drugset / Trial / NCT00830531
Pilot Study of Bumetanide for Newborn Seizures
Phase 1
Completed
43 enrolled
Soul, Janet , M.D.
Boston Children's Hospital · collabCharles H. Hood Foundation · collabCitizens United for Research in Epilepsy · collabHarvard Catalyst- Harvard Clinical and Translational Science Center · collabNational Institute of Neurological Disorders and Stroke (NINDS) · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The main goal of the study is to obtain pharmacokinetic and safety data of bumetanide in newborns with refractory seizures. The overall hypothesis is that bumetanide, added to conventional antiepileptic (antiseizure) medications, will be a safe and well tolerated medication, compared with conventional antiepileptic drugs alone.
Timeline
- Start
- 2010-01
- Primary completion
- 2019-01
- Completion
- 2019-01
Publications
- Background Dzhala VI, Talos DM, Sdrulla DA, Brumback AC, Mathews GC, Benke TA, Delpire E, Jensen FE, Staley KJ. NKCC1 transporter facilitates seizures in the developing brain. Nat Med. 2005 Nov;11(11):1205-13. doi: 10.1038/nm1301. Epub 2005 Oct 9.
- Background Dzhala VI, Brumback AC, Staley KJ. Bumetanide enhances phenobarbital efficacy in a neonatal seizure model. Ann Neurol. 2008 Feb;63(2):222-35. doi: 10.1002/ana.21229.
- Background Li Y, Cleary R, Kellogg M, Soul JS, Berry GT, Jensen FE. Sensitive isotope dilution liquid chromatography/tandem mass spectrometry method for quantitative analysis of bumetanide in serum and brain tissue. J Chromatogr B Analyt Technol Biomed Life Sci. 2011 Apr 15;879(13-14):998-1002. doi: 10.1016/j.jchromb.2011.02.018. Epub 2011 Feb 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bumetanide | Small molecule | 0.1 mg/kg | Intravenous |
| Subject | Bumetanide | Small molecule | 0.2 mg/kg | Intravenous |
| Subject | Bumetanide | Small molecule | 0.3 mg/kg | Intravenous |