A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year Olds
Recruiting · NCT07594158 · Interventional (participants receive a specific treatment) · Lead sponsor: Ono Pharmaceutical Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
Cenobamate (syrup) for 2 to < 18 year oldsCenobamate (tablet) for 12 to < 18 year olds
What this trial is about
Primary objective: To evaluate the safety and tolerability of cenobamate in Japanese pediatric subjects 2-17 years of age with partial-onset (focal) seizures
Who can take part
Age range
2 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Japan Red Cross Fukuoka Hospital - Fukuoka, Japan