A Multicenter, Open-label, Long-term Extension Study to Investigate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Pediatric Subjects With Epilepsy With Partial-Onset Seizures
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 540
- 试验地点
- 141
- 主要终点
- Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of lacosamide (LCM) in pediatric subjects.
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
- 年龄范围
- 1 Month 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form (ICF) is signed and dated by the subject or legal representative. The ICF or a specific Assent form, where required, will be signed and dated by minors
- •Subject has completed the Transition Period of SP0967 [NCT02477839] or SP0969 [NCT01921205] for the treatment of uncontrolled partial-onset seizures in pediatric epilepsy
- •Subject is expected to benefit from participation, in the opinion of the investigator
- •Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the investigator
- •Subject is male or female aged 1 month to ≤17 years
- •Subject has a diagnosis of epilepsy with partial-onset seizures
排除标准
- •Subject is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM)
- •Subject meets a mandatory withdrawal criterion (ie, MUST withdraw criterion) for SP0967 or SP0969, or is experiencing an ongoing serious adverse event (SAE)
- •For subjects ≥6 years of age, subject has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Visit 1
- •Female subject who is pregnant or nursing, and/or a female subject of childbearing potential who is not surgically sterile or does not practice 1 highly effective method of contraception
研究组 & 干预措施
Lacosamide
In the first week after enrollment into EP0034 subjects will be dosed according to their weight:
- Lacosamide (LCM) 10 mg/kg/day (oral solution) for subjects weighing <30 kg
- LCM 6 mg/kg/day (oral solution) for subjects weighing ≥30 kg to <50 kg
- LCM 300 mg/day (tablets) for subjects weighing ≥50 kg
After 1 week the investigator may adjust the LCM dose during the Treatment Period based on clinical judgment within a range of 2 mg/kg/day to 12 mg/kg/day for the oral solution and 100 mg/day to 600 mg/day for the tablets.
干预措施: Lacosamide (Drug)
结局指标
主要结局
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
时间窗: From Week 0 to the End of Safety Follow-Up (up to Week 104)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose.
Percentage of Participants With Serious TEAEs
时间窗: From Week 0 to the End of Safety Follow-Up (up to Week 104)
A serious adverse event (SAE) must meet 1 or more of the following criteria: • Death, • Life-threatening (Life-threatening does not include a reaction that might have caused death had it occurred in a more severe form.), • Significant or persistent disability/incapacity, • Congenital anomaly/birth defect (including that occurring in a fetus), • Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or participant and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious., • Initial inpatient hospitalization or prolongation of hospitalization. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose.
Percentage of Participants With TEAEs Leading to Study Discontinuation
时间窗: From Week 0 to the End of Safety Follow-Up (up to Week 104)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs leading to study discontinuation. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose.
次要结局
- Percentage of Seizure-free Days During the Study(From Week 0 to End of Treatment (up to Week 96))