Levetiracetam Treatment of Neonatal Seizures
关键词
抽象
描述
This project aims to improve the treatment of neonatal seizures. Current treatments are poorly effective and have significant side effects. Levetiracetam has great potential as a treatment for neonatal seizures but is not approved for use in children less than 1 years of age by oral. This study aims to obtain essential data regarding the efficacy and safety of oral Levetiracetam in neonatal population and simultaneously to use EEG monitoring systems that facilitate seizure detection and research.
Specific aims are:
1. To determine the efficacy of oral Levetiracetam in terminating neonatal seizures by EEG in the Neonatal Neurological Intensive Care Unit (NNICU).
2. To determine dose escalation data by studying the additional efficacy of a further dose in non responders.
3. To determine additional pharmacokinetic data to confirm findings from our previous pharmacokinetic study.
4. To determine further safety data of oral Levetiracetam in neonates.
日期
| 最后验证: | 03/31/2019 |
| 首次提交: | 09/03/2015 |
| 提交的预估入学人数: | 09/12/2015 |
| 首次发布: | 09/14/2015 |
| 上次提交的更新: | 04/28/2019 |
| 最近更新发布: | 04/30/2019 |
| 实际学习开始日期: | 08/31/2015 |
| 预计主要完成日期: | 11/30/2019 |
| 预计完成日期: | 11/30/2020 |
状况或疾病
干预/治疗
Drug: Oral levetiracetam
Drug: Intravenous phenobarbital
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Oral levetiracetam Oral levetiracetam 50 mg/kg loading dose. 10 mg/kg 8 hourly maintenance | Drug: Oral levetiracetam Oral load of levetiracetam (50 mg/kg) following identification of EEG confirmed neonatal seizure. |
| Active Comparator: Intravenous phenobarbital Intravenous phenobarbital 20 loading dose (add to 40 mg/kg if seizure discontrol). 5 mg/kg 24 hourly maintenance | Drug: Intravenous phenobarbital Intravenous load of phenobarbital (20 mg/kg)following EEG confirmation of seizure activity load. |
资格标准
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: Neonatal seizure occurred and was proved by EEG according to abnormal discharge of brain. one or more of the following : 1. Male or female term baby with gestational >37 weeks and postnatal age < or= 28 days 2. Birthweight >2500g 3. Written informed consent of parent or guardian Exclusion Criteria: 1. Babies who have been close to death 2. Seizure occurred by metabolic factors (hypoglycemia, hypocalcemia, electrolyte disorder) 3. Babies who have received phenobarbitone or any other anticonvulsive medication before hospitalization 4. Abnormal renal function |
结果
主要结果指标
1. EEG [At Day 28]
次要成果指标
1. Brain Parenchyma Alterations(MRI) [At Day 28]
2. Neurodevelopment(Bayley Scores) [At Day 28]
3. Seizure Control Days [From Day 1 to Day 28 post-dose in each period]
4. Number of Adverse Events（Abnormal Appearance） [From Day 1 to Day 28 post-dose in each period]
5. Number of Adverse Events（Abnormal Blood Pressure） [From Day 1 to Day 28 post-dose in each period]
6. Number of Adverse Events(Pulse) [From Day 1 to Day 28 post-dose in each period]
7. Number of Adverse Events(Respiratory) [From Day 1 to Day 28 post-dose in each period]
8. Number of Abnormal Clinical Chemistry [From Day 1 to Day 28 post-dose in each period]
9. Number of Abnormal Hematology [From Day 1 to Day 28 post-dose in each period]
10. Number of Abnormal Clinical Urinalysis [From Day 1 to Day 28 post-dose in each period]
其他成果措施
1. Rate and extent of absorption by assessment of tmax [At Day 1 in each period (in subjects with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose)]
2. Rate and extent of absorption by assessment of Cmax [At Day 1 in each period (in subjects with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose)]
3. Rate and extent of absorption by assessment of AUC(0-4) [At Day 1 in each period (in subjects with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose)]
4. Rate and extent of absorption by assessment of Cmax,ss of levetiracetam [At Day 14 in each period (in subjects with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)]
5. Rate and extent of absorption by assessment of AUC(0-24) of levetiracetam [At Day 14 in each period (in subjects with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)]
6. Rate and extent of absorption by assessment of tmax,ss of levetiracetam [At Day 14 in each period (in subjects with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)]
7. Rate and extent of absorption by assessment of Cavg,ss of levetiracetam [At Day 14 in each period (in subjects with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)]
8. Rate and extent of absorption by assessment of AUC(0-last) of levetiracetam [At Day 1 and Day 14 in each period (in subjects with intensive pharmacokinetic assessments, on Day 1 at pre-dose and 15 and 30 minutes, and 1, 2 and 4 h post-dose, on Day 14 at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)]
9. Rate and extent of absorption following multiple dose administration by assessment of Cmin of levetiracetam [At Day 1 and on Day 14 at pre-dose in each period]
