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Trial record 5 of 237 for:    LEVETIRACETAM

Efficacy of Levetiracetam in Control of Neonatal Seizures Guided by an EEG

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ClinicalTrials.gov Identifier: NCT03107507
Recruitment Status : Unknown
Verified March 2017 by Yara Salah Shaheen, Cairo University.
Recruitment status was:  Recruiting
First Posted : April 11, 2017
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
Yara Salah Shaheen, Cairo University

Brief Summary:

Over the last three decades, several tools have been developed to enhance the detection and treatment of neonatal seizures. Regarding treatment, phenobarbital maintains is still used as a first-line therapy worldwide. However, newer anti-epileptic drugs (AED) s such as, levetiracetam, bumetanide, and topiramate are increasingly being applied to the neonatal population, offering the potential for seizure treatment with a significantly better side-effect profile.

Levetiracetam is a very promising medication for the treatment of neonatal seizures. It has been in clinical use for almost a decade in adults and older children with good efficacy, an excellent safety profile and near ideal pharmacokinetic characteristics. It has been approved and used for treatment of seizures in infants starting one month of age since 2012.

The investigators are comparing the efficacy of levetiracetam to that of phenobarbital as a first-line drug in control of neonatal seizures. The investigators monitor the efficacy through assessment of frequency of seizures before and after drug administration, amplitude integrated EEG changes in background activity and seizure frequency in participants, duration taken for participants to be seizure free and short term neurodevelopmental outcome and EEG at 3 months of age


Condition or disease Intervention/treatment Phase
Neonatal Seizures Drug: Levetiracetam Drug: Phenobarbital Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Levetiracetam in Control of Neonatal Seizures
Actual Study Start Date : March 25, 2017
Estimated Primary Completion Date : October 30, 2017
Estimated Study Completion Date : December 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Arm Intervention/treatment
Active Comparator: Levetiracetam

Levetiracetam given in oral form via oro-gastric tube, first a bolus dose 40-50mg/kg then maintenance dose 10-30 mg/kg/day divided every 12 hours.

Duration: until seizure free

Drug: Levetiracetam
Given in a bolus dose first 50mg/kg as levetiracetam reaches a therapeutic serum level rapidly in 1.3 hours. Titration will not be attempted in our study to reach drug level rapidly and consequent rapid effective control of seizures. Maintenance dose is then given at a dose of 10 - 40mg/kg/day divided every 12 hours.

Active Comparator: Phenobarbital

Phenobarbital given in IV form, loading dose 20mg/kg that can be repeated after a 20 minute interval not to exceed 40mg/kg then maintenance dose 2-4 mg/kg/day divided every 12 hours.

Duration: until seizure free

Drug: Phenobarbital
Phenobarbital is given intravenously in the form of a loading dose of 15mg/kg that can be repeated after a 20 minute interval not to exceed 30mg/kg then a maintenance dose 2-4 mg/kg/day divided every 12 hours.




Primary Outcome Measures :
  1. Efficacy of levetiracetam in control of neonatal seizures as a first line versus phenobarbital through assessment of seizure burden. [ Time Frame: 72 hours ]
    Number of seizures before and after levetiracetam administration in comparison to phenobarbital.

  2. Efficacy of levetiracetam in rapid control of neonatal seizures compared to phenobarbital. [ Time Frame: 72 hours ]
    Number of hours taken to achieve seizure freedom after administration of levetiracetam versus phenobarbital.


Secondary Outcome Measures :
  1. Dose escalation data about levetiracetam through studying the efficacy of further dose administration in non responders. [ Time Frame: 72 hours ]
    Number of originally non responder participants who achieved seizure control with higher doses of levetiracetam.

  2. Adequacy of levetiracetam as a single agent antiepileptic drug in control of neonatal seizures. [ Time Frame: 30 days ]
    Number of participants who require addition of second line antiepileptic drug to control seizures after levetiracetam versus phenobarbital use.

  3. Accuracy of amplitude integrated EEG monitoring in detecting neonatal seizures before and after antiepileptic drug use. [ Time Frame: 48 hours ]
    Number of seizures detected by aEEG before and after antiepileptic drug use.

  4. Effect of levetiracetam on aEEG background activity of participants. [ Time Frame: 48 hours ]
    Number of participants with normalization of background activity after administration of levetiracetam versus phenobarbital.

  5. The short term clinical outcome of patients with neonatal seizures after treatment with levetiracetam. [ Time Frame: 3 months ]

    Neurodevelopmental assessment through detecting presence of following milestones:

    1. Head control
    2. Social smile
    3. Visual fixation and pursuit
    4. Turning towards sounds

  6. The short term electroencephalographic outcome of patients with neonatal seizures after treatment with levetiracetam [ Time Frame: 3 months ]
    Number of participants with presence of epileptogenic activity on follow up electroencephalogram.


Other Outcome Measures:
  1. To gather safety information on levetiracetam use in neonates [ Time Frame: 72 hours ]
    By collecting data of renal and liver function tests 48-72 hours after treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All full term neonates experiencing seizures due to; post-hypoxic or post-ischemic encephalopathy, intracerebral hemorrhage, cerebral infection, inborn errors of metabolism or malformations of cortical development

Exclusion Criteria:

  • Preterm neonates
  • Full term neonates with seizures due to metabolic derangements (hypoglycemia, hypocalcemia or hypomagnesemia)
  • Full term neonates with impaired renal functions.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03107507


Contacts
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Contact: Yara S Shaheen, Msc 01227981313 ext 002 yarasalah.shaheen@gmail.com
Contact: Aliaa A Ali, MD draliaaadel@yahoo.com

Locations
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Egypt
Cairo University Children's Hospital (Abulreesh) Recruiting
Cairo Governorate, Egypt
Contact: Yara Shaheen         
Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: Omneya G Afify, MD Cairo University
Study Director: Iman F Iskander, MD Cairo University
Principal Investigator: Aliaa A Ali, MD Cairo University
Principal Investigator: Yara S Shaheen, MSc. Cairo University
Principal Investigator: Walaa Shaarany, MD Cairo University

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Responsible Party: Yara Salah Shaheen, Pricipal Investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03107507     History of Changes
Other Study ID Numbers: YSShaheen
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: March 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Yara Salah Shaheen, Cairo University:
EEG with Periodic Abnormalities
Levetiracetam
Phenobarbitone
neonatal seizures
Neurodevelopmental Abnormality
Additional relevant MeSH terms:
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Levetiracetam
Seizures
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Phenobarbital
Anticonvulsants
Nootropic Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
GABA Agents
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers