Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures

Sponsor
Ono Pharmaceutical Co., Ltd.
Study ID
NCT06590896
Phase
PHASE2
Status
Recruiting
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Conditions

  • Epilepsies, Partial

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cenobamate — DRUG
    Cenobamate will be orally administered once daily.

Study Details

To evaluate the long-term safety and tolerability of cenobamate in Japanese epilepsy patients with partial seizures

Key Dates

Start date
Nov 4, 2022
Status verified
Jun 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cenobamate

Primary Outcome Measure

Incidences of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Through study completion, an average of 4 years ]

Central Contacts

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