Efficacy of Keppra for Neonatal Seizures

Sponsor

Stephanie Merhar, MD (Other)

Overall Status

Terminated

CT.gov ID

NCT01475656

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this research study is to learn how well the medication levetiracetam (Keppra) works to treat seizures in full term and premature babies. Levetiracetam is commonly used in babies with seizures at Cincinnati Children's Hospital, especially if the seizures have not been stopped by other medicines. The Food and Drug Administration (FDA) has approved the use of levetiracetam for older children (over the age of 4) but not for infants. Even though it is not FDA approved for this age group, doctors at Cincinnati Children's use the medicine as a second drug in babies whose seizures are not stopped by phenobarbital. Some doctors are concerned that phenobarbital is not the best medicine to treat seizures in babies, so researchers are trying to study other medicines.

In this study, the investigators are looking at how well levetiracetam stops or slows down seizures in babies. The investigators are also studying the blood levels of levetiracetam to learn more about how the medicine is processed by the body and what level of medicine in the body works to stop seizures. The investigators are checking labs before and after giving the dose to make sure the medication does not cause any changes in blood counts, kidney function, or liver function. The investigators are following all of the babies in the study after hospital discharge to see if the parents notice any side effects of the medication. Babies in the study will come back to the High Risk Follow Up Clinic at Cincinnati Children's at 6 months of age for a visit with a neurologist and a neonatologist and developmental testing.

Condition or Disease	Intervention/Treatment	Phase
Neonatal Seizures	Drug: levetiracetam

Study Design

Study Type:

Observational

Actual Enrollment :

2 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Safety, Tolerability, and Efficacy of Levetiracetam for Neonatal Seizures

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Levetiracetam as first line Babies who receive levetiracetam as a first line drug for seizures	Drug: levetiracetam Infants in the both groups will receive 50 mg/kg IV levetiracetam after (continued) seizures are EEG confirmed.
Phenobarbital as first line Babies who receive phenobarbital as a first line drug for seizures and levetiracetam as a second line drug	Drug: levetiracetam Infants in the both groups will receive 50 mg/kg IV levetiracetam after (continued) seizures are EEG confirmed.

Arm

Intervention/Treatment

Levetiracetam as first line

Babies who receive levetiracetam as a first line drug for seizures

Drug: levetiracetam

Infants in the both groups will receive 50 mg/kg IV levetiracetam after (continued) seizures are EEG confirmed.

Phenobarbital as first line

Babies who receive phenobarbital as a first line drug for seizures and levetiracetam as a second line drug

Drug: levetiracetam

Infants in the both groups will receive 50 mg/kg IV levetiracetam after (continued) seizures are EEG confirmed.

Outcome Measures

Primary Outcome Measures

Efficacy [24 hours]
The primary outcome is the proportion of infants who achieve electrographic seizure freedom as measured by continuous EEG monitoring for 24 hours after intravenous levetiracetam administration.

Secondary Outcome Measures

Pharmacokinetics [24 hours]
Pharmacokinetic parameters and the concentration-response relationship will be determined by collecting 3 blood samples in the 24 hours after the dose (2-15 minutes post infusion, 1-2 hours post infusion, and 6-10 hours post infusion).
Safety [7 days]
Safety will be monitored by reviewing changes in vital signs and laboratory parameters after the dose.
Tolerability [6 months]
Infants who remain on levetiracetam after discharge will be followed for 6 months to determine post-hospital treatment-emergent adverse events. All infants in the study will receive a 6 month developmental profile using the Bayley Scales of Infant Development.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 30 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Gestational age ≥ 35 weeks
Postnatal age ≤ 30 days
Birth weight ≥ 2000 grams
Clinical or electrographic seizures of any etiology requiring treatment with an antiepileptic medication (as per the judgment of the clinician caring for the patient)
Parental consent obtained

Exclusion criteria:

Infants with renal insufficiency indicated by serum creatinine > 2.0 (as part of pre-screening, labs obtained as part of routine care will be reviewed. Infants who have not had a creatinine drawn will have one drawn as part of the study after consent is obtained. If the baby requires levetiracetam emergently before the results of the creatinine are back, the dose will still be given and levels will still be drawn as per the protocol.
Infants who have previously received levetiracetam
Parents refuse consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45215

Sponsors and Collaborators

Stephanie Merhar, MD

Investigators

Principal Investigator: Stephanie L Merhar, MD, Children's Hospital Medical Center, Cincinnati

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stephanie Merhar, MD, Assistant Professor of Pediatrics, Children's Hospital Medical Center, Cincinnati

ClinicalTrials.gov Identifier:

NCT01475656

Other Study ID Numbers:

2011-1557

First Posted:

Nov 21, 2011

Last Update Posted:

Apr 19, 2013

Last Verified:

Apr 1, 2013

Additional relevant MeSH terms:

Seizures

Levetiracetam

Study Results

No Results Posted as of Apr 19, 2013