Phase 2
N=44
A Safety and Feasibility Study of Enteral LVT vs. Standard of Care for Seizure Control in Pediatric CM
Seizure · Epilepsy · Cerebral Malaria
Bottom Line
View on ClinicalTrials.gov: NCT01982812 ↗Enrolled (actual)
44
Serious AEs
29.5%
Results posted
Jul 2016
Primary outcome: Primary: Minutes With Seizure on EEG — 165.2; 464.8 minutes with seizure
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Oral Levetiracetam (Drug); Standard AED (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Minutes With Seizure on EEG |
165.2; 464.8 | — |
| SECONDARY Required Additional AED |
18; 18 | — |
| SECONDARY Mean Time From Admission to BCS >/= 4 |
35.4; 34.6 | — |
| SECONDARY Sequelae |
19; 14; 3; 2; 1; 5 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01982812). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.