En prøve med effektiviteten og sikkerheden af SEP-363856 hos akut psykotiske deltagere med skizofreni
2. oktober 2026 opdateret af: Otsuka Pharmaceutical Development & Commercialization, Inc.
En fase 3, randomiseret, dobbeltblind, parallel-gruppe, placebokontrolleret, multicenterforsøg for at evaluere effektiviteten og sikkerheden af SEP-363856 hos akut psykotiske deltagere med skizofreni
Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants with Schizophrenia
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
538
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Arkansas
-
Bentonville, Arkansas, Forenede Stater, 72712
- Pillar Clinical Research LLC - Bentonville Site
-
Little Rock, Arkansas, Forenede Stater, 72204
- Pillar Clinical Research (Little Rock AR) Site
-
Little Rock, Arkansas, Forenede Stater, 72211
- Woodland International Research Group Site
-
Rogers, Arkansas, Forenede Stater, 72758
- Woodland Research Northwest Site
-
-
California
-
Bellflower, California, Forenede Stater, 90706
- Clinical Innovations, Inc. dba CITrials (Bellflower)
-
Culver City, California, Forenede Stater, 90230
- ProScience Research Group Site
-
Garden Grove, California, Forenede Stater, 92845
- CenExel CNS - Garden Grove (Collaborative Neuroscience Research) Site
-
Lemon Grove, California, Forenede Stater, 91945
- Synergy San Diego Site
-
Montclair, California, Forenede Stater, 91763
- Catalina Research Institute Site
-
Riverside, California, Forenede Stater, 92506
- Clinical Innovations Inc. DBA CITrials (Riverside)
-
Riverside, California, Forenede Stater, 92506
- Richmond Behavioral Associates LLC
-
San Diego, California, Forenede Stater, 92123
- CNRI - San Diego LLC Site
-
Sherman Oaks, California, Forenede Stater, 91403
- Schuster Medical Research Institute
-
Torrance, California, Forenede Stater, 90504
- CenExel CNS - Los Alamitos (Collaborative Neuroscience Research)
-
-
Florida
-
Hialeah, Florida, Forenede Stater, 33016
- Galiz Research Site
-
Hollywood, Florida, Forenede Stater, 33021
- Segal Trials - Larkin Behavioral Health - Inpatient & Early Phase Site
-
Hollywood, Florida, Forenede Stater, 33024
- Cenexel RCA (Research Centers of America) Site
-
Miami, Florida, Forenede Stater, 33122
- Premier Clinical Research Institute
-
Miami, Florida, Forenede Stater, 33155
- D & H National Research Centers NC
-
Miami Lakes, Florida, Forenede Stater, 33016
- Innovative Clinical Research, Inc. Site
-
West Palm Beach, Florida, Forenede Stater, 33407
- Health Synergy Clinical Research LLC Site
-
-
Georgia
-
Atlanta, Georgia, Forenede Stater, 30328
- Synexus Clinical Research US Inc - Atlanta
-
Atlanta, Georgia, Forenede Stater, 30331
- CenExel ACMR (Atlanta Center for Medical Research, LLC) Site
-
Decatur, Georgia, Forenede Stater, 30030
- CenExel IRA (CenExcel iResearch, LLC) Site
-
Peachtree Corners, Georgia, Forenede Stater, 30071
- Accelerated Clinical Trials in Peachtree Corners GA Site
-
-
Illinois
-
Chicago, Illinois, Forenede Stater, 60640
- Uptown Research Institute
-
Chicago, Illinois, Forenede Stater, 60641
- Pillar Clinical Research LLC (Chicago)
-
-
Louisiana
-
New Orleans, Louisiana, Forenede Stater, 70127
- Eastern Clinical Research Associates
-
-
Maryland
-
Gaithersburg, Maryland, Forenede Stater, 20877
- Cenexel CBH (CBH Health)
-
-
New Jersey
-
Marlton, New Jersey, Forenede Stater, 20877
- Hassman Research Institute, LLC
-
-
Ohio
-
North Canton, Ohio, Forenede Stater, 44720
- Neuro-Behavioral Clinical Research Site
-
-
Texas
-
Austin, Texas, Forenede Stater, 78754
- Community Clinical Research Inc
-
DeSoto, Texas, Forenede Stater, 75115
- InSite Clinical Research
-
Houston, Texas, Forenede Stater, 77043
- HD Research - Memorial Hermann Surgery Center Memorial Village
-
Richardson, Texas, Forenede Stater, 75080
- Pillar Clinical Research LLC (Richardson, TX) Site
-
-
-
-
-
Wakayama, Japan, 641-8510
- Wakayama Medical University Hospital
-
-
Aichi-ken
-
Konan-shi, Aichi-ken, Japan, 483-8248
- Hotei Hospital
-
Toyoake-shi, Aichi-ken, Japan, 470-1168
- Seishinkai Okehazama Hospital
-
-
Aomori
-
Hachinohe-shi, Aomori, Japan, 039-1104
- Seijinkai Seinan Hospital
-
-
Chiba
-
Chiba, Chiba, Japan, 266-0007
- National Hospital Organization Shimofusa Psychiatric Medical Center
-
Ichikawa-shi, Chiba, Japan, 272-8516
- National Kohnodai Medical Center
-
-
Fukuoka
-
Fukuoka, Fukuoka, Japan, 814-0180
- Fukuoka University Hospital
-
Fukuoka, Fukuoka, Japan, 819-0037
- Kuramitsu Hospital
-
Kokuraminami-ku, Kitakyushu-shi, Fukuoka, Japan, 802-8533
- National Hospital Organization Kokura Medical Center Site
-
Omuta-shi, Fukuoka, Japan, 836-0004
- Shiranui Hospital
-
-
Fukushima
-
Kōriyama, Fukushima, Japan, 963-0198
- Social Medical Corporation Asaka Hospital
-
-
Hiroshima
-
Kure, Hiroshima, Japan, 737-0111
- Hayakawa Clinic
-
Kure-shi, Hiroshima, Japan, 737-0023
- NHO Kure Medical Center
-
-
Hokkaido
-
Nayoro-shi, Hokkaido, Japan, 096-8511
- Nayoro City General Hospital
-
Obihiro, Hokkaido, Japan, 080-0024
- Obihiro Kosei Hospital
-
Sapporo, Hokkaido, Japan, 002-8029
- Goryokai Medical Corporation Hospital
-
-
Iwate
-
Shiwa-gun, Iwate, Japan, 028-3695
- Iwate Medical University Hospital
-
-
Kanagawa
-
Hadano-shi, Kanagawa, Japan, 257-0003
- Hatano Kousei Hospital
-
Hadano-shi, Kanagawa, Japan, 259-1304
- Tanzawa Hospital
-
Hiratsuka-shi, Kanagawa, Japan, 259-1205
- Fujimidai Hospital Site
-
Yokohama, Kanagawa, Japan, 234-0051
- Yokohama Hino Hospital
-
-
Kumamoto
-
Kumamoto, Kumamoto, Japan, 861-8002
- Yuge Hospital
-
-
Miyazaki
-
Miyakonojo-shi, Miyazaki, Japan, 885-0093
- Miyakonojo Shinsei Hospital
-
-
Osaka
-
Moriguchi-shi, Osaka, Japan, 570-8507
- Kansai Medical University Medical Center
-
Neyagawa, Osaka, Japan, 572-0854
- Neyagawa Sanatorium
-
-
Saga-ken
-
Kanzaki-gun, Saga-ken, Japan, 842-0192
- National Hospital Organization Hizen Psychiatric Medical Center Site
-
Karatsu-shi, Saga-ken, Japan, 847-0031
- Rainbow and Sea Hospital
-
Tosu-shi, Saga-ken, Japan, 841-0081
- Inuo Hospital
-
-
Shiga
-
Ōtsu, Shiga, Japan, 520-2192
- Shiga University of Medical Science Hospital
-
-
Tochigi
-
Shimotsuga-gun, Tochigi, Japan, 321-0293
- Dokkyo Medical University Hospital
-
Shimotsuke-Shi, Tochigi, Japan, 329-0498
- Jichi Medical University Hospital
-
Utsunomiya, Tochigi, Japan, 329-1104
- Tochigi Prefectural Okamotodai Hospital
-
-
Tokyo
-
Kodaira-shi, Tokyo, Japan, 187-8551
- National Center of Neurology and Psychiatry
-
Machida-shi, Tokyo, Japan, 194-0005
- Asuka Hospital
-
Setagaya-ku, Tokyo, Japan, 157-8577
- Showa Medical University Karasuyama Hospital
-
-
Toyama
-
Toyama, Toyama, Japan, 930-8550
- Toyama Prefectural Center Hospital
-
-
Yamagata
-
Sakata-shi, Yamagata, Japan, 998-0074
- Sanyo Hospital
-
Yamagata, Yamagata, Japan, 990-0045
- Yamagata Sakuracho Hospital Site
-
-
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
Køn, der er berettiget til at studere
Alle
Beskrivelse
Key Inclusion Criteria:
-
Male or female participants between 18 to 65 years of age (inclusive) at the time of consent.
-
Participant has an identified reliable informant (eg, caregiver, relative, friend, case worker, residential treatment staff).
-
Participant is experiencing an acute exacerbation or relapse of symptoms, with onset ≤ 2 months prior to screening
- The participant requires hospitalization for this acute exacerbation or relapse of symptoms.
- If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening.
-
Participants who are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by meeting ALL of the following criteria at the screening and baseline visits:
-
Participant must have a PANSS total score ≥ 80
AND
-
Participant must have a CGI-S score ≥ 4.
-
-
Participants who have received previous outpatient antipsychotic treatment at an adequate dose (minimal recommended dose for the treatment of schizophrenia according to the manufacturer labeling) for an adequate duration (at least 6 weeks) and who showed a previous good response.
Key Exclusion Criteria:
- Sexually active participants or persons of childbearing potential who do not agree to practice 2 different clinical trial sponsor approved methods of birth control or remain abstinent during the course of the trial and for 30 days after the last dose of study drug.
- Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia.
- Participant has had psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days prior to screening.
- Participant has previously received SEP-363856 or was previously enrolled in a SEP-363856 clinical study
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: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Placebo
Placebo |
tablet |
|
Eksperimentel: SEP-363856 75 mg
SEP-363856 75 mg/day |
tablet |
|
Eksperimentel: SEP-363856 100 mg
SEP-363856 100 mg/day |
tablet |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The change from baseline in Positive And Negative Syndrome Scale (PANSS) total score at Week 6
Tidsramme: Baseline to Week 6
|
To evaluate the efficacy of SEP-363856 (75 and 100 mg/day) compared with placebo in acutely psychotic participants with schizophrenia. PANSS total - 30-210 Higher score is indicative of greater symptomatology |
Baseline to Week 6
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical Global Impression-Severity (CGI-S)
Tidsramme: Baseline to Week 6
|
Change from baseline in CGI-S score at Week 6. CGI-S is 0-7 with higher score is indicative of greater symptomatology |
Baseline to Week 6
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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.
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. februar 2025
Primær færdiggørelse (Anslået)
20. oktober 2026
Studieafslutning (Anslået)
29. oktober 2026
Datoer for studieregistrering
Først indsendt
27. februar 2025
Først indsendt, der opfyldte QC-kriterier
24. marts 2025
Først opslået (Faktiske)
25. marts 2025
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. oktober 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. oktober 2026
Sidst verificeret
1. oktober 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 382-201-00035
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Anonymized Individual participant data (IPD) that underlie the result of this study will be shared with researchers to achieve aims pre-specified in a methodology 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.
IPD-delingsadgangskriterier
Otsuka will share data on the Vivli data sharing platform which can be found here: http://vivli.org/ourmember/Otsuka/
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 .