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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05359081
• Other study ID #: DA801202
• Status: Terminated
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Schizophrenia

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