💬In plain words
What the trial is, and whether it could suit you
Primary objective: To evaluate the safety and tolerability of cenobamate in Japanese pediatric subjects 2-17 years of age with partial-onset (focal) seizures
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
💊
What it tests
- Cenobamate (tablet) for 12 to < 18 year olds
- Cenobamate (syrup) for 2 to < 18 year olds
Japan Red Cross Fukuoka Hospital
Fukuoka, Japan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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