ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures.
ConditionEpilepsy, Generalized
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorOno Pharmaceutical Co., Ltd.
About this trial
To investigate the efficacy and safety of ONO-2017 in combination with antiepileptics in Japanese epileptic patients with generalized tonic-clonic seizures.
Eligibility criteria
Qualifiers
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
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Cenobamate
Treatment groups
15 Participants
are divided into 1 treatment groupLocations
25Aichi Medical University Hospital Aichi Japan
Hospital of the University of Occupational and Environmental Health, Japan Fukuoka Japan
Southern TOHOKU Research Institute for Neuroscience Southern TOHOKU Medical Clinic Fukushima Japan
Local Independent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital Hiroshima Japan
Sponsors and collaborators
Ono Pharmaceutical Co., Ltd.
Lead sponsor
Source ClinicalTrials.gov