A clinical study to investigate the long-term safety and torelability of SEP-363856 in clinically stable adult patients with schizophrenia in Japan.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
68
SEP-363856 50 mg or 75 mg, flexibly dosed once daily tablet for 52 weeks
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.
Time frame: Week 52
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