癲癇兒童患者治療

對已完成 EP0034 或 SP848 的癲癇兒童試驗參加者，評估以 2 mg/kg/日至 12 mg/kg/日 給藥長期使用lacosamide口服溶液 Assess the long-term use of lacosamide oral solution dosed at 2mg/kg/day to 12mg/kg/day when administered to pediatric study participants with epilepsy who have completed EP0034 or SP848 study.

糖漿劑

Lacosamide

184

10mg/ml

主要評估指標
1. 治療期間出現之不良事件(TEAEs)發生率
2. 因 TEAE 而退出試驗
3. 因嚴重不良事件(SAEs)而退出試驗
4. 試驗期間之眾數 (modal) 每日劑量
5. 試驗期間之最大每日劑量

Primary End Point
1. Incidence of treatment-emergent adverse events (TEAEs)
2. Withdrawals from study due to TEAEs
3. Withdrawals from study due to Serious Adverse Event (SAEs)
4. Modal daily dose during the study
5. Maximum daily dose during the study

主要納入條件
- 簽署受試者同意書 (Informed Consent Form，ICF) 時，參加者是 ＜6 歲的男性或女性
- 參加者已完成 EP0034 或 SP848 試驗的參與
- 經試驗主持人認定，預期參加者會因參與而獲益

Principal inclusion criteria
- Participant is male or female, aged ＜6 years at the time of signing the Informed Consent Form (ICF)
- Participant has completed participation in EP0034 or SP848
- Participant is expected to benefit from participation, in the opinion of the Investigator

主要排除條件
- 經試驗主持人認定，參加者有可能危害或減損其參與本試驗之能力的醫療或精神狀況。
- 已知參加者對本試驗計畫書所載明之試驗藥物或對照藥物的任何成分過敏
- 參加者正在接受除了 lacosamide (LCM) 以外的任何研究性藥物或使用任何實驗性器材
- 參加者符合 EP0034 或 SP848 試驗的強制退出條件 (亦即「必須」退出的條件)，或者正經歷進行中的嚴重不良事件 (serious adverse event，SAE)
- 經試驗主持人或醫療監測員認定，對任何試驗介入或其部分或藥物的敏感，或是其他的過敏，使得試驗參與成為禁忌

Principal exclusion criteria
- Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant′s ability to participate in this study
- Participant has a known hypersensitivity to any components of the study medication or comparative drugs as stated in this protocol
- Participant is receiving any investigational drugs or using any
experimental devices in addition to lacosamide (LCM)
- Participant meets a mandatory withdrawal criterion (ie, MUST
withdraw criterion) for EP0034 or SP848, or is experiencing an ongoing serious adverse event (SAE)
- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates participation in the study