A Phase 2, Multicenter Open-Label Extension Study to Evaluate the Long-term Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 29
- 主要终点
- Incidences of Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
To evaluate the long-term safety and tolerability of cenobamate in Japanese epilepsy patients with partial seizures
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects completed Study YKP3089C035 by SK Life Science.
排除标准
- •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.
研究组 & 干预措施
Cenobamate
干预措施: Cenobamate (Drug)
结局指标
主要结局
Incidences of Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Through study completion, an average of 4 years
The incidences of adverse events (AEs) and serious adverse events (SAEs) will be recorded.
Urinalysis(pH)
时间窗: Through study completion, an average of 4 years
Measurement of urine pH.
Urinalysis(Specific Gravity)
时间窗: Through study completion, an average of 4 years
Measurement of urine specific gravity (g/mL).
Urinalysis(Protein)
时间窗: Through study completion, an average of 4 years
Measurement of urine protein (mg/dL).
Urinalysis(Glucose)
时间窗: Through study completion, an average of 4 years
Measurement of urine glucose (mg/dL).
Urinalysis(Ketone)
时间窗: Through study completion, an average of 4 years
Measurement of urine ketone (mg/dL).
Urinalysis(Bilirubin)
时间窗: Through study completion, an average of 4 years
Measurement of urine bilirubin (mg/dL).
Urinalysis(Blood)
时间窗: Through study completion, an average of 4 years
Measurement of urine blood (presence/absence).
Urinalysis(Nitrite)
时间窗: Through study completion, an average of 4 years
Measurement of urine nitrite (presence/absence).
Urinalysis(Urobilinogen)
时间窗: Through study completion, an average of 4 years
Measurement of urine urobilinogen (mg/dL).
Urinalysis( Microscopic Examination)
时间窗: Through study completion, an average of 4 years
Microscopic examination of urine (if abnormal).
Liver function tests(total protein)
时间窗: Through study completion, an average of 4 years
Measurement of total protein(g/dL)
Liver function tests(albumin)
时间窗: Through study completion, an average of 4 years
Measurement of albumin(g/dL)
Liver function tests(total bilirubin)
时间窗: Through study completion, an average of 4 years
Measurement of total bilirubin(mg/dL)
Liver function tests(aspartate transaminase)
时间窗: Through study completion, an average of 4 years
Measurement of aspartate transaminase(U/L)
Liver function tests(alanine aminotransferase)
时间窗: Through study completion, an average of 4 years
Measurement of alanine aminotransferase(U/L)
Liver function tests(alkaline phosphatase)
时间窗: Through study completion, an average of 4 years
alkaline phosphatase(U/L)
Liver function tests(gamma-glutamyl transferase)
时间窗: Through study completion, an average of 4 years
Measurement of gamma-glutamyl transferase(U/L)
Hematology(Hemoglobin)
时间窗: Through study completion, an average of 4 years
Measurement of hemoglobin(g/dL)
Hematology(hematocrit)
时间窗: Through study completion, an average of 4 years
Measurement of hematocrit(%)
Hematology(white blood cell count)
时间窗: Through study completion, an average of 4 years
Measurement of white blood cell count(/μL)
Hematology(red blood cell count)
时间窗: Through study completion, an average of 4 years
Measurement of red blood cell count(/μL)
Hematology(mean corpuscular volume)
时间窗: Through study completion, an average of 4 years
Measurement of mean corpuscular volume(fL)
Hematology(mean corpuscular hemoglobin)
时间窗: Through study completion, an average of 4 years
Measurement of mean corpuscular hemoglobin(pg)
Hematology(red blood cell distribution width)
时间窗: Through study completion, an average of 4 years
Measurement of red blood cell distribution width(%)
Hematology(platelet count)
时间窗: Through study completion, an average of 4 years
Measurement of platelet count(/μL)
Serum chemistry(blood urea nitrogen)
时间窗: Through study completion, an average of 4 years
Measurement of blood urea nitrogen(mg/dL)
Serum chemistry(calcium)
时间窗: Through study completion, an average of 4 years
Measurement of calcium(mg/dL)
Serum chemistry(chloride)
时间窗: Through study completion, an average of 4 years
Measurement of chloride(mEq/L)
Serum chemistry(creatinine)
时间窗: Through study completion, an average of 4 years
Measurement of creatinine(mg/dL)
Serum chemistry(total bilirubin)
时间窗: Through study completion, an average of 4 years
Measurement of total bilirubin(mg/dL)
Serum chemistry(direct bilirubin)
时间窗: Through study completion, an average of 4 years
Measurement of direct bilirubin(mg/dL)
Serum chemistry(alkaline phosphatase)
时间窗: Through study completion, an average of 4 years
Measurement of alkaline phosphatas(U/L)
Serum chemistry(alanine aminotransferase)
时间窗: Through study completion, an average of 4 years
Measurement of alanine aminotransferase(U/L)
Serum chemistry(gamma-glutamyl transferase)
时间窗: Through study completion, an average of 4 years
Measurement of gamma-glutamyl transferase(U/L)
Serum chemistry(total protein)
时间窗: Through study completion, an average of 4 years
Measurement of total protein(g/dL)
Serum chemistry(albumin)
时间窗: Through study completion, an average of 4 years
Measurement of albumin(g/dL)
Serum chemistry(globulin)
时间窗: Through study completion, an average of 4 years
Measurement of globulin(g/dL)
Serum chemistry(sodium)
时间窗: Through study completion, an average of 4 years
Measurement of sodium(mEq/L)
Serum chemistry(potassium)
时间窗: Through study completion, an average of 4 years
Measurement of potassium(mEq/L)
Serum chemistry(phosphorus)
时间窗: Through study completion, an average of 4 years
Measurement of phosphorus(mq/dL)
Serum chemistry(glucose)
时间窗: Through study completion, an average of 4 years
Measurement of glucose(mq/dL)
Heart rate
时间窗: Through study completion, an average of 4 years
heart rate (beats per minute)
Respiratory Rate
时间窗: Through study completion, an average of 4 years
Respiratory Rate (breaths per minute),
Blood Pressure
时间窗: Through study completion, an average of 4 years
blood pressure, both of systolic and diastolic (mm Hg)
Electrocardiogram (ECG) Findings
时间窗: 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
时间窗: 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.
次要结局
- Percentage Change in all partial seizure frequency per 28-Day(Through study completion, an average of 4 years)
