Partial Epilepsy
Conditions
Brief summary
Primary objective: To evaluate the safety and tolerability of cenobamate in Japanese pediatric subjects 2-17 years of age with partial-onset (focal) seizures
Detailed description
Secondary objectives: To evaluate the efficacy of cenobamate tablets and suspension in Japanese pediatric subjects with partial onset (focal) seizures To evaluate the pharmacokinetics of cenobamate tablets and suspension in Japanese pediatric subjects with partial onset seizures
Interventions
DRUGCenobamate (tablet) for 12 to < 18 year olds
The tablet form of ONO-2017 will be initiated at a dose of 12.5 mg once daily and titrated in the specified method to a target dose of 200 mg per day. The daily dose may be increased/reduced as appropriate according to symptoms within the range not exceeding 400 mg. In addition, depending on clinical response and tolerability, dose titration may be stopped at a dose of ≥ 50 mg per day to establish the maintenance dose. In principle, all doses should be taken with an appropriate amount of water in the morning. The dosage form for the doses will be selected by the principal investigator or designee. ONO-2017 can be treated until ONO-2017 is market approved, enters the market, and becomes available for supply to the study site.
DRUGCenobamate (syrup) for 2 to < 18 year olds
The syrup form of ONO-2017 will be administered at a dose equivalent to that for 12-18 year olds on a body weight basis
Sponsors
Ono Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events and adverse drug reactions | 1 year |
Countries
Japan
Contacts
CONTACTNorth America Clinical Trial Support Desk
CONTACTInternational Clinical Trial Support Desk
STUDY_DIRECTORProject Leader
Ono PharmaceuticalCo., Ltd.
Outcome results
None listed