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 groupSponsors and collaborators
Source ClinicalTrials.gov