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Effekt- og sikkerhedsundersøgelse af adjunktiv troriluzule ved obsessiv-kompulsiv lidelse

29. april 2026 opdateret af: Biohaven Pharmaceuticals, Inc.

Et randomiseret, dobbeltblindt, placebokontrolleret forsøg med adjunktiv troriluzol ved obsessiv-kompulsiv lidelse

Undersøgelsens formål er at evaluere effektiviteten og sikkerheden af ​​troriluzol som supplerende terapi sammenlignet med placebo hos personer med obsessiv-kompulsiv lidelse (OCD)

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

589

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary
    • Ontario
      • Chatham, Ontario, Canada, N7L 1C1
        • Chatham-Kent Clinical Trials Research Centre
      • Hamilton, Ontario, Canada, L8S 1B7
        • McMaster University, Hamilton Health Sciences
      • Kingston, Ontario, Canada, K7L 5G2
        • Queen's University
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada, M4W 2N4
        • START Clinic for Mood and Anxiety Disorders
      • Toronto, Ontario, Canada, M6J 1H4
        • University of Toronto / Centre for Addiction and Mental Health (CAMH)
  • Det Forenede Kongerige
      • Blackpool, Det Forenede Kongerige, FY2 0JH
        • MAC Clinical Research-Lancashire
      • Leeds, Det Forenede Kongerige, LS10 1DU
        • MAC Clinical Research
      • Liverpool, Det Forenede Kongerige, L34 1BH
        • MAC Clinical Research -- Merseyside
      • Manchester, Det Forenede Kongerige, M25 3BL
        • Greater Manchester Mental Health NHS Foundation Trust
      • Milton Keynes, Det Forenede Kongerige, MK15 0DU
        • Bioluminux Ltd
      • Swindon, Det Forenede Kongerige, SN3 6BW
        • Kingshill Research Centre
      • Tankersley, Det Forenede Kongerige, S75 3DL
        • MAC Clinical Research-- South Yorkshire
    • County Durham
      • Stockton-on-Tees, County Durham, Det Forenede Kongerige, TS17 6EW
        • MAC Clinical Research
    • Northamptonshire
      • Stony Stratford, Northamptonshire, Det Forenede Kongerige, MK19 6FG
        • Stemax Consult - Healthcare Services Ltd
    • South Staffordshire
      • Cannock, South Staffordshire, Det Forenede Kongerige, WS11 0BN
        • MAC Clinical Research - South Staffordshire
  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85012
        • Alea Research
    • California
      • Culver City, California, Forenede Stater, 90230
        • ProScience Research Group
      • La Jolla, California, Forenede Stater, 92037
        • Kaizen Brain Center
      • Lancaster, California, Forenede Stater, 93534
        • Om Research LLC
      • Los Angeles, California, Forenede Stater, 90024
        • CalNeuro Research Group
      • San Jose, California, Forenede Stater, 95124
        • Lumos Clinical Research Center, LLC
      • Santa Ana, California, Forenede Stater, 92704
        • Velocity Clinical Research
      • Sherman Oaks, California, Forenede Stater, 91403
        • California Neuroscience Research Medical Group, Inc.
      • Upland, California, Forenede Stater, 91786
        • Pacific Clinical Research Medical Group
    • Colorado
      • Denver, Colorado, Forenede Stater, 80209
        • Mountain View Clinical Research
    • Connecticut
      • Norwich, Connecticut, Forenede Stater, 06360
        • Comprehensive Psychiatric Care
    • Florida
      • Apopka, Florida, Forenede Stater, 32703
        • Topaz Clinical Research
      • Coral Springs, Florida, Forenede Stater, 33067
        • CNS Research of Coral Springs
      • Fort Myers, Florida, Forenede Stater, 33912
        • Gulfcoast Clinical Research Center
      • Gainesville, Florida, Forenede Stater, 32606
        • University of Florida Department of Psychiatry
      • Jacksonville, Florida, Forenede Stater, 32256
        • Clinical Neuroscience Solutions, Inc.
      • Miami, Florida, Forenede Stater, 33165
        • Med-Care Research
      • Miami, Florida, Forenede Stater, 33175
        • Ezy Medical Research, Co.
      • Naples, Florida, Forenede Stater, 34102
        • Advanced Research for Health Improvement
      • North Miami Beach, Florida, Forenede Stater, 33162
        • Harmony Clinical Research
      • Palm Beach, Florida, Forenede Stater, 33480
        • DTMS Center LLC
      • Pinellas Park, Florida, Forenede Stater, 33782
        • DMI Research
    • Georgia
      • Decatur, Georgia, Forenede Stater, 30030
        • CenExel iResearch
      • Snellville, Georgia, Forenede Stater, 30078
        • Renew Health Clinical Research, LLC
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • University of Chicago Department of Psychiatry & Behavioral Neuroscience
      • Naperville, Illinois, Forenede Stater, 60563
        • AMR-Baber Research, Inc.
    • Kansas
      • Overland Park, Kansas, Forenede Stater, 66210
        • Collective Medical Research
    • Maryland
      • Towson, Maryland, Forenede Stater, 21204
        • Continental Clinical Solutions, LLC
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02131
        • Boston Clinical Trials
    • Missouri
      • O'Fallon, Missouri, Forenede Stater, 63368
        • Psychiatric Care and Research Center
    • Montana
      • Missoula, Montana, Forenede Stater, 59804
        • Boeson Research
    • New Jersey
      • Cherry Hill, New Jersey, Forenede Stater, 08028
        • Center For Emotional Fitness
    • New York
      • Brooklyn, New York, Forenede Stater, 11235
        • SPRI Clinical Trials, LLC
      • New York, New York, Forenede Stater, 10036
        • Manhattan Behavioral Medicine, PLLC
    • North Carolina
      • Raleigh, North Carolina, Forenede Stater, 27609
        • Richard H. Weisler, MD PA & Associates
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45212
        • CTI Clinical Research Center
      • Dayton, Ohio, Forenede Stater, 45432
        • American Clinical Research Institute (ACRI)
      • Kettering, Ohio, Forenede Stater, 45439
        • American Research Institute (ACRI)
      • Middleburg Heights, Ohio, Forenede Stater, 44130
        • North Star Medical Research, LLC
    • Pennsylvania
      • Allentown, Pennsylvania, Forenede Stater, 18104
        • Lehigh Center for Clinical Research
      • Media, Pennsylvania, Forenede Stater, 19063
        • Suburban Research Associates
    • Texas
      • Austin, Texas, Forenede Stater, 78737
        • Donald J. Garcia Jr., MD PA
      • Baytown, Texas, Forenede Stater, 77521
        • Inquest Clinical Research
      • Dallas, Texas, Forenede Stater, 75231
        • FutureSearch Trials of Dallas, LP
      • DeSoto, Texas, Forenede Stater, 75115
        • InSite Clinical Research
      • Houston, Texas, Forenede Stater, 77074
        • Clinical Trial Network
      • Plano, Texas, Forenede Stater, 75093
        • AIM Trials
      • San Antonio, Texas, Forenede Stater, 78229
        • Clinical Trials of Texas, Inc.
    • Vermont
      • Woodstock, Vermont, Forenede Stater, 05091
        • Woodstock Research Center
  • Holland
      • Amsterdam, Holland, 1100
        • Amsterdam UMC, locatie AMC
      • Leiden, Holland, 2333
        • Leiden University Medical Center (LUMC)
  • Italien
      • Milan, Italien, 20157
        • ASST FBF SACCO - Ospedale Universitario Luigi Sacco
      • Naples, Italien, 80131
        • University School of Medicine of Napoli Federico II
      • Pisa, Italien, 56126
        • University of Pisa
      • Turin, Italien, 10043
        • University of Turin - university hospital san luigi gonzaga
  • Kina
    • Changping District
      • Beijing, Changping District, Kina, 100085
        • Beijing HuiLongGuan Hospital
    • Haidian District
      • Beijing, Haidian District, Kina, 100083
        • Peking University Sixth Hospital
    • Hangzhou City
      • Hangzhou, Hangzhou City, Kina, 310063
        • Hangzhou Seventh People's Hospital
    • Hexi District
      • Tianjin, Hexi District, Kina, 300222
        • Tianjin Anding Hospital
    • Hunan
      • Xiangya, Hunan, Kina, 410008
        • The Second Xiangya Hospital of Central South University
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210029
        • Nanjing Brain Hospital
    • Minhang District
      • Shanghai, Minhang District, Kina, 201108
        • Shanghai Mental Health Center
    • Qiaokou District
      • Wuhan, Qiaokou District, Kina, 430022
        • Wuhan Mental Health Center
    • Tianhe District
      • Guangzhou, Tianhe District, Kina, 510660
        • The First Affiliated Hospital of Jinan University
    • Wuhou District
      • Chengdu, Wuhou District, Kina, 610041
        • Mental Health Center, West China Hospital, Sichuan University
    • Yuhua District
      • Shijiazhuang, Yuhua District, Kina, 050001
        • First Hospital of Hebei Medical University
  • Spanien
      • Barcelona, Spanien, 08907
        • Hospital Universitario de Bellvitge
      • Madrid, Spanien, 28034
        • Hospital Universitario Ramón y Cajal
      • Madrid, Spanien, 28040
        • Hospital Clinico San Carlos
      • Oviedo, Spanien, 33011
        • Centro de Salud Mental La Corredoria
      • Salamanca, Spanien, 37005
        • Centro de Salud San Juan
      • Vigo, Spanien, 36312
        • Hospital Álvaro Cunqueiro

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

Nøgleinklusionskriterier:

  1. Primær diagnose af obsessiv-kompulsiv lidelse (OCD) i henhold til Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition som bekræftet af MINI ved screening; varigheden af ​​forsøgspersonens sygdom skal være ≥ 1 år
  2. En utilstrækkelig respons på nuværende Standard of Care-medicin defineret som selektiv serotonin-genoptagelseshæmmer (undtagen fluvoxamin) eller clomipramin-behandling ved en passende og stabil dosis i mindst 8 uger før screening og mindst 12 uger ved baseline (tilstrækkelig dosis defineret af USPI-mærkning) ); en utilstrækkelig respons for nuværende standard for bilbase på YBOCS-score.
  3. Bestemt af investigator til at være medicinsk stabil ved baseline/randomisering vurderet ved sygehistorie, fysisk undersøgelse, laboratorietestresultater og elektrokardiogramtest. Forsøgspersoner skal være fysisk i stand til og forventes at gennemføre sporet som designet.

Nøgleekskluderingskriterier:

  1. Individer med en historie på mere end to (2) tidligere mislykkede eller utilstrækkelige behandlingsklasser givet i en passende varighed ved en passende dosis som defineret af MGH-TRQ-OCD.
  2. Aktuel eller tidligere historie med: bipolar I eller II lidelse, skizofreni eller andre psykotiske lidelser, skizoaffektiv lidelse, autisme eller autismespektrumforstyrrelser, borderline personlighedsforstyrrelse, antisocial personlighedsforstyrrelse, Tourettes lidelse, kropsdysmorfisk lidelse, hamstringsforstyrrelse eller psykokirurgi, Deep Brain Stimulering (DBS) eller elektrokonvulsiv terapi (ECT); eller generel medicinsk tilstand, der kan forvirre sikkerheds- og/eller effektivitetsresultater.
  3. Tidligere behandling i et studie med troriluzole

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: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Troriluzole
Participants received troriluzole 200 milligrams (mg) (100 mg*2) capsules orally once daily for the first two weeks and up-titrated to 280 mg (140 mg*2) capsules orally once daily for the next eight weeks, in the double-blind randomization phase.
Medicin: Troriluzole
Capsules for oral administration.
Placebo komparator: Placebo
Participants received placebo-matched to troriluzole capsules orally once daily for 10 weeks of the double-blind randomization phase.
Medicin: Placebo
Drug- matching capsules for oral administration.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in the Y-BOCS Total Score in the Baseline Y-BOCS ≥24 Stratification Cohort at Week 8 (Negative Change Indicates Symptom Improvement)
Tidsramme: Baseline and Week 8
Y-BOCS was a clinician-administered instrument used to assess the severity of obsessive compulsive disorder (OCD) symptoms and to monitor treatment response. The scale included 10 items: 5 items assessed obsessions and 5 items assessed compulsions. Each item was rated from 0 to 4, generating an obsessions subscale score (0-20), a compulsions subscale score (0-20), and a total score ranging from 0 to 40. Higher scores indicated greater OCD symptom severity. Negative change (or reduction in score) indicates improvement.
Baseline and Week 8

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Tidsramme: From first dose up to approximately 12 weeks
An Adverse event (AE) was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant, that did not necessarily have a causal relationship with treatment. An AE could be any unfavourable/unintended sign including an abnormal laboratory finding, symptom/disease temporally associated with the use of the study drug, whether or not considered related to it. A TEAE was defined as any AE that developed, worsened, or became serious after first dose of test treatment
From first dose up to approximately 12 weeks
Change From Baseline in Sheehan Disability Scale (SDS) Total Score in the Baseline Y-BOCS ≥24 Stratification Cohort at Week 8
Tidsramme: Baseline and Week 8
The SDS was a participant-rated measure of functional disability. SDS was assessed in 3 domains: work/school (0-10), social life (0-10), and family life (0-10). The score from each domain was summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). Higher scores indicated a more severe impairment.
Baseline and Week 8
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Total Score in the Baseline Y-BOCS ≥24 Stratification Cohort at Week 8
Tidsramme: Baseline and Week 8
The CGI-S was a clinician rated assessment of the participants current illness state on a 7-point scale. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Higher scores indicated a more severe illness.
Baseline and Week 8

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in the Y-BOCS Total Score in the Baseline Y-BOCS = 22 or 23 Stratification Cohort at Week 8 (Negative Change Indicates Symptom Improvement)
Tidsramme: Baseline and Week 8
Y-BOCS was a clinician-administered instrument used to assess the severity of obsessive compulsive disorder (OCD) symptoms and to monitor treatment response. The scale included 10 items: 5 items assessed obsessions and 5 items assessed compulsions. Each item was rated from 0 to 4, generating an obsessions subscale score (0-20), a compulsions subscale score (0-20), and a total score ranging from 0 to 40. Higher scores indicated greater OCD symptom severity. Negative change (or reduction in score) indicates improvement.
Baseline and Week 8

Samarbejdspartnere og efterforskere

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

Sponsor

Biohaven Pharmaceuticals, Inc.

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)

29. januar 2021

Primær færdiggørelse (Faktiske)

29. april 2025

Studieafslutning (Faktiske)

29. april 2025

Datoer for studieregistrering

Først indsendt

30. december 2020

Først indsendt, der opfyldte QC-kriterier

30. december 2020

Først opslået (Faktiske)

5. januar 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BHV4157-303
  • 2024-514585-39-00 (Ctis)

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

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 .

Kliniske forsøg med Tvangslidelse

Kliniske forsøg med Troriluzole

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Bosnia & Herzegovina

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner