jRCT2071260025RecruitingNot Applicable
ONO-2017-04: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.
Not provided0 sites20 target enrollmentStarted: TBD
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Single Arm Study
Eligibility Criteria
- Ages
- 2age old over to 18age old not (—)
- Sex
- All
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
- •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
Investigators
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