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A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation

9. september 2026 oppdatert av: Otsuka Pharmaceutical Development & Commercialization, Inc.

A Phase 3b, Multicenter, Open-label, Single-arm Trial to Evaluate the Efficacy and Safety of Orally Administered Centanafadine QD XR Capsules in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation

The primary purpose of this study is to evaluate the efficacy of centanafadine once daily (QD) extended-release (XR) capsules in adults with attention-deficit/hyperactivity disorder (ADHD) and emotional dysregulation (ED).

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

80

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiekontakt

Studiesteder

  • Forente stater
    • Florida
      • Gainesville, Florida, Forente stater, 32607
      • Jacksonville, Florida, Forente stater, 32256
        • Har ikke rekruttert ennå
        • CNS Healthcare - Jacksonville (Clinical Neuroscience Solutions - Jacksonville)
        • Hovedetterforsker:
          • Jones
        • Ta kontakt med:
      • Maitland, Florida, Forente stater, 32751
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70125
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02132
      • Watertown, Massachusetts, Forente stater, 02472
    • Missouri
      • Saint Charles, Missouri, Forente stater, 63304
        • Har ikke rekruttert ennå
        • St. Charles Psychiatric Associates/Midwest Research Group
        • Ta kontakt med:
        • Hovedetterforsker:
          • Mattingly
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89128
        • Har ikke rekruttert ennå
        • Center for Psychiatry and Behavioral Medicine. Inc.
        • Ta kontakt med:
        • Hovedetterforsker:
          • Childress
    • New Jersey
      • Cherry Hill, New Jersey, Forente stater, 08002
    • New York
      • New York, New York, Forente stater, 10128
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45215
    • Oregon
      • Portland, Oregon, Forente stater, 97210
    • Texas
      • Austin, Texas, Forente stater, 78737
      • Bellaire, Texas, Forente stater, 77401
      • Houston, Texas, Forente stater, 77089
    • Washington
      • Everett, Washington, Forente stater, 98201

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

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria

  1. Primary diagnosis of ADHD per the Adult ADHD Clinical Diagnostic Scale (ACDS).
  2. Adult ADHD Investigator Symptom Rating Scale (AISRS) total score of ≥ 28 at baseline.
  3. Symptoms of ED as determined by the WRAADDS-ED subscale score ≥ 7 at baseline.
  4. CGI-S-ADHD rating ≥ 4 (at least moderate severity) at baseline.

Exclusion Criteria

  1. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a lifetime diagnosis of bipolar and related disorders, schizophrenia spectrum and other psychotic disorders, borderline and antisocial personality disorders, neurocognitive disorders, autism spectrum disorder, or intellectual disability.
  2. DSM-5 criteria for a current diagnosis of major depressive disorder, post-traumatic stress disorder, any substance use disorder, untreated/unstable obstructive sleep apnea, eating disorders, or obsessive compulsive disorder.
  3. Any other current DSM-5 comorbid psychiatric disorder identified by the Mini International Neuropsychiatric Interview (MINI) or any medical condition that, in the judgment of the investigator, could be expected to require treatment with medications prohibited in this trial that cannot be safely discontinued with completion of an appropriate washout, could confound efficacy or safety assessments, or be the primary driver of ED.
  4. Presence of an unstable or uncontrolled medical condition that, in the opinion of the investigator, could pose a safety risk to the participant or could manifest with psychiatric symptoms (eg, thyroid disease).
  5. In the clinical opinion of the investigator, the participant has not derived significant therapeutic benefit from 2 or more ADHD therapies of 2 different classes (eg, amphetamine and methylphenidate, or amphetamine and atomoxetine) given with an acceptable dose and duration during adulthood (aged 18 years or older).
  6. Current use of prohibited psychotropic medications that cannot be discontinued within 7 to 28 days prior to enrollment.
  7. Any disorder that is the primary focus of treatment other than ADHD.
  8. Evidence of current substance use disorder or history in the past 12 months.
  9. History of any prior exposure to centanafadine.
  10. Participated in other clinical trials involving investigational drugs within 180 days prior to screening or participated in more than 2 interventional clinical trials involving investigational drugs within the past year.
  11. Have an allergy to the IMP or any component of the IMP.

Note: Other protocol-specified inclusion/exclusion criteria may apply.

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: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Centanafadine XR
Participants will receive centanafadine XR capsule 328.8 milligrams (mg), orally, QD, for 8 weeks.
Legemiddel: Centanafadine XR
Oral capsules
Andre navn:
  • EB-1020

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Change From Baseline to Week 8 in the Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) Total Score
Tidsramme: Baseline up to Week 8
Baseline up to Week 8

Sekundære resultatmål

Resultatmål
Tidsramme
Change From Baseline to Week 8 in the Wender-Reimherr Adult Attention Deficit Disorder Scale Emotional Dysregulation (WRAADDS-ED) Subscale Score
Tidsramme: Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the Clinical Global Impressions-Severity Scale for Attention-Deficit/Hyperactivity Disorder (CGI-S-ADHD) Score
Tidsramme: Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) T-score for the Global Executive Composite (GEC) Scale
Tidsramme: Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the BRIEF-A T-score for the Behavioral Regulation Index (BRI) Scale
Tidsramme: Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the BRIEF-A T-score for the Metacognition Index (MI) Scale
Tidsramme: Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the Difficulties in Emotion Regulation Scale (DERS) Total Score
Tidsramme: Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the Nonacceptance of Emotional Responses (NONACCEPT) DERS Subscale Score
Tidsramme: Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the Difficulties Engaging in Goal-Directed Behavior (GOALS) DERS Subscale Score
Tidsramme: Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the Impulse Control Difficulties (IMPULSE) DERS Subscale Score
Tidsramme: Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the Lack of Emotional Awareness (AWARE) DERS Subscale Score
Tidsramme: Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the Limited Access to Emotion Regulation Strategies (STRATEGIES) DERS Subscale Score
Tidsramme: Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the Lack of Emotional Clarity (CLARITY) DERS Subscale Score
Tidsramme: Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the Attention-Deficit/Hyperactivity Disorder Symptoms, Executive Function Deficits, and Emotional Dyscontrol as Assessed by the Adult ADHD Self-Report Scale (ASRS) Score
Tidsramme: Baseline up to Week 8
Baseline up to Week 8
Number of Participants With Adverse Events
Tidsramme: Up to Week 9
Up to Week 9
Number of Participants With Suicidal Ideation or Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Tidsramme: Up to Week 9
Up to Week 9

Samarbeidspartnere og etterforskere

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

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

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)

1. september 2026

Primær fullføring (Antatt)

27. mai 2027

Studiet fullført (Antatt)

27. mai 2027

Datoer for studieregistrering

Først innsendt

6. august 2026

Først innsendt som oppfylte QC-kriteriene

6. august 2026

Først lagt ut (Faktiske)

12. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 405-201-00231

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

IPD-delingstidsramme

Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.

Tilgangskriterier for IPD-deling

Otsuka will share data on the Vivli data sharing platform: https://vivli.org/ourmember/Otsuka/

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF

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