Epilepsy Clinical Trial
Official title:
A Dose-Escalation, Safety and Feasibility Study of Enteral Levetiracetam for Seizure Control in Pediatric Cerebral Malaria
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, dose- escalation, 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.
Status | Completed |
Enrollment | 44 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 24 Months to 83 Months |
Eligibility |
Inclusion Criteria: - Comatose with Blantyre Comas Score = 2 - P. falciparum parasitemia via thick blood film or rapid diagnostic test - Active seizure in past 24 hours Exclusion Criteria: - Serum creatinine > 2mg/dL - Pre-admission/concomitant treatment with antiretroviral medications for HIV (ARVs), antituberculous treatments(ATTs), or chronic use of any other enzyme-inducing medications |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Malawi | Queen Elizabeth Central Hospital | Blantyre |
Lead Sponsor | Collaborator |
---|---|
University of Rochester | National Institute of Neurological Disorders and Stroke (NINDS) |
Malawi,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Minutes with seizure on EEG | Comparing LVT to standard AED the number of minutes spent in seizure per cEEG in the 72 hours after treatment allocation. | 72 hours | No |
Secondary | The AEDs required during admission | The AEDs required (including for breakthrough seizures in LVT group) during admission includ-ing agent(s) and overall quantity received | 7 days | No |
Secondary | Mean time from admission to BCS >/= 4 | The mean time from admission to the subject reaches Blantyre Coma Scale of greater than or equal to 4 | 7 days | No |
Secondary | Sequelae | Neurologic sequelae at discharge | 7 days | Yes |
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