SeizuresNCT01261416
Pharmacokinetics of Levetiracetam (Keppra) in Neonates
An observational study of Seizures and Epilepsy, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The primary objective of this study is to determine the pharmacokinetic profile of a loading dose of intravenous levetiracetam, given for clinical reasons, in term and late preterm infants with seizures. Read more about this study
- Who is it for?
- Ages 1 day to 30 days
- What is being tested?
- levetiracetam
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jul 2010
- Phase
- Observational
- 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 1 day to 30 days
- All sexes
- No healthy volunteers
- Child
Study population: Infants ≥ 32 weeks gestation and ≤ 30 days of age requiring treatment with levetiracetam for clinical and/or electrographic seizures or seizure prophylaxis.
Who may be able to join
- Gestational age ≥ 32 weeks
- Postnatal age ≤ 30 days
- Birth weight ≥ 2000 grams
- Admitted to the NICU at Cincinnati Children's Hospital or Good Samaritan Hospital
- Clinical or electrographic seizures of any etiology
- Seizures or seizure prophylaxis requiring treatment with levetiracetam
- Parental consent obtained
Who cannot join
- Infants with renal insufficiency indicated by serum creatinine > 2.0 at any time
- Infants who have previously received levetiracetam
- Parents refuse consent
- Attending physician does not wish the infant to be enrolled in the study
- Infants who are currently receiving an investigational drug
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Pharmacokinetics and Safety of IV Levetiracetam (Keppra) in Full Term and Preterm Neonates
The primary objective of this study is to determine the pharmacokinetic profile of a loading dose of intravenous levetiracetam, given for clinical reasons, in term and late preterm infants with seizures. Secondary objectives are to evaluate the safety and efficacy of levetiracetam in term and preterm infants with seizures.
- Being tested
- levetiracetam
- Keywords
- seizures, epilepsy, neonatal, levetiracetam
- Medical subject headings
- Seizures, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levetiracetamDrug
Patients will receive levetiracetam as needed for clinical and/or electrographic seizures. Need for levetiracetam will be determined by the clinical team and will NOT determined by the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Infants with seizures | Not described Receives: Drug: levetiracetam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic profile
Blood specimens for quantitation of levetiracetam and its metabolite L057 will be obtained from an indwelling vascular catheter not used for study drug infusion or by heel stick in three different sampling schedules:
Group 1 (n=6): at times 2-15 minutes after the end of infusion, 1-2 hours, and 12 hours post start of infusion Group 2 (n=6): at times 2-15 minutes after the end of infusion, 2-4 hours, and 18 hours post start of infusion Group 3 (n=6): at times 2-15 minutes after the end of infusion, 4-8 hours, and 20-24 hours post start of infusion
Measured: 24 hours after dose
Secondary outcomes (2)
Change in vital sign baseline
Short term treatment-emergent adverse effects of levetiracetam will be measured by change from vital sign baseline in the 24 hours after the dose.
Measured: 24 hours
Number of participants with adverse events
Participants' medical records will be reviewed for any adverse effects of the medication seen in the 24 hours after the loading dose.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2010 (estimated)
- Study startOct 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeizuresStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Investigators
- Stephanie Merhar, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261416
- Sponsor's protocol ID
- 101335-2
- Status last verified
- Dec 2010
- First submitted
- 15 Dec 2010
- Last updated
- 16 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Safety of IV Levetiracetam (Keppra) in Full Term and Preterm Neonates
- ClinicalTrials.gov ID
- NCT01261416
- Acronym / sponsor ID
- 101335-2
- Keywords
- seizures, epilepsy, neonatal, levetiracetam
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 16 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to determine the pharmacokinetic profile of a loading dose of intravenous levetiracetam, given for clinical reasons, in term and late preterm infants with seizures. Secondary objectives are to evaluate the safety and efficacy of levetiracetam in term and preterm infants with seizures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants with seizures | – | Drug: levetiracetam |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants ≥ 32 weeks gestation and ≤ 30 days of age requiring treatment with levetiracetam for clinical and/or electrographic seizures or seizure prophylaxis.
Key inclusion criteria (7 listed)
- Gestational age ≥ 32 weeks
- Postnatal age ≤ 30 days
- Birth weight ≥ 2000 grams
- Admitted to the NICU at Cincinnati Children's Hospital or Good Samaritan Hospital
- Clinical or electrographic seizures of any etiology
Key exclusion criteria (5 listed)
- Infants with renal insufficiency indicated by serum creatinine > 2.0 at any time
- Infants who have previously received levetiracetam
- Parents refuse consent
- Attending physician does not wish the infant to be enrolled in the study
- Infants who are currently receiving an investigational drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levetiracetamPatients will receive levetiracetam as needed for clinical and/or electrographic seizures. Need for levetiracetam will be determined by the clinical team and will NOT determined by the study protocol. | Drug | Infants with seizures |
Primary outcome
Pharmacokinetic profile
Time frame: 24 hours after dose
Blood specimens for quantitation of levetiracetam and its metabolite L057 will be obtained from an indwelling vascular catheter not used for study drug infusion or by heel stick in three different sampling schedules: Group 1 (n=6): at times 2-15 minutes after the end of infusion, 1-2 hours, and 12 hours post start of infusion Group 2 (n=6): at times 2-15 minutes after the end of infusion, 2-4 hours, and 18 hours post start of infusion Group 3 (n=6): at times 2-15 minutes after the end of infusion, 4-8 hours, and 20-24 hours post start of infusion
2 secondary outcomes
Change in vital sign baseline
Time frame: 24 hours
Number of participants with adverse events
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Merhar, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Seizures and Epilepsy, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 16 Dec 2010. 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 United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pharmacokinetic profile (time frame: 24 hours after dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2010.