A Clinical Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan

Sponsor

Sumitomo Pharma Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05359081

Collaborator

(none)

220

Enrollment

Locations

Arm

34.5

Anticipated Duration (Months)

4.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: SEP-363856	Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

220 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A 52-week, Open-label Study to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan

Actual Study Start Date :

May 16, 2022

Anticipated Primary Completion Date :

Mar 31, 2025

Anticipated Study Completion Date :

Mar 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SEP-363856 SEP-363856 (50 or 75 mg/day, flexible dose)	Drug: SEP-363856 SEP-363856 50 mg or 75 mg, flexibly dosed once daily tablet for 52 weeks

Arm

Intervention/Treatment

Experimental: SEP-363856

SEP-363856 (50 or 75 mg/day, flexible dose)

Drug: SEP-363856

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

Outcome Measures

Primary Outcome Measures

The incidence of overall adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation. [Week 52]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.
Male or female between 18 to 65 years of age (inclusive) at the time of consent.
Must meet DSM 5 criteria for schizophrenia as established by clinical interview at Screening
Must have a PANSS total score >=60 at Screening and Baseline.
Must have a CGI-S score >=3 at Screening and Baseline
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
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:

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
At significant risk of harming self, others, or objects based on Investigator's judgment.
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.
Female subjects who are pregnant or lactating.
Have any clinically significant abnormal laboratory value(s) at Screening (hematology, chemistry, and urinalysis) as determined by the Investigator.

Contacts and Locations

Locations

	Site	City	State	Country
1	Hotei Hospital	Konan-shi	Aichi	Japan
2	Heart Care Clinic Omachi	Akita-shi	Akita	Japan
3	Seinan Hospital	Hachinohe-shi	Aomori	Japan
4	Ishigooka Hospital	Chiba-shi	Chiba	Japan
5	Kohnodai Hospital National Center for Global Health and Medicine	Ichikawa-shi	Chiba	Japan
6	Fukui Hospital	Fukui-shi	Fukui	Japan
7	Ai Sakura Clinic	Fukuoka-shi	Fukuoka	Japan
8	Inokuchi Noma Hospital	Fukuoka-shi	Fukuoka	Japan
9	Kuramitsu Hospital	Fukuoka-shi	Fukuoka	Japan
10	Mental Clinic Sakurazaka	Fukuoka-shi	Fukuoka	Japan
11	Shiranui Hospital	Omuta-shi	Fukuoka	Japan
12	Takeda General Hospital	Aizuwakamatsu-shi	Fukushima	Japan
13	Medical Corporation Kishikai Kishi Hospital	Kiryu-shi	Gunma	Japan
14	Hayakawa Clinic	Kure-shi	Hiroshima	Japan
15	NHO Kure Medical Center and Chugoku Cancer Center	Kure-shi	Hiroshima	Japan
16	Goryokai Hospital	Sapporo-shi	Hokkaido	Japan
17	Tatsuta Clinic	Chuo-ku, Kobe-shi	Hyogo	Japan
18	Kishiro Mental Clinic	Kawasaki-shi	Kanagawa	Japan
19	Musashikosugi J Kokorono Clinic	Kawasaki-shi	Kanagawa	Japan
20	Hino Hospital	Yokohama-shi	Kanagawa	Japan
21	Miki Mental Clinic	Yokohama-shi	Kanagawa	Japan
22	Yamatenomori Kokorono Clinic	Yokohama-shi	Kanagawa	Japan
23	Tosa Hospital	Kochi-shi	Kochi	Japan
24	Kouyoudai Hospital	Kumamoto-shi	Kumamoto	Japan
25	Satokai Yuge Hospital	Kumamoto-shi	Kumamoto	Japan
26	Miyazaki Prefectural Miyazaki Hospital	Miyazaki-shi	Miyazaki	Japan
27	Ozawa Mental Clinic	Matsumoto-shi	Nagano	Japan
28	Okayama Psychiatric Medical Center	Okayama-shi	Okayama	Japan
29	NHO Ryukyu Hospital	Kunigami-gun	Okinawa	Japan
30	Akari Clinic	Naha-shi	Okinawa	Japan
31	Barclay Imuro Mental Clinic	Urasoe-shi	Okinawa	Japan
32	Kansai Medical University Medical Center	Moriguchi-shi	Osaka	Japan
33	Keihan Hospital	Moriguchi-shi	Osaka	Japan
34	NHO Hizen Psychiatric Center	Kanzaki-gun	Saga	Japan
35	Rainbow & Sea Hospital	Karatsu-shi	Saga	Japan
36	Inuo Mental Care Hospital	Tosu-shi	Saga	Japan
37	Nishi Kumagaya Hospital	Kumagaya-shi	Saitama	Japan
38	Mental Clinic Minami	Saitama-shi	Saitama	Japan
39	Ryokuwakai Stresscare Hibiya Clinic	Chiyoda-ku	Tokyo	Japan
40	Murakami Hospital	Edogawa-ku	Tokyo	Japan
41	Narimasu Kosei Hospital	Itabashi-ku	Tokyo	Japan
42	Senzoku Psychosomatic Medicine Clinic	Meguro-ku	Tokyo	Japan
43	Sakura-shinmachi Mental Clinic	Setagaya-ku	Tokyo	Japan
44	Sangenjaya Neurology- Psychosomatic Clinic	Setagaya-ku	Tokyo	Japan
45	Sangubashi Kokorono Clinic	Shibuya-ku	Tokyo	Japan
46	Ohwa Mental Clinic	Toshima-ku	Tokyo	Japan
47	Sanyo Hospital	Sakata-shi	Yamagata	Japan

Sponsors and Collaborators

Sumitomo Pharma Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sumitomo Pharma Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05359081

Other Study ID Numbers:

DA801202

First Posted:

May 3, 2022

Last Update Posted:

Jul 7, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Schizophrenia

Study Results

No Results Posted as of Jul 7, 2022