AzTrials
AzTrials

Neonatal SeizuresPhase 1/2NCT02550028

Levetiracetam Treatment of Neonatal Seizures

A Phase 1/2 study testing Oral levetiracetam and Intravenous phenobarbital in people with Neonatal Seizures, run by Children's Hospital of Fudan University at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages Up to 28 days
Conditions the study is for
Neonatal Seizures
What is being tested?
Oral levetiracetam and Intravenous phenobarbital
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
1 Sep 2015to 1 Jan 2017
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 28 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Neonatal seizure occurred and was proved by EEG according to abnormal discharge of brain. one or more of the following :
  • Male or female term baby with gestational >37 weeks and postnatal age < or= 28 days
  • Birthweight >2500g
  • Written informed consent of parent or guardian

Who cannot join

  • Babies who have been close to death
  • Seizure occurred by metabolic factors (hypoglycemia, hypocalcemia, electrolyte disorder)
  • Babies who have received phenobarbitone or any other anticonvulsive medication before hospitalization
  • Abnormal renal function

Trial locations and contacts

1 site in 1 country.

China1 site

  • Children Hospital of Fudan University

    Shanghai, Shanghai Municipality, 201102

Other trials in China

About this study

Official title: Levetiracetam Treatment of Neonatal Seizures: A Multi-Centre Randomized Blinded Controlled Study of the Efficacy of Oral Levetiracetam as First Line Treatment for Neonatal Seizures in China

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.

Read the detailed description

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.
Being tested
Oral levetiracetam, Intravenous phenobarbital
Keywords
Neonates, Seizure
Medical subject headings
Seizures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral levetiracetamDrug

    Also called Keppra

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

  • Intravenous phenobarbitalDrug

    Also called phenobarbitone

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

Study groups in NCT02550028
Study groupRoleWhat they receive
Oral levetiracetamExperimentalOral levetiracetam 50 mg/kg loading dose. 10 mg/kg 8 hourly maintenance
Receives: Drug: Oral levetiracetam
Intravenous phenobarbitalActive comparatorIntravenous phenobarbital 20 loading dose (add to 40 mg/kg if seizure discontrol). 5 mg/kg 24 hourly maintenance
Receives: Drug: Intravenous phenobarbital

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EEG

    Efficacy of levetiracetam by assessment of the change from baseline in EEG on Day 15.

    Measured: At Day 28

Secondary outcomes (10)

  1. Brain Parenchyma Alterations(MRI)

    Efficacy of levetiracetam by assessment of the change of brain from baseline in MRI on Day 28.

    Measured: At Day 28

  2. 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).

    Measured: At Day 28

  3. Seizure Control Days

    Efficacy of levetiracetam by assessment of seizure control days.

    Measured: From Day 1 to Day 28 post-dose in each period

  4. 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.

    Measured: From Day 1 to Day 28 post-dose in each period

  5. Number of Adverse Events（Abnormal Blood Pressure）

    Measured: From Day 1 to Day 28 post-dose in each period

  6. Number of Adverse Events(Pulse)

    Measured: From Day 1 to Day 28 post-dose in each period

  7. Number of Adverse Events(Respiratory)

    Measured: From Day 1 to Day 28 post-dose in each period

  8. Number of Abnormal Clinical Chemistry

    Safety of levetiracetam by assessment of safety laboratory tests.

    Measured: From Day 1 to Day 28 post-dose in each period

  9. Number of Abnormal Hematology

    Safety of levetiracetam by assessment of safety laboratory tests.

    Measured: From Day 1 to Day 28 post-dose in each period

  10. Number of Abnormal Clinical Urinalysis

    Safety of levetiracetam by assessment of safety laboratory tests.

    Measured: From Day 1 to Day 28 post-dose in each period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2015 (estimated)
  2. Study start1 Sep 2015
  3. Primary completion1 Jan 2017
  4. Study completion1 Jan 2017

Why it stopped: 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02550028
Sponsor's protocol ID
CHFudanU_NNICU3
Status last verified
Dec 2023
First submitted
4 Sep 2015
Last updated
29 Dec 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24807683

  • 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.

    PubMed 24286154

  • 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.

    PubMed 24231559

  • 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.

    PubMed 23921284

  • 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.

    PubMed 23425733

  • 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.

    PubMed 23127775

  • 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.

    PubMed 22990039

  • 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.

    PubMed 22462729

  • 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.

    PubMed 22342434

  • 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.

    PubMed 21680209

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Oral levetiracetam and Intravenous phenobarbital in people with Neonatal Seizures, run by Children's Hospital of Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: 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.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EEG (time frame: At Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02550028, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in