MedDataX Logo

Levetiracetam Treatment of Neonatal Seizures

NCT ID: NCT02550028

Last Updated: 2023-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-01

Study Completion Date

2017-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neonatal Seizures

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Neonates Seizure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Oral levetiracetam

Oral levetiracetam 50 mg/kg loading dose. 10 mg/kg 8 hourly maintenance

Group Type EXPERIMENTAL

Oral levetiracetam

Intervention Type DRUG

Oral load of levetiracetam (50 mg/kg) following identification of EEG confirmed neonatal seizure.

Intravenous phenobarbital

Intravenous phenobarbital 20 loading dose (add to 40 mg/kg if seizure discontrol). 5 mg/kg 24 hourly maintenance

Group Type ACTIVE_COMPARATOR

Intravenous phenobarbital

Intervention Type DRUG

Intravenous load of phenobarbital (20 mg/kg)following EEG confirmation of seizure activity load.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oral levetiracetam

Oral load of levetiracetam (50 mg/kg) following identification of EEG confirmed neonatal seizure.

Intervention Type DRUG

Intravenous phenobarbital

Intravenous load of phenobarbital (20 mg/kg)following EEG confirmation of seizure activity load.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Keppra phenobarbitone

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Xiamen Children's Hospital, Fujian of China

OTHER

Sponsor Role collaborator

Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region

OTHER

Sponsor Role collaborator

Guangzhou Women and Children's Medical Center

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role collaborator

Maternal and Child Health Hospital of Hubei Province

OTHER

Sponsor Role collaborator

The Maternal & Children Health Hospital of Dehong, Yunnan of China

OTHER

Sponsor Role collaborator

Children's Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wenhao Zhou, Doctor

Role: STUDY_CHAIR

Children's Hospital of Fudan University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Children Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 24807683 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24286154 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24231559 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23921284 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23425733 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23127775 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22990039 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22462729 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22342434 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21680209 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CHFudanU_NNICU3

Identifier Type: -

Identifier Source: org_study_id

NCT02602015

Identifier Type: -

Identifier Source: nct_alias