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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

RecruitingPhase 3

Sponsor: Ono Pharmaceutical Co., Ltd.

Conditions: Partial Epilepsy

Interventions: Cenobamate (tablet) for 12 to < 18 year olds, Cenobamate (syrup) for 2 to < 18 year olds

Countries: Japan

Primary objective: To evaluate the safety and tolerability of cenobamate in Japanese pediatric subjects 2-17 years of age with partial-onset (focal) seizures

Eligibility overview

Sex: ALL

Age: 2 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Japanese male or female patients aged 2 to under 18 years at the time of informed consent.
* Patients diagnosed with epilepsy as having POS with uncontrolled seizures at least 6 months prior to informed consent, regardless of the presence or absence of secondarily generalized seizures.
* Patients who have had POS at least once in 4 weeks before registration. Seizure information can be obtained from the participant's own retrospective patient epilepsy diary, etc.
* Participants must have been treated with 1 to 3 ASMs at stable doses for at least 2 months before registration.

Exclusion Criteria:

* Patients with a history of status epilepticus requiring hospitalization within 3 months before registration.
* Patients with a history of non-epileptic psychogenic seizures.
* Patients with simple partial seizures without motor symptoms or idiopathic generalized epilepsy.
* Patients diagnosed with Lennox-Gastaut syndrome.
* Patients with a history of serious drug-induced hypersensitivity reaction (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, drug-induced hypersensitivity syndrome \[DIHS\]) or drug-induced rash requiring hospitalization.

Locations (1)

Fukuoka, Japan