Phase 2
N=7
Enteral Levetiracetam For Seizure Control In Pediatric Cerebral Malaria
Seizure · Epilepsy · Cerebral Malaria
Bottom Line
View on ClinicalTrials.gov: NCT01660672 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Freedom From Seizure — 7 individuals
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LEVETIRACETAM (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Freedom From Seizure |
7 | — |
| SECONDARY Toxicity Related to LVT |
— | — |
| SECONDARY Range of Plasma Concentration of LVT Across All Individuals |
35 | — |
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, 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.
Eligibility Criteria
Inclusion Criteria
- Comatose with Blantyre Comas Score ≤ 3
- P. falciparum parasitemia
- Active seizure
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 (NCT01660672). 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.