NCT01284530已完成1 期
Evaluation of the Pharmacokinetics, Safety, and Tolerability of TPM XR as Adjunctive Therapy in Pediatric Subjects With Epilepsy
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- steady-state pharmacokinetics (PK) of TPM XR and to assess the safety and tolerability
研究概览
简要总结
Multidose, Open-label, Multi-center Study to examine the steady state pharmacokinetics of TPM XR, as well as, safety and tolerability of repeated oral dosing in pediatric subjects with epilepsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide written IAF, as appropriate, with written informed permission (including ICF where required by regional laws or regulations) from the parent or LAR.
- •Male or female aged 4 to 17 years, inclusive, with a current diagnosis of partial onset or primary generalized epilepsy.
- •Current AED therapy including a stable dose of TPM IR as either adjunctive or monotherapy. All AED therapy (including a Vagal Nerve Stimulator) must have been initiated more than one month prior to Visit 1 and doses must be stable for at least two weeks prior to Visit
- •No diagnosis of a progressive neurological disorder based on previous imaging.
- •Weight within the 25 - 80% weight-for-age percentiles based on the National Center for Health Statistics Growth Charts, and not less than 15.0kg.
- •Able and willing to swallow whole capsules.
- •FOCP should either be sexually inactive for two weeks prior to the first dose and throughout the study or, if sexually active, will be using an effective birth control method.
排除标准
- •A documented history of status epilepticus in the past year or seizures secondary to conditions other than epilepsy.
- •Use of either phenytoin or carbamazepine as current AEDs.
- •Diagnosis or an electroencephalogram consistent with a diagnosis of seizure disorders other than partial onset or primary generalized epilepsy.
- •Current diagnosis of Major Depressive Disorder or any history of suicide intent and/or attempt.
- •History or presence of clinically significant, chronic medical condition which, in the opinion of the Investigator, would preclude the subject from entering the study.
- •History of substance abuse or dependence.
- •Females who are pregnant or lactating.
- •Use of an investigational drug or device or participation in an investigational study within 30 days prior to the first dose of SM.
研究组 & 干预措施
Conversion-25
Experimental
25 mg
干预措施: TPM XR (Drug)
Conversion-50
Experimental
50 mg
干预措施: TPM XR (Drug)
Conversion-100
Experimental
100 mg
干预措施: TPM XR (Drug)
Conversion-200
Experimental
200 mg
干预措施: TPM XR (Drug)
结局指标
主要结局
steady-state pharmacokinetics (PK) of TPM XR and to assess the safety and tolerability
时间窗: 14 days
Relating to repeated oral dosing
次要结局
未报告次要终点
研究者
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