Clinical trial NCT06590896: Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures
Official title: A Phase 2, Multicenter Open-Label Extension Study to Evaluate the Long-term Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Epilepsies, Partial
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the long-term safety and tolerability of cenobamate in Japanese epilepsy patients with partial seizures


Eligibility criteria: Inclusion Criteria:

* Subjects completed Study YKP3089C035 by SK Life Science.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Incidences of Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Through study completion, an average of 4 years
measure: Urinalysis(pH)
timeFrame: Through study completion, an average of 4 years
measure: Urinalysis(Specific Gravity)
timeFrame: Through study completion, an average of 4 years
measure: Urinalysis(Protein)
timeFrame: Through study completion, an average of 4 years
measure: Urinalysis(Glucose)
timeFrame: Through study completion, an average of 4 years
measure: Urinalysis(Ketone)
timeFrame: Through study completion, an average of 4 years
measure: Urinalysis(Bilirubin)
timeFrame: Through study completion, an average of 4 years
measure: Urinalysis(Blood)
timeFrame: Through study completion, an average of 4 years
measure: Urinalysis(Nitrite)
timeFrame: Through study completion, an average of 4 years
measure: Urinalysis(Urobilinogen)
timeFrame: Through study completion, an average of 4 years
measure: Urinalysis( Microscopic Examination)
timeFrame: Through study completion, an average of 4 years
measure: Liver function tests(total protein)
timeFrame: Through study completion, an average of 4 years
measure: Liver function tests(albumin)
timeFrame: Through study completion, an average of 4 years
measure: Liver function tests(total bilirubin)
timeFrame: Through study completion, an average of 4 years
measure: Liver function tests(aspartate transaminase)
timeFrame: Through study completion, an average of 4 years
measure: Liver function tests(alanine aminotransferase)
timeFrame: Through study completion, an average of 4 years
measure: Liver function tests(alkaline phosphatase)
timeFrame: Through study completion, an average of 4 years
measure: Liver function tests(gamma-glutamyl transferase)
timeFrame: Through study completion, an average of 4 years
measure: Hematology(Hemoglobin)
timeFrame: Through study completion, an average of 4 years
measure: Hematology(hematocrit)
timeFrame: Through study completion, an average of 4 years
measure: Hematology(white blood cell count)
timeFrame: Through study completion, an average of 4 years
measure: Hematology(red blood cell count)
timeFrame: Through study completion, an average of 4 years
measure: Hematology(mean corpuscular volume)
timeFrame: Through study completion, an average of 4 years
measure: Hematology(mean corpuscular hemoglobin)
timeFrame: Through study completion, an average of 4 years
measure: Hematology(red blood cell distribution width)
timeFrame: Through study completion, an average of 4 years
measure: Hematology(platelet count)
timeFrame: Through study completion, an average of 4 years
measure: Serum chemistry(blood urea nitrogen)
timeFrame: Through study completion, an average of 4 years
measure: Serum chemistry(calcium)
timeFrame: Through study completion, an average of 4 years
measure: Serum chemistry(chloride)
timeFrame: Through study completion, an average of 4 years
measure: Serum chemistry(creatinine)
timeFrame: Through study completion, an average of 4 years
measure: Serum chemistry(total bilirubin)
timeFrame: Through study completion, an average of 4 years
measure: Serum chemistry(direct bilirubin)
timeFrame: Through study completion, an average of 4 years
measure: Serum chemistry(alkaline phosphatase)
timeFrame: Through study completion, an average of 4 years
measure: Serum chemistry(alanine aminotransferase)
timeFrame: Through study completion, an average of 4 years
measure: Serum chemistry(gamma-glutamyl transferase)
timeFrame: Through study completion, an average of 4 years
measure: Serum chemistry(total protein)
timeFrame: Through study completion, an average of 4 years
measure: Serum chemistry(albumin)
timeFrame: Through study completion, an average of 4 years
measure: Serum chemistry(globulin)
timeFrame: Through study completion, an average of 4 years
measure: Serum chemistry(sodium)
timeFrame: Through study completion, an average of 4 years
measure: Serum chemistry(potassium)
timeFrame: Through study completion, an average of 4 years
measure: Serum chemistry(phosphorus)
timeFrame: Through study completion, an average of 4 years
measure: Serum chemistry(glucose)
timeFrame: Through study completion, an average of 4 years
measure: Heart rate
timeFrame: Through study completion, an average of 4 years
measure: Respiratory Rate
timeFrame: Through study completion, an average of 4 years
measure: Blood Pressure
timeFrame: Through study completion, an average of 4 years
measure: Electrocardiogram (ECG) Findings
timeFrame: Through study completion, an average of 4 years
measure: Columbia-Suicide Severity Rating Scale (C-SSRS) Scores
timeFrame: Through study completion, an average of 4 years
Secondary outcomes:
measure: Percentage Change in all partial seizure frequency per 28-Day
timeFrame: Through study completion, an average of 4 years
Other outcomes:
Locations:
city: Ehime
country: Japan
facility: Ehime University Hospital
city: Fukushima
country: Japan
facility: Department of Neurology and Stroke Center, Southern Tohoku Clinic.
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Hiroshima
country: Japan
facility: NHO Kure Medical Center and Chugoku Cancer Center
city: Hokkaido
country: Japan
facility: Asahikawa Medical University Hospital
city: Hyōgo
country: Japan
facility: Itami City Hospital
city: Ibaraki
country: Japan
facility: JA-Ibaraki Tsuchiura Kyodo General Hospital
city: Ibaraki
country: Japan
facility: University of Tsukuba Hospital
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Kagoshima
country: Japan
facility: Tanaka Neurosurgical Clinic
city: Kanagawa
country: Japan
facility: St. Marianna University School of Medicine Hospital
city: Kanagawa
country: Japan
facility: Yokohama City University Hospital
city: Kumamoto
country: Japan
facility: Kumamoto Ezuko Rehabilitation Medical Center
city: Nagasaki
country: Japan
facility: NHO Nagasaki Medical Center
city: Osaka
country: Japan
facility: Koide Clinic of Epilepsy and Neurological Disorders
city: Osaka
country: Japan
facility: Osaka University Hospital
city: Osaka
country: Japan
facility: Shintokukai Nii Neurosurgery and Psychiatry Clinic
city: Saitama
country: Japan
facility: Ochiai Brain Clinic
city: Saitama
country: Japan
facility: TMG ASAKA Medical Center
city: Shiga
country: Japan
facility: Sakurai Clinic
city: Shizuoka
country: Japan
facility: NHO Shizuoka Institute of Epilepsy and Neurological Disorders
city: Shizuoka
country: Japan
facility: Seirei Hamamatsu General Hospital
city: Shizuoka
country: Japan
facility: Seirei Mikatahara General Hospital
city: Tochigi
country: Japan
facility: Jichi Medical University Hospital
city: Tokushima
country: Japan
facility: Tokushima University Hospital
city: Tokyo
country: Japan
facility: Medical Hospital, Tokyo Medical and Dental University
city: Tokyo
country: Japan
facility: National Center of Neurology and Psychiatry
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
city: Yamagata
country: Japan
facility: NHO Yamagata National Hospital
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader
role: STUDY_DIRECTOR
References: