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New treatment option for Epilepsy, Generalized
Official title ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures.
ClinicalTrials.gov ID: NCT06579573
What this study is testing
What is Cenobamate?
Cenobamate is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for epilepsy, generalized.
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
- To investigate the efficacy and safety of ONO-2017 in combination with antiepileptics in Japanese epileptic patients with generalized tonic-clonic 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 12 and older
You may be able to join if
- Gender and age: Japanese patients, regardless of gender, aged 12 years or older at the time of informed consent.
- Subject has a clinical diagnosis of Primary Generalized Tonic-Clonic (PGTC) seizures in the setting of idiopathic generalized epilepsy.
- Subject experiences at least 5 Primary Generalized Tonic-Clonic (PGTC) seizures in 12 weeks.
- Subject is currently receiving 1 to a maximum of 3 concomitant Antiepileptic Drugs(AEDs) with fixed dosing regimens
You likely can't join if
- Subject has a history of status epilepticus that required hospitalization within 15 months prior to enrollment.
- Subject has seizure clusters where individual seizures cannot be counted orclassified.
- History of non-epileptic or psychogenic seizures.
- Subject has a concomitant diagnosis of Partial Onset Seizure(POS).
- Subject has a history of any serious drug-induced hypersensitivity reaction (including but not limited to Stevens Johnson syndrome, toxic epidermal...
The study team makes the final eligibility decision.
Where it's taking place
- Aichi, Japan
- Fukuoka, Japan
- Fukushima, Japan
- Hiroshima, Japan
- Hokkaido, Japan
- Hyōgo, Japan
- Ibaraki, Japan
- Kagoshima, Japan
- Kanagawa, Japan
- Niigata, Japan
- Osaka, Japan
- Saitama, Japan
- Shizuoka, Japan
- Tochigi, Japan
- Tokyo, Japan
- Yamaguchi, Japan
- Yamanashi, 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, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aichi, Japan; Fukuoka, Japan; Fukushima, Japan; Hiroshima, Japan; Hokkaido, Japan; Hyōgo, Japan and 11 more location(s). 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.