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

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Sumitomo Pharma

Status and phase

Terminated
Phase 3

Conditions

Schizophrenia

Treatments

Drug: SEP-363856

Study type

Interventional

Funder types

Industry

Identifiers

NCT05359081
DA801202

Details and patient eligibility

About

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

Full 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.

Enrollment

68 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

68 participants in 1 patient group

SEP-363856
Experimental group
Description:
SEP-363856 (50 or 75 mg/day, flexible dose)
Treatment:
Drug: SEP-363856

Trial contacts and locations

51

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Central trial contact

Sumitomo Pharma Co., Ltd.

Data sourced from clinicaltrials.gov

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