CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 44 enrolled
Drug / intervention
Oral Levetiracetam +1 moredrug
Likely dose
Oral Levetiracetam 40 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01982812
NCT01982812Phase 2Completed
CompareCT.gov

A Safety and Feasibility Study of Enteral Levetiracetam vs. Phenobarbital for Seizure Control in Pediatric Cerebral Malaria

University of Rochester·interventional·Posted Nov 13, 2013·Updated Jul 29, 2016

In Brief

A Phase 2 clinical trial evaluating Oral Levetiracetam and Standard AED for Seizure and 2 related conditions. Completed, enrolled 44 participants across 1 site.

Detailed Summary

Pediatric cerebral malaria (CM) affects more than 3 million children each year killing \~20% and leaving one third of survivors with long term neurologic and psychiatric sequelae. Seizures occur commonly with CM and are associated with an increased risk of death and neuropsychiatric disabilities. In this Malawi-based, safety and feasibility study of enteral levetiracetam in pediatric CM, the investigators will lay the groundwork for future efficacy studies aimed at improving seizure control and ultimately decreasing the neurologic morbidity of pediatric CM.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeizure, Epilepsy, Cerebral Malaria
CountriesMalawi
CollaboratorsNational Institute of Neurological Disorders and Stroke (NINDS)

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 13, 2013
Enrollment StartJan 1, 2014
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 12.6 years ago

Interventions

Oral Levetiracetamdrug

liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days

Standard AEDdrug

Active comparitor, Standard AED