Actively Recruiting
A Multicenter, Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ONO-2017 in Japanese Patients With Partial Onset Seizures Aged 2 to Under 18 Years
Led by Ono Pharmaceutical Co., Ltd. · Updated on 2026-05-18
20
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, effectiveness, and how the body processes a drug called cenobamate in Japanese children aged 2 to under 18 years who have partial-onset (focal) seizures. This study aims primarily to assess the safety and tolerability of cenobamate in this young population. Secondary goals include evaluating the drug's effectiveness and pharmacokinetics in these patients. Participants will receive cenobamate either as tablets or syrup depending on their age and body weight. For children aged 12 to under 18 years, the tablet form will start at 12.5 mg once daily and gradually increase to a target dose of 200 mg per day, with possible adjustments based on symptoms and tolerability, not exceeding 400 mg daily. The syrup form is given to children 2 to under 18 years at doses adjusted for body weight. Treatment continues until the drug is approved and available on the market. During the study, participants will be monitored for adverse events and drug reactions over one year. Researchers will collect detailed seizure information from patient diaries and assess treatment effects and safety regularly. The study includes stable use of other seizure medications at baseline and requires consistent follow-up to observe outcomes and ensure participant safety throughout the study period.
CONDITIONS
Brief Title
A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year Olds
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Japanese male or female patients aged 2 to under 18 years at the time of informed consent
- Diagnosed with epilepsy having partial-onset seizures with uncontrolled seizures for at least 6 months prior to consent
- Experienced at least one partial-onset seizure in the 4 weeks before registration, with seizure details available from patient diaries
- Treated with 1 to 3 anti-seizure medications at stable doses for at least 2 months before registration
You will not qualify if you...
- History of status epilepticus requiring hospitalization within 3 months before registration
- History of non-epileptic psychogenic seizures
- Simple partial seizures without motor symptoms or idiopathic generalized epilepsy
- Diagnosis of Lennox-Gastaut syndrome
- History of serious drug-induced hypersensitivity reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, or drug-induced hypersensitivity syndrome requiring hospitalization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants receive cenobamate tablets or syrup with doses adjusted based on age and clinical response to control partial onset seizures.
Regular visits to adjust dosage and monitor safety
Trial Site Locations
Total: 1 location
1
Japan Red Cross Fukuoka Hospital
Fukuoka, Japan
Actively Recruiting
Research Team
N
North America Clinical Trial Support Desk
I
International Clinical Trial Support Desk
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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