NCT01982812

A Safety and Feasibility Study of Enteral LVT vs. Standard of Care for Seizure Control in Pediatric CM

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 24 Months – 83 Months
• Healthy volunteers: Not accepted

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.

Detailed description

Cerebral malaria (CM) affects \~3 million children each year, primarily in sub-Saharan Africa. Antimalarial medications can rapidly clear P. falciparum parasites, but mortality rates remain high (12-25%). Survivors do not escape unscathed--\~30% experience neurologic sequelae including epilepsy, behavioral disorders and gross neurologic deficits. Acute seizures occur commonly in CM and are associated with higher neurologic morbidity and mortality. Seizure management in malaria endemic regions is challenging because the available antiepileptic drugs (AED) induce respiratory suppression and assisted ventilation is unavailable. More optimal seizure control may improve neurologic outcomes in pediatric CM survivors, especially if the medication used is affordable and can be delivered safely and easily in resource limited settings. The investigators conducted a dose- escalation study detailed elsewhere (NCT01660672) to determine the optimal dose for use in this safety and feasibility study of enteral levetiracetam (LVT) for seizure control in children with CM and seizures admitted to Queen Elizabeth Central Hospital in Blantyre, Malawi. Enteral LVT given via nasogastric tube (NGT) rather than an intravenous (IV) formulation will be used since LVT has excellent enteral bioavailability and IV formations are not affordable in most malaria-endemic regions. LVT 40mg/kg followed by 30mg per kg Q12 hourly. Children admitted with cerebral malaria and seizures will be randomized to LVT vs. standard of care with phenobarbital as needed comparing seizure control, safety, and neurological outcomes.

Conditions

• Seizure
• Epilepsy
• Cerebral Malaria

Interventions

Type	Name	Description
DRUG	Oral Levetiracetam	liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days
DRUG	Standard AED	Active comparitor, Standard AED

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2013-11-13
• Last updated: 2016-07-29
• Results posted: 2016-07-29

Locations

1 site across 1 country: Malawi