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临床试验/NCT06590896
NCT06590896招募中2 期

A Phase 2, Multicenter Open-Label Extension Study to Evaluate the Long-term Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures

Ono Pharmaceutical Co. Ltd29 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年11月4日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (29)

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