An Open-Label, Uncontrolled, Long-Term Study to Assess the Safety of LAMICTAL in Pediatric Subjects Previously Enrolled in Protocol LAM20006 and In LAMICTAL-naive Subjects (1-24 Months of Age)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 197
- 试验地点
- 71
- 主要终点
- Change from baseline in vital signs -heart rate (HR)
研究概览
简要总结
This study will evaluate the long-term safety of LAMICTAL(lamotrigine)in subjects with partial seizures previously enrolled in protocol LAM20006 and in subjects 1-24 months of age who have never received LAMICTAL(LAMICTAL-naive). For LAMICTAL-naive subjects, LAMICTAL will be added to the subject's current epilepsy medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have completed the Open-Label Phase of protocol LAM20006 or meet criteria for LAMICTAL naive subjects as follows:
- •A confident diagnosis of epilepsy.
- •4 or more partial seizures per month.
- •current treatment with 1 or 2 anti-epileptic drugs.
排除标准
- •Has seizures not related to epilepsy.
- •Has a surgically implanted and functioning vagal nerve stimulator.
- •Has previously been treated with lamotrigine.
- •Is currently taking felbamate, ACTH (adrenocorticotrophic hormone) or is on the ketogenic diet.
- •Use of experimental medication within 30 days of enrollment.
结局指标
主要结局
Change from baseline in vital signs -heart rate (HR)
时间窗: Up to 43 Months
Change from baseline in vital signs - weight (WT)
时间窗: Up to 43 months
Number of participants with overall, serious, drug-related treatment emergent adverse events and adverse events leading to premature study discontinuation
时间窗: 43 Months
Change from baseline in clinical chemistry parameters including Albumin and Total protein
时间窗: Up to month 43
Change from baseline in Hemoglobin (Hb)
时间窗: Up to 43 months
Change from baseline in mean corpuscular volume (MCv)
时间窗: Up to 43 months
Change from baseline in red blood cells (RBC)
时间窗: Up to 43 months
Change from baseline in clinical chemistry parameters including total bilirubin and creatinine
时间窗: Up to 43 months
Change from baseline in clinical chemistry parameters including glucose (glu), potassium (K), sodium (Na) and urea
时间窗: Up to 43 months
Change from baseline in Mean corpuscular hemoglobin (MCH)
时间窗: Up to 43 months
Number of participants with treatment emergent clinically significant ECG abnormalities
时间窗: Up to 43 months
Change from baseline in clinical chemistry parameters including alkaline phosphatase, Alanine transaminase (ALT), and Aspartate Aminotransferase (AST)
时间窗: Up to 43 moths
Change from baseline in vital signs - height (HT)
时间窗: Up to 43 months
Change from baseline in vital signs - head circumference (HC)
时间窗: Up to 43 months
Change from baseline in Mean corpuscular hemoglobin concentration (MCHC)
时间窗: Up to 43 months
Number of participants with treatment emergent neurological abnormalities
时间窗: Up to 43 months
Number of participants with potentially clinically significant change in vital signs
时间窗: Up to 43 months
Change from baseline in hematological parameters including bands, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and total white blood cells (WBC)
时间窗: Up to 43 moths
Number of participants with potentially clinically significant change in clinical chemistry parameters
时间窗: Up to 43 months
Number of participants with potentially clinically significant change in hematology parameters
时间窗: Up to 43 months
次要结局
- Mean Maximal plasma concentration (Cmax) in serum and saliva of Lamicital -naïve participants(Week 6)
- Mean percentage change in seizure frequency between the Historical Baseline Phase and over the course of the 48-week Treatment Phase(Up to 48 Weeks)
- Investigator's assessment of the participant's overall clinical status(Up to 43 months)