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A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year Olds

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date changed from estimate of May 30, 2026 to Jun 10, 2026 Interventions: Cenobamate (syrup) for 2 to < 18 year olds (Drug), Cenobamate (tablet) for 12 to < 18 year olds (Drug) to Cenobamate (syrup) for 2 to < 18 year olds (Drug), Cenobamate (tablet) for 12 to < 18 year olds (Drug) · Eligibility criteria expanded, about 9 words Show 2 more changesShow less
    • Interventions: Cenobamate (syrup) for 2 to < 18 year olds (Drug), Cenobamate (tablet) for 12 to < 18 year olds (Drug) to Cenobamate (syrup) for 2 to < 18 year olds (Drug), Cenobamate (tablet) for 12 to < 18 year olds (Drug)
    • Eligibility criteria expanded, about 9 words
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Primary objective: To evaluate the safety and tolerability of cenobamate in Japanese pediatric subjects 2-17 years of age with partial-onset (focal) seizures
Trial Details
NCT Number NCT07594158
Lead Sponsor Ono Pharmaceutical Co., Ltd.
Conditions Partial Epilepsy
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov