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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05359081
Other study ID # DA801202
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date May 16, 2022
Est. completion date March 28, 2024

Study information

Verified date April 2024
Source Sumitomo Pharma Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A clinical study to investigate the long-term safety and torelability of SEP-363856 in clinically stable adult patients with schizophrenia in Japan.


Description:

A phase 3, 52-week, open-label study to evaluate the long-term safety and tolerability of SEP-363856 in patients with schizophrenia in Japan. Participants will take flexible dose of SEP-363856 (50 mg/day and 75 mg/day) every night at bedtime for 52 weeks in an open-label manner.


Recruitment information / eligibility

Status Terminated
Enrollment 68
Est. completion date March 28, 2024
Est. primary completion date March 21, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. Must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities. 2. Male or female between 18 to 65 years of age (inclusive) at the time of consent. 3. Must meet DSM 5 criteria for schizophrenia as established by clinical interview at Screening 4. Must have a PANSS total score >=60 at Screening and Baseline. 5. Must have a CGI-S score >=3 at Screening and Baseline 6. Judged to be clinically stable (i.e., no evidence of an acute exacerbation) by the Investigator for at least 8 weeks prior to Baseline and has had no change in antipsychotic medication(s) (minor dose adjustments for tolerability purposes are permitted) for at least 6 weeks prior to Screening 7. In the opinion of the Investigator, subjects must be generally healthy based on Screening medical history, physical examination, vital signs, ECG, and clinical laboratory values (hematology, chemistry, and urinalysis). Exclusion Criteria: 1. Have a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder or substance (other than nicotine or caffeine) use disorder within past 12 months or for a total of >= 10 years during the subject's lifetime, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and posttraumatic stress disorder. Symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms have not been a focus of primary treatment 2. At significant risk of harming self, others, or objects based on Investigator's judgment. 3. Have any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study. 4. Female subjects who are pregnant or lactating. 5. Have any clinically significant abnormal laboratory value(s) at Screening (hematology, chemistry, and urinalysis) as determined by the Investigator.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
SEP-363856
SEP-363856 50 mg or 75 mg, flexibly dosed once daily tablet for 52 weeks

Locations

Country Name City State
Japan Takeda General Hospital Aizuwakamatsu-shi Fukushima
Japan Heart Care Clinic Omachi Akita-shi Akita
Japan Ishigooka Hospital Chiba-shi Chiba
Japan Ryokuwakai Stresscare Hibiya Clinic Chiyoda-ku Tokyo
Japan Tatsuta Clinic Chuo-ku, Kobe-shi Hyogo
Japan Murakami Hospital Edogawa-ku Tokyo
Japan Fukui Hospital Fukui-shi Fukui
Japan Ai Sakura Clinic Fukuoka-shi Fukuoka
Japan Inokuchi Noma Hospital Fukuoka-shi Fukuoka
Japan Kuramitsu Hospital Fukuoka-shi Fukuoka
Japan Medical corporation Shinseikai Kaku Mental Clinic Fukuoka-shi Fukuoka
Japan Mental Clinic Sakurazaka Fukuoka-shi Fukuoka
Japan Seinan Hospital Hachinohe-shi Aomori
Japan Kohnodai Hospital National Center for Global Health and Medicine Ichikawa-shi Chiba
Japan Narimasu Kosei Hospital Itabashi-ku Tokyo
Japan NHO Hizen Psychiatric Center Kanzaki-gun Saga
Japan Rainbow & Sea Hospital Karatsu-shi Saga
Japan Kishiro Mental Clinic Kawasaki-shi Kanagawa
Japan Musashikosugi J Kokorono Clinic Kawasaki-shi Kanagawa
Japan Medical Corporation Kishikai Kishi Hospital Kiryu-shi Gunma
Japan Tosa Hospital Kochi-shi Kochi
Japan Hotei Hospital Konan-shi Aichi
Japan Nishi Kumagaya Hospital Kumagaya-shi Saitama
Japan Kouyoudai Hospital Kumamoto-shi Kumamoto
Japan Satokai Yuge Hospital Kumamoto-shi Kumamoto
Japan NHO Ryukyu Hospital Kunigami-gun Okinawa
Japan Hayakawa Clinic Kure-shi Hiroshima
Japan NHO Kure Medical Center and Chugoku Cancer Center Kure-shi Hiroshima
Japan Ozawa Mental Clinic Matsumoto-shi Nagano
Japan Senzoku Psychosomatic Medicine Clinic Meguro-ku Tokyo
Japan Miyazaki Prefectural Miyazaki Hospital Miyazaki-shi Miyazaki
Japan Kansai Medical University Medical Center Moriguchi-shi Osaka
Japan Keihan Hospital Moriguchi-shi Osaka
Japan Akari Clinic Naha-shi Okinawa
Japan Miebashi Clinic Naha-shi Okinawa
Japan Okayama Psychiatric Medical Center Okayama-shi Okayama
Japan Shiranui Hospital Omuta-shi Fukuoka
Japan Mental Clinic Minami Saitama-shi Saitama
Japan Sanyo Hospital Sakata-shi Yamagata
Japan Goryokai Hospital Sapporo-shi Hokkaido
Japan Sakura-shinmachi Mental Clinic Setagaya-ku Tokyo
Japan Sangenjaya Neurology- Psychosomatic Clinic Setagaya-ku Tokyo
Japan Sangubashi Kokorono Clinic Shibuya-ku Tokyo
Japan Ohwa Mental Clinic Toshima-ku Tokyo
Japan Inuo Mental Care Hospital Tosu-shi Saga
Japan Barclay Imuro Mental Clinic Urasoe-shi Okinawa
Japan Shiroma Clinic Urasoe-shi Okinawa
Japan Yamagata Sakuracho Hospital Yamagata-shi Yamagata
Japan Hino Hospital Yokohama-shi Kanagawa
Japan Miki Mental Clinic Yokohama-shi Kanagawa
Japan Yamatenomori Kokorono Clinic Yokohama-shi Kanagawa

Sponsors (1)

Lead Sponsor Collaborator
Sumitomo Pharma Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The incidence of overall adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation. Evaluate the long-term safety and tolerability of flexible dosed SEP-363856 (50 and 75 mg/day) in subjects with schizophrenia by the incidence of overall adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation. Week 52
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