Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures

Condition(s) studied

Investigational drug(s) / intervention(s)

Cenobamate: Cenobamate will be orally administered once daily.

Study summary

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

Eligibility

Primary outcome measure(s)

• Incidences of Adverse Events (AEs) and Serious Adverse Events (SAEs) — Through study completion, an average of 4 years
  The incidences of adverse events (AEs) and serious adverse events (SAEs) will be recorded.
• Urinalysis(pH) — Through study completion, an average of 4 years
  Measurement of urine pH.
• Urinalysis(Specific Gravity) — Through study completion, an average of 4 years
  Measurement of urine specific gravity (g/mL).
• Urinalysis(Protein) — Through study completion, an average of 4 years
  Measurement of urine protein (mg/dL).
• Urinalysis(Glucose) — Through study completion, an average of 4 years
  Measurement of urine glucose (mg/dL).
• Urinalysis(Ketone) — Through study completion, an average of 4 years
  Measurement of urine ketone (mg/dL).
• Urinalysis(Bilirubin) — Through study completion, an average of 4 years
  Measurement of urine bilirubin (mg/dL).
• Urinalysis(Blood) — Through study completion, an average of 4 years
  Measurement of urine blood (presence/absence).
• Urinalysis(Nitrite) — Through study completion, an average of 4 years
  Measurement of urine nitrite (presence/absence).
• Urinalysis(Urobilinogen) — Through study completion, an average of 4 years
  Measurement of urine urobilinogen (mg/dL).
• Urinalysis( Microscopic Examination) — Through study completion, an average of 4 years
  Microscopic examination of urine (if abnormal).
• Liver function tests(total protein) — Through study completion, an average of 4 years
  Measurement of total protein(g/dL)
• Liver function tests(albumin) — Through study completion, an average of 4 years
  Measurement of albumin(g/dL)
• Liver function tests(total bilirubin) — Through study completion, an average of 4 years
  Measurement of total bilirubin(mg/dL)
• Liver function tests(aspartate transaminase) — Through study completion, an average of 4 years
  Measurement of aspartate transaminase(U/L)
• Liver function tests(alanine aminotransferase) — Through study completion, an average of 4 years
  Measurement of alanine aminotransferase(U/L)
• Liver function tests(alkaline phosphatase) — Through study completion, an average of 4 years
  alkaline phosphatase(U/L)
• Liver function tests(gamma-glutamyl transferase) — Through study completion, an average of 4 years
  Measurement of gamma-glutamyl transferase(U/L)
• Hematology(Hemoglobin) — Through study completion, an average of 4 years
  Measurement of hemoglobin(g/dL)
• Hematology(hematocrit) — Through study completion, an average of 4 years
  Measurement of hematocrit(%)
• Hematology(white blood cell count) — Through study completion, an average of 4 years
  Measurement of white blood cell count（/μL）
• Hematology(red blood cell count) — Through study completion, an average of 4 years
  Measurement of red blood cell count（/μL)
• Hematology(mean corpuscular volume) — Through study completion, an average of 4 years
  Measurement of mean corpuscular volume(fL)
• Hematology(mean corpuscular hemoglobin) — Through study completion, an average of 4 years
  Measurement of mean corpuscular hemoglobin(pg)
• Hematology(red blood cell distribution width) — Through study completion, an average of 4 years
  Measurement of red blood cell distribution width(％)
• Hematology(platelet count) — Through study completion, an average of 4 years
  Measurement of platelet count(/μL)
• Serum chemistry(blood urea nitrogen) — Through study completion, an average of 4 years
  Measurement of blood urea nitrogen(mg/dL)
• Serum chemistry(calcium) — Through study completion, an average of 4 years
  Measurement of calcium(mg/dL)
• Serum chemistry(chloride) — Through study completion, an average of 4 years
  Measurement of chloride(mEq/L)
• Serum chemistry(creatinine) — Through study completion, an average of 4 years
  Measurement of creatinine(mg/dL)
• Serum chemistry(total bilirubin) — Through study completion, an average of 4 years
  Measurement of total bilirubin(mg/dL)
• Serum chemistry(direct bilirubin) — Through study completion, an average of 4 years
  Measurement of direct bilirubin(mg/dL)
• Serum chemistry(alkaline phosphatase) — Through study completion, an average of 4 years
  Measurement of alkaline phosphatas（U/L）
• Serum chemistry(alanine aminotransferase) — Through study completion, an average of 4 years
  Measurement of alanine aminotransferase(U/L)
• Serum chemistry(gamma-glutamyl transferase) — Through study completion, an average of 4 years
  Measurement of gamma-glutamyl transferase(U/L)
• Serum chemistry(total protein) — Through study completion, an average of 4 years
  Measurement of total protein(g/dL)
• Serum chemistry(albumin) — Through study completion, an average of 4 years
  Measurement of albumin(g/dL)
• Serum chemistry(globulin) — Through study completion, an average of 4 years
  Measurement of globulin(g/dL)
• Serum chemistry(sodium) — Through study completion, an average of 4 years
  Measurement of sodium(mEq/L)
• Serum chemistry(potassium) — Through study completion, an average of 4 years
  Measurement of potassium(mEq/L)
• Serum chemistry(phosphorus) — Through study completion, an average of 4 years
  Measurement of phosphorus(mq/dL)
• Serum chemistry(glucose) — Through study completion, an average of 4 years
  Measurement of glucose(mq/dL)
• Heart rate — Through study completion, an average of 4 years
  heart rate (beats per minute)
• Respiratory Rate — Through study completion, an average of 4 years
  Respiratory Rate (breaths per minute),
• Blood Pressure — Through study completion, an average of 4 years
  blood pressure, both of systolic and diastolic (mm Hg)
• Electrocardiogram (ECG) Findings — Through study completion, an average of 4 years
  ECG findings, including heart rate (beats per minute), PR Interval (milliseconds), PQ Interval (milliseconds), RR Interval (milliseconds), QRS Interval (milliseconds), and QT Interval (milliseconds), will be recorded.
• Columbia-Suicide Severity Rating Scale (C-SSRS) Scores — Through study completion, an average of 4 years
  Scores on the Columbia-Suicide Severity Rating Scale (C-SSRS) will be recorded. Questions regarding suicide are recorded as yes or no, and the percentage of subject with suicide risk (yes) is assessed.

Trial sites (29)

More Ono Pharmaceutical Co., Ltd. trials in Japan