drugset / Trial / NCT01765218

Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy

NCT01765218 ↗

Phase 1/2 Terminated 34 enrolled Kristin R Hoffman
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The goal is to see whether topiramate (an anti-epileptic agent) improves the outcome of babies with neonatal hypoxic encephalopathy who are receiving whole body cooling.

Timeline

Start
2013-02
Primary completion
2022-01-27
Completion
2022-01-27

Outcome

Outcome not reported

Stopped (Enrollment): “The study was stopped early due to changes in the UC Davis guidelines on who qualified for therapeutic hypothermia and significant difficulty in recruitment of patients following the COVID19 pandemic.”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Topiramate Small molecule 5 mg/kg Other