En studie av effektiviteten og sikkerheten til SEP-363856 hos akutt psykotiske deltakere med schizofreni
En fase 3, randomisert, dobbeltblind, parallellgruppe, placebokontrollert, multisenter-studie for å evaluere effektiviteten og sikkerheten til SEP-363856 i akutt psykotiske deltakere med schizofreni
Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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Arkansas
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Bentonville, Arkansas, Forente stater, 72712
- Pillar Clinical Research LLC - Bentonville Site
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Little Rock, Arkansas, Forente stater, 72204
- Pillar Clinical Research (Little Rock AR) Site
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Little Rock, Arkansas, Forente stater, 72211
- Woodland International Research Group Site
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Rogers, Arkansas, Forente stater, 72758
- Woodland Research Northwest Site
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California
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Bellflower, California, Forente stater, 90706
- Clinical Innovations, Inc. dba CITrials (Bellflower)
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Culver City, California, Forente stater, 90230
- ProScience Research Group Site
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Garden Grove, California, Forente stater, 92845
- CenExel CNS - Garden Grove (Collaborative Neuroscience Research) Site
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Lemon Grove, California, Forente stater, 91945
- Synergy San Diego Site
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Montclair, California, Forente stater, 91763
- Catalina Research Institute Site
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Riverside, California, Forente stater, 92506
- Clinical Innovations Inc. DBA CITrials (Riverside)
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Riverside, California, Forente stater, 92506
- Richmond Behavioral Associates LLC
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San Diego, California, Forente stater, 92123
- CNRI - San Diego LLC Site
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Sherman Oaks, California, Forente stater, 91403
- Schuster Medical Research Institute
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Torrance, California, Forente stater, 90504
- CenExel CNS - Los Alamitos (Collaborative Neuroscience Research)
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Florida
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Hialeah, Florida, Forente stater, 33016
- Galiz Research Site
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Hollywood, Florida, Forente stater, 33021
- Segal Trials - Larkin Behavioral Health - Inpatient & Early Phase Site
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Hollywood, Florida, Forente stater, 33024
- Cenexel RCA (Research Centers of America) Site
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Miami, Florida, Forente stater, 33122
- Premier Clinical Research Institute
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Miami, Florida, Forente stater, 33155
- D & H National Research Centers NC
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Miami Lakes, Florida, Forente stater, 33016
- Innovative Clinical Research, Inc. Site
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West Palm Beach, Florida, Forente stater, 33407
- Health Synergy Clinical Research LLC Site
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Georgia
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Atlanta, Georgia, Forente stater, 30328
- Synexus Clinical Research US Inc - Atlanta
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Atlanta, Georgia, Forente stater, 30331
- CenExel ACMR (Atlanta Center for Medical Research, LLC) Site
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Decatur, Georgia, Forente stater, 30030
- CenExel IRA (CenExcel iResearch, LLC) Site
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Peachtree Corners, Georgia, Forente stater, 30071
- Accelerated Clinical Trials in Peachtree Corners GA Site
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Illinois
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Chicago, Illinois, Forente stater, 60640
- Uptown Research Institute
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Chicago, Illinois, Forente stater, 60641
- Pillar Clinical Research LLC (Chicago)
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Louisiana
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New Orleans, Louisiana, Forente stater, 70127
- Eastern Clinical Research Associates
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Maryland
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Gaithersburg, Maryland, Forente stater, 20877
- Cenexel CBH (CBH Health)
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New Jersey
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Marlton, New Jersey, Forente stater, 20877
- Hassman Research Institute, LLC
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Ohio
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North Canton, Ohio, Forente stater, 44720
- Neuro-Behavioral Clinical Research Site
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Texas
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Austin, Texas, Forente stater, 78754
- Community Clinical Research Inc
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DeSoto, Texas, Forente stater, 75115
- InSite Clinical Research
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Houston, Texas, Forente stater, 77043
- HD Research - Memorial Hermann Surgery Center Memorial Village
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Richardson, Texas, Forente stater, 75080
- Pillar Clinical Research LLC (Richardson, TX) Site
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Wakayama, Japan, 641-8510
- Wakayama Medical University Hospital
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Aichi-ken
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Konan-shi, Aichi-ken, Japan, 483-8248
- Hotei Hospital
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Toyoake-shi, Aichi-ken, Japan, 470-1168
- Seishinkai Okehazama Hospital
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Aomori
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Hachinohe-shi, Aomori, Japan, 039-1104
- Seijinkai Seinan Hospital
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Chiba
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Chiba, Chiba, Japan, 266-0007
- National Hospital Organization Shimofusa Psychiatric Medical Center
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Ichikawa-shi, Chiba, Japan, 272-8516
- National Kohnodai Medical Center
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Fukuoka
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Fukuoka, Fukuoka, Japan, 814-0180
- Fukuoka University Hospital
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Fukuoka, Fukuoka, Japan, 819-0037
- Kuramitsu Hospital
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Kokuraminami-ku, Kitakyushu-shi, Fukuoka, Japan, 802-8533
- National Hospital Organization Kokura Medical Center Site
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Omuta-shi, Fukuoka, Japan, 836-0004
- Shiranui Hospital
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Fukushima
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Kōriyama, Fukushima, Japan, 963-0198
- Social Medical Corporation Asaka Hospital
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Hiroshima
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Kure, Hiroshima, Japan, 737-0111
- Hayakawa Clinic
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Kure-shi, Hiroshima, Japan, 737-0023
- NHO Kure Medical Center
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Hokkaido
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Nayoro-shi, Hokkaido, Japan, 096-8511
- Nayoro City General Hospital
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Obihiro, Hokkaido, Japan, 080-0024
- Obihiro Kosei Hospital
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Sapporo, Hokkaido, Japan, 002-8029
- Goryokai Medical Corporation Hospital
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Iwate
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Shiwa-gun, Iwate, Japan, 028-3695
- Iwate Medical University Hospital
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Kanagawa
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Hadano-shi, Kanagawa, Japan, 257-0003
- Hatano Kousei Hospital
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Hadano-shi, Kanagawa, Japan, 259-1304
- Tanzawa Hospital
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Hiratsuka-shi, Kanagawa, Japan, 259-1205
- Fujimidai Hospital Site
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Yokohama, Kanagawa, Japan, 234-0051
- Yokohama Hino Hospital
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Kumamoto
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Kumamoto, Kumamoto, Japan, 861-8002
- Yuge Hospital
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Miyazaki
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Miyakonojo-shi, Miyazaki, Japan, 885-0093
- Miyakonojo Shinsei Hospital
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Osaka
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Moriguchi-shi, Osaka, Japan, 570-8507
- Kansai Medical University Medical Center
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Neyagawa, Osaka, Japan, 572-0854
- Neyagawa Sanatorium
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Saga-ken
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Kanzaki-gun, Saga-ken, Japan, 842-0192
- National Hospital Organization Hizen Psychiatric Medical Center Site
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Karatsu-shi, Saga-ken, Japan, 847-0031
- Rainbow and Sea Hospital
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Tosu-shi, Saga-ken, Japan, 841-0081
- Inuo Hospital
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Shiga
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Ōtsu, Shiga, Japan, 520-2192
- Shiga University of Medical Science Hospital
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Tochigi
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Shimotsuga-gun, Tochigi, Japan, 321-0293
- Dokkyo Medical University Hospital
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Shimotsuke-Shi, Tochigi, Japan, 329-0498
- Jichi Medical University Hospital
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Utsunomiya, Tochigi, Japan, 329-1104
- Tochigi Prefectural Okamotodai Hospital
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Tokyo
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Kodaira-shi, Tokyo, Japan, 187-8551
- National Center of Neurology and Psychiatry
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Machida-shi, Tokyo, Japan, 194-0005
- Asuka Hospital
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Setagaya-ku, Tokyo, Japan, 157-8577
- Showa Medical University Karasuyama Hospital
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Toyama
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Toyama, Toyama, Japan, 930-8550
- Toyama Prefectural Center Hospital
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Yamagata
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Sakata-shi, Yamagata, Japan, 998-0074
- Sanyo Hospital
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Yamagata, Yamagata, Japan, 990-0045
- Yamagata Sakuracho Hospital Site
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Key Inclusion Criteria:
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Male or female participants between 18 to 65 years of age (inclusive) at the time of consent.
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Participant has an identified reliable informant (eg, caregiver, relative, friend, case worker, residential treatment staff).
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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.
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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:
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Participant must have a PANSS total score ≥ 80
AND
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Participant must have a CGI-S score ≥ 4.
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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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: Placebo
Placebo |
tablet |
|
Eksperimentell: SEP-363856 75 mg
SEP-363856 75 mg/day |
tablet |
|
Eksperimentell: SEP-363856 100 mg
SEP-363856 100 mg/day |
tablet |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 382-201-00035
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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.
Tilgangskriterier for IPD-deling
Otsuka will share data on the Vivli data sharing platform which can be found here: http://vivli.org/ourmember/Otsuka/
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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