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Tests treatment safety and results for Partial Epilepsy
Official title A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year Olds
ClinicalTrials.gov ID: NCT07594158
What this study is testing
What is Cenobamate (tablet) for 12 to < 18 year olds?
Cenobamate (tablet) for 12 to < 18 year olds is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for partial epilepsy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Primary objective: To evaluate the safety and tolerability of cenobamate in Japanese pediatric subjects 2-17 years of age with partial-onset (focal) seizures
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- 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...
- Patients who have had POS at least once in 4 weeks before registration. Seizure information can be obtained from the participant's own retrospective...
- Participants must have been treated with 1 to 3 ASMs at stable doses for at least 2 months before registration.
You likely can't join if
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Fukuoka, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fukuoka, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.