ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures.

Sponsor
Ono Pharmaceutical Co., Ltd.
Study ID
NCT06579573
Phase
PHASE3
Status
Recruiting
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Conditions

  • Epilepsy, Generalized

Eligibility Criteria

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

Interventions

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

Study Details

To investigate the efficacy and safety of ONO-2017 in combination with antiepileptics in Japanese epileptic patients with generalized tonic-clonic seizures.

Key Dates

Start date
Jul 12, 2022
Status verified
Jun 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

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

Arms

  • Experimental: Cenobamate

Primary Outcome Measure

Percentage Change in generalized tonic-clonic (PGTC) seizure frequency per 28-Day Interval [ Time Frame: 12 Weeks of the Maintenance Phase ]

Central Contacts

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