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The study was concluded as planned upon reaching its predetermined endpoint, which included the completion of data collection and achievement of the necessary sample size for statistical significance.
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| Name | Class |
|---|---|
| Xiamen Children's Hospital, Fujian of China | OTHER |
| Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region | OTHER |
| Guangzhou Women and Children's Medical Center | OTHER |
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Current treatments for the brain damaging complication of neonatal seizures are unsatisfactory. A multi-centre Chinese clinical trials with the aim to using oral Levetiracetam to develop new treatment strategies for the treatment of neonatal seizures. The purpose of this study is to determine the correct oral dosing, safety and efficacy for oral Levetiracetam as first line treatment in term new born babies with seizures.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral levetiracetam | Experimental | Oral levetiracetam 50 mg/kg loading dose. 10 mg/kg 8 hourly maintenance |
|
| Intravenous phenobarbital | Active Comparator | Intravenous phenobarbital 20 loading dose (add to 40 mg/kg if seizure discontrol). 5 mg/kg 24 hourly maintenance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral levetiracetam | Drug | Oral load of levetiracetam (50 mg/kg) following identification of EEG confirmed neonatal seizure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| EEG | Efficacy of levetiracetam by assessment of the change from baseline in EEG on Day 15. | At Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Brain Parenchyma Alterations(MRI) | Efficacy of levetiracetam by assessment of the change of brain from baseline in MRI on Day 28. | At Day 28 |
| Neurodevelopment(Bayley Scores) | Efficacy of levetiracetam by assessment of the change from baseline to Day 28 in neurodevelopment via Bayley Scores of Infant Development Mental Development Index (BSID). |
| Measure | Description | Time Frame |
|---|---|---|
| Rate and extent of absorption by assessment of tmax | Comparison of tmax (time to reach maximum plasma concentration) of levetiracetam on Day 1 of each treatment period; up to 6 samples will be collected in each period (i.e. in subjects with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose). | 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) |
Inclusion Criteria:
Neonatal seizure occurred and was proved by EEG according to abnormal discharge of brain. one or more of the following :
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wenhao Zhou, Doctor | Children's Hospital of Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children Hospital of Fudan University | Shanghai | Shanghai Municipality | 201102 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24807683 | Background | Garrity LC, Turner M, Standridge SM. Increased levetiracetam clearance associated with a breakthrough seizure in a pregnant patient receiving once/day extended-release levetiracetam. Pharmacotherapy. 2014 Jul;34(7):e128-32. doi: 10.1002/phar.1439. Epub 2014 May 7. | |
| 24286154 | Background | Bansal S, Blalock D, Kebede T, Dean NP, Carpenter JL. Levetiracetam versus (fos)phenytoin for seizure prophylaxis in pediatric patients with intracranial hemorrhage. J Neurosurg Pediatr. 2014 Feb;13(2):209-15. doi: 10.3171/2013.10.PEDS13256. Epub 2013 Nov 29. |
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| ID | Term |
|---|---|
| D012640 | Seizures |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| D010634 | Phenobarbital |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| Second Affiliated Hospital of Wenzhou Medical University | OTHER |
| Maternal and Child Health Hospital of Hubei Province | OTHER |
| The Maternal & Children Health Hospital of Dehong, Yunnan of China | OTHER |
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| Intravenous phenobarbital | Drug | Intravenous load of phenobarbital (20 mg/kg)following EEG confirmation of seizure activity load. |
|
|
| At Day 28 |
| Seizure Control Days | Efficacy of levetiracetam by assessment of seizure control days. | From Day 1 to Day 28 post-dose in each period |
| Number of Adverse Events（Abnormal Appearance） | This is a composition of general appearance, abdomen, skin, head and neck (including ears, eyes, nose, and throat), lymph nodes, thyroid, musculoskeletal and neurological systems. | From Day 1 to Day 28 post-dose in each period |
| Number of Adverse Events（Abnormal Blood Pressure） | From Day 1 to Day 28 post-dose in each period |
| Number of Adverse Events(Pulse) | From Day 1 to Day 28 post-dose in each period |
| Number of Adverse Events(Respiratory) | From Day 1 to Day 28 post-dose in each period |
| Number of Abnormal Clinical Chemistry | Safety of levetiracetam by assessment of safety laboratory tests. | From Day 1 to Day 28 post-dose in each period |
| Number of Abnormal Hematology | Safety of levetiracetam by assessment of safety laboratory tests. | From Day 1 to Day 28 post-dose in each period |
| Number of Abnormal Clinical Urinalysis | Safety of levetiracetam by assessment of safety laboratory tests. | From Day 1 to Day 28 post-dose in each period |
| Rate and extent of absorption by assessment of Cmax | Comparison of Cmax (maximum observed plasma concentration) of levetiracetam on Day 1 of each treatment period; up to 6 samples will be collected in each period (i.e. in subjects with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose). | 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) |
| Rate and extent of absorption by assessment of AUC(0-4) | Comparison of AUC(0-4) (Area under the plasma concentration-time curve from time zero to 4 hours after administration) of levetiracetam on Day 1 of each treatment period; up to 6 samples will be collected in each period (i.e. in subjects with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose). | 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) |
| Rate and extent of absorption by assessment of Cmax,ss of levetiracetam | Comparison of Cmax,ss (observed maximum plasma concentration at steady state) of levetiracetam on Day 14 of each treatment period; up to 10 samples will be collected in each period (i.e. 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). | 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) |
| Rate and extent of absorption by assessment of AUC(0-24) of levetiracetam | Comparison of AUC(0-24) (Area under the plasma concentration-time curve from time zero to 24 hours after administration) of levetiracetam on Day 14 of each treatment period; up to 10 samples will be collected in each period (i.e. 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). | 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) |
| Rate and extent of absorption by assessment of tmax,ss of levetiracetam | Comparison of tmax,ss (time to reach maximum plasma concentration at steady state) of levetiracetam on Day 14 of each treatment period; up to 10 samples will be collected in each period (i.e. 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). | 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) |
| Rate and extent of absorption by assessment of Cavg,ss of levetiracetam | Comparison of Cavg,ss (average plasma concentration during a dosing interval at steady state) of levetiracetam on Day 14 of each treatment period; up to 10 samples will be collected in each period (i.e. 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). | 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) |
| Rate and extent of absorption by assessment of AUC(0-last) of levetiracetam | Comparison of AUC(0-last) (Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration) of levetiracetam (i.e. in subjects with intensive pharmacokinetic assessments) | 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) |
| Rate and extent of absorption following multiple dose administration by assessment of Cmin of levetiracetam | Comparison of Cmin (predose concentration) of levetiracetam in each treatment period. | At Day 1 and on Day 14 at pre-dose in each period |
| 24231559 | Background | Fang Y, Wu X, Xu L, Tang X, Wang J, Zhu G, Hong Z. Randomized-controlled trials of levetiracetam as an adjunctive therapy in epilepsy of multiple seizure types. J Clin Neurosci. 2014 Jan;21(1):55-62. doi: 10.1016/j.jocn.2013.01.032. Epub 2013 Nov 11. |
| 23921284 | Background | Khan O, Cipriani C, Wright C, Crisp E, Kirmani B. Role of intravenous levetiracetam for acute seizure management in preterm neonates. Pediatr Neurol. 2013 Nov;49(5):340-3. doi: 10.1016/j.pediatrneurol.2013.05.008. Epub 2013 Aug 3. |
| 23425733 | Background | Inaba K, Menaker J, Branco BC, Gooch J, Okoye OT, Herrold J, Scalea TM, Dubose J, Demetriades D. A prospective multicenter comparison of levetiracetam versus phenytoin for early posttraumatic seizure prophylaxis. J Trauma Acute Care Surg. 2013 Mar;74(3):766-71; discussion 771-3. doi: 10.1097/TA.0b013e3182826e84. |
| 23127775 | Background | Kanemura H, Sano F, Sugita K, Aihara M. Effects of levetiracetam on seizure frequency and neuropsychological impairments in children with refractory epilepsy with secondary bilateral synchrony. Seizure. 2013 Jan;22(1):43-7. doi: 10.1016/j.seizure.2012.10.003. Epub 2012 Nov 3. |
| 22990039 | Background | Liu YH, Wang XL, Deng YC, Zhao G. Levetiracetam-associated aggravation of myoclonic seizure in children. Seizure. 2012 Dec;21(10):807-9. doi: 10.1016/j.seizure.2012.08.008. Epub 2012 Sep 16. |
| 22462729 | Background | Jehi LE, Irwin AI, Kayyali H, Vadera S, Bingaman W, Najm I. Levetiracetam may favorably affect seizure outcome after temporal lobectomy. Epilepsia. 2012 Jun;53(6):979-86. doi: 10.1111/j.1528-1167.2012.03453.x. Epub 2012 Mar 29. |
| 22342434 | Background | Steinbaugh LA, Lindsell CJ, Shutter LA, Szaflarski JP. Initial EEG predicts outcomes in a trial of levetiracetam vs. fosphenytoin for seizure prevention. Epilepsy Behav. 2012 Mar;23(3):280-4. doi: 10.1016/j.yebeh.2011.12.005. Epub 2012 Feb 16. |
| 21680209 | Background | Auvin S, Chhun S, Berquin P, Ponchel E, Delanoe C, Chiron C. Aggravation of absence seizure related to levetiracetam. Eur J Paediatr Neurol. 2011 Nov;15(6):508-11. doi: 10.1016/j.ejpn.2011.05.007. Epub 2011 Jun 15. |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001463 | Barbiturates |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |