Partial onset seizures in epilepsy patients (including secondarily generalized seizures)
Conditions
Interventions
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 or reduced as appropriate according
Sponsors
Hirashima Yoshinori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Japanese male or female patients aged 2 to under 18 years at the time ofinformed consent. - Patients diagnosed with epilepsy as having POS with uncontrolled seizuresat least 6 months prior to informed consent, regardless of the presence orabsence 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 forat least 2 months before registration
Exclusion criteria
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 reaction | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change from the pre-observation period in seizure frequency per 28 days during the treatment period and in each phase | — |
Contacts
Public ContactSupport Desk JP
Ono Pharmaceutical Co.,LTD.
Outcome results
None listed