).
Positive symptoms represent excesses or distortions of normal function (e.g., hallucinations, delusions), while negative symptoms reflect diminished function.
The PANSS positive and negative scores each sum their respective 7 items, ranging from 7 to 49, with higher scores indicating greater severity.
The PANSS Total Score sums all 30 items, ranging from 30 to 210, with higher scores reflecting worse overall symptom severity.
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From first dose to end of treatment (56 days)
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Change From Baseline in Marder Factor Score.
Tidsramme: From first dose to end of treatment (56 days)
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PANSS Marder factor score is the sum of 5 negative scales and 2 general scales (N1.
Blunted affect; N2.
Emotional withdrawal; N3.
Poor rapport; N4.
Passive/apathetic social withdrawal; N6.
Lack of spontaneity; G7.
Motor retardation; and G16.
Active social avoidance).
Participants are rated from 1 to 7 on each symptom scale, with a total score ranging from 7 to 49.
Higher score indicates more severe symptoms.
The negative symptoms in schizophrenia are the diminution or loss of normal functions.
Baseline is defined as the PANSS score at screening.
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From first dose to end of treatment (56 days)
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Change From Baseline in CGI Severity Score
Tidsramme: From first dose to end of treatment (56 days)
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Completed independently by a clinician, the CGI-S categorizes the severity of the illness as: 1 = Normal, not at all ill; 2 = Borderline mentally ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; and 7 = Among the most extremely ill patients, by asking the clinical 1 question and providing a rating based upon observed and reported symptoms, behavior, and function in the past 7 days to reflect the average severity level across the 7 days.
Higher score indicates more severe illness.
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From first dose to end of treatment (56 days)
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Number of Participants With Spontaneously Reported AESIs
Tidsramme: From first dose to end of study follow up (63 days)
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The AEs of special interest (AESIs) will be monitored and include symptomatic orthostasis, syncope(a transient loss of consciousness or fainting),and liver function test elevations as defined below.
For SAE reporting requirements for events of liver injury.
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From first dose to end of study follow up (63 days)
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Number of Participants With Clinically Significant Changes in Vital Signs
Tidsramme: From first dose to end of study follow up (63 days)
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Number of participants with clinically significant changes in vital signs
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From first dose to end of study follow up (63 days)
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Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments
Tidsramme: From first dose to end of study follow up (63 days)
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Number of participants with clinically significant changes in clinical laboratory assessments
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From first dose to end of study follow up (63 days)
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Number of Participants With Clinically Significant Changes in 12-lead ECGs
Tidsramme: From first dose to end of study follow up (63 days)
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Number of participants with clinically significant changes in 12-lead ECGs
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From first dose to end of study follow up (63 days)
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Number of Participants Who Exhibited Suicidal Behavior as Assessed by C-SSRS
Tidsramme: From first dose to end of study follow up (63 days)
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Number of participants who exhibited suicidal behavior as assessed by C-SSRS
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From first dose to end of study follow up (63 days)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studieleder: Bristol-Myers Squibb, Bristol-Myers Squibb
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
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)
28. oktober 2024
Primær færdiggørelse (Faktiske)
13. marts 2025
Studieafslutning (Faktiske)
13. marts 2025
Datoer for studieregistrering
Først indsendt
8. august 2024
Først indsendt, der opfyldte QC-kriterier
22. august 2024
Først opslået (Faktiske)
27. august 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CN012-0048
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
BMS vil give adgang til individuelle anonymiserede deltagerdata efter anmodning fra kvalificerede forskere og underlagt visse kriterier.
Yderligere oplysninger om Bristol Myer Squibbs datadelingspolitik og -proces kan findes på:
https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
IPD-delingstidsramme
Se Planbeskrivelse
IPD-delingsadgangskriterier
Se Planbeskrivelse
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .