Recruiting NCT06579573
ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cenobamate.
- Who it may be relevant to
- Registry conditions: Epilepsy, Generalized. Basic parameters: from 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
ONO-2017 Phase III Study A Multicenter, Open-label Study in Japanese Patients With Primary Generalized Tonic Clonic Seizures.
Overview
To investigate the efficacy and safety of ONO-2017 in combination with antiepileptics in Japanese epileptic patients with generalized tonic-clonic seizures.
Interventions
- Drug Cenobamate
Cenobamate will be orally administered once daily.
Primary outcome measures
- Percentage Change in generalized tonic-clonic (PGTC) seizure frequency per 28-Day Interval [Time frame: 12 Weeks of the Maintenance Phase]
Secondary outcome measures (2)
- Percentage Change in all generalized seizure frequency per 28-Day [Time frame: 12 Weeks of the Maintenance Phase]
- Percentage of Subjects with Reduction in Generalized Seizure Frequency per 28-Day Interval [Time frame: 12 Weeks of the Maintenance Phase]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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 necrolysis, drug reaction with eosinophilia and systemic symptoms(DRESS), Drug-induced hypersensitivity syndrome(DIHS)) or any drug-related rash requiring hospitalization.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Japan · 25 centers
- Aichi Medical University Hospital — Aichi
- Hospital of the University of Occupational and Environmental Health, Japan — Fukuoka
- Southern TOHOKU Research Institute for Neuroscience Southern TOHOKU Medical Clinic — Fukushima
- Local Independent Administrative Corporation Hiroshima City Hospital Organization Hiroshim — Hiroshima
- Hokkaido University Hospital — Hokkaido
- Itami City Hospital — Hyōgo
- Tsuchiura Kyodo General Hospita — Ibaraki
- University of Tsukuba Hospital — Ibaraki
- … and 17 more centers
Identifiers
NCT: NCT06579573 · ONO-2017-01 · jRCT2031210624