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A Long-term Administration Trial of SEP-363856 in Patients With Schizophrenia

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Dec 2025 to Dec 22, 2025 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Dec 2025 to Dec 22, 2025
    • Site details revised
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
To evaluate the safety of SEP-363856 (75 mg/day or 100 mg/day) administered for 52 weeks in adult participants with schizophrenia
Trial Details
NCT Number NCT07225712
Lead Sponsor Otsuka Pharmaceutical Co., Ltd.
Conditions Schizophrenia
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov