Dosing of Levetiracetam (Keppra) in Neonates

NCT01239212 | Completed Phase 1 Results DMC

• 1 other identifier: 101335
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to determine the pharmacokinetic profile of a 50 mg/kg loading dose of intravenous levetiracetam (LEV) in term and late preterm infants with seizures. Secondary objectives are to evaluate the safety and efficacy of a 50 mg/kg loading dose of levetiracetam in term and preterm infants with seizures, and to obtain data on steady state drug levels of levetiracetam in neonates.

Conditions

Seizures

Keywords

seizures; neonate; levetiracetam; Epilepsy; central nervous system diseases; anticonvulsants

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic Profile

  3 levels for levetiracetam and its metabolite L057 will be drawn: at 5-20 minutes after the dose, 1-2 hours after the dose, and 6-10 hours after the dose. In infants who remain on maintenance doses of the medication, a steady state level will be drawn 4-7 days after the loading dose. Outcome reported is clearance. The median maximum clearance rate was measured in each participant and determined by evaluating the levels of levetiracetam at each time point using MW Pharm.

  5-20 minutes after the dose, 1-2 hours after the dose, 6-10 hours after the dose, and possibly 4-7 days after loading dose (if infants remained on maintenance doses)

Interventions

levetiracetam DRUG

50 mg/kg single loading dose of IV levetiracetam

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age ≥ 32 weeks
• Postnatal age ≤ 30 days
• Birth weight ≥ 2000 grams
• Admitted to the Neonatal Intensive Care Unit at Cincinnati Children's Hospital
• Clinical or electrographic seizures of any etiology
• Seizures or seizure prophylaxis requiring treatment with levetiracetam
• Parental consent obtained

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Seizures; Epilepsy; Central Nervous System Diseases

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Stephanie Merhar
• Organization: Cincinnati Children's Hospital Medical Center

stephanie.merhar@cchmc.org

513-636-4200

Study Officials

• Stephanie Merhar, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: November 11, 2010
• Study Start: September 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: September 5, 2021
• Results First Posted: September 8, 2014

Record last verified: 2021-08

Locations

US (1)