Seizures Clinical Trial
Official title:
Phase I/II Study of IV Levetiracetam as an add-on Drug for Seizures in Term Neonates Assessing Pharmacokinetics, Safety and Efficacy.
The purpose of this study is to determine the correct dosing for intravenous levetiracetam in term new born babies with seizures. In addition information on safety and efficacy will be collected. This new anticonvulsant drug is a promising treatment for seizures in newborns.
Status | Completed |
Enrollment | 18 |
Est. completion date | March 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 37 Weeks to 42 Weeks |
Eligibility |
Inclusion Criteria: - Newborns admitted with seizures to the UCSD, Children's Hospital or Sharp Mary Birch NICUs in San Diego, CA, USA as well as Auckland City Hospital, Grafton,Auckland NZ : - Term infants (gestational age greater than or equal to 37 weeks > 2460 grams (max blood for study 6mL =3%) - Postnatal age < 14 days. - Received loading dose of phenobarbital 20mg/kg and/or phenytoin. - Ongoing clinical or electroencephalographic seizures despite this therapy. - For whom parental consent to participate in the study is obtained. Exclusion Criteria: - Serum creatinine greater than 1.2 at enrollment or greater than 2.0 at any time. - Biochemical abnormality - hypoglycemia, hypocalcemia- that when treated result in seizure cessation. - Severe hypoxic ischemic injury likely to result in imminent death |
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
New Zealand | Auckland City Hospital | Auckland | |
United States | Sharpe Mary Birch Hospital | San Diego | California |
United States | UCSD Hillcrest Medical Center | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Richard H. Haas | Pediatric Pharmacology Research Units Network, Thrasher Research Fund |
United States, New Zealand,
Sharpe CM, Capparelli EV, Mower A, Farrell MJ, Soldin SJ, Haas RH. A seven-day study of the pharmacokinetics of intravenous levetiracetam in neonates: marked changes in pharmacokinetics occur during the first week of life. Pediatr Res. 2012 Jul;72(1):43-9 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacokinetic data on intravenous levetiracetam administered to term neonates over 7 days. | Study completion | No | |
Secondary | Preliminary safety data and efficacy data will be collected. | Study completion | Yes |
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