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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Cenobamate
DrugCenobamate will be orally administered once daily.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: CenobamateExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage Change in generalized tonic-clonic (PGTC) seizure frequency per 28-Day Interval
Convert the frequency of generalized tonic-clonic seizures (PGTC) in the Maintenance Phase and Pre-treatment Phase to a 28-day interval. Calculate the percentage change for these.
Time frame
12 Weeks of the Maintenance PhaseSecondary outcomes
1
Percentage Change in all generalized seizure frequency per 28-Day
Convert the frequency of all generalized seizures in the Maintenance Phase and Pre-treatment Phase to a 28-day interval. Calculate the percentage change for these.
Time frame
12 Weeks of the Maintenance Phase2
Percentage of Subjects with Reduction in Generalized Seizure Frequency per 28-Day Interval
The percentage of subjects who have a 50%, 75%, 90%, and 100% reduction in all generalized seizure frequency per 28-day interval during the Maintenance Phase relative to the Pre-treatment Phase
Time frame
12 Weeks of the Maintenance PhaseSponsors and contacts
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Source ClinicalTrials.gov