Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures
ConditionEpilepsies, Partial
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorOno Pharmaceutical Co., Ltd.
About this trial
To evaluate the long-term safety and tolerability of cenobamate in Japanese epilepsy patients with partial seizures
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects completed Study YKP3089C035 by SK Life Science.
Disqualifiers
Subjects that have previously discontinued for any reason from the Core study (YKP3089C035).
Any significant changes to the medical history of the subject that in the opinion of the investigator, could affect the safety of the subject.
Trial design
Design model
Single group
Treatments tested in this trial
Cenobamate
DrugCenobamate will be orally administered once daily.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: CenobamateExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidences of Adverse Events (AEs) and Serious Adverse Events (SAEs)
The incidences of adverse events (AEs) and serious adverse events (SAEs) will be recorded.
Time frame
Through study completion, an average of 4 years2
Urinalysis(pH)
Measurement of urine pH.
Time frame
Through study completion, an average of 4 years3
Urinalysis(Specific Gravity)
Measurement of urine specific gravity (g/mL).
Time frame
Through study completion, an average of 4 years4
Urinalysis(Protein)
Measurement of urine protein (mg/dL).
Time frame
Through study completion, an average of 4 yearsSecondary outcomes
1
Percentage Change in all partial seizure frequency per 28-Day
It will confirm the frequency of partial seizures at 28-day intervals and calculate the percentage change until the study is completed.
Time frame
Through study completion, an average of 4 yearsSponsors and contacts
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Source ClinicalTrials.gov