Epilepsy Clinical Trial
— LVT1Official 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 | 7 |
Est. completion date | July 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Years to 6 Years |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group 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 |
---|---|---|---|---|
Other | Number of Participants With Neurologic Sequelae at Discharge | Number of participants with neurologic sequelae at discharge | day 7 | No |
Other | Number of Subjects With Retinopathy at Enrollment | Retinopathy status may impact LVT efficacy and subject status will be analyzed based on this characteristic. | Upon admission | No |
Other | Number of Subjects Exposed to Phenobarbitone Prior to Enrollment | Pre-enrollment exposure to phenobarbitone may impact LVT efficacy, and analysis base on this characteristic will be evaluated. | 0 hour | No |
Other | Number of Participants Requiring AED During Admission | Number of participants who required AEDS during admission(including for breakthrough seizures in the LVT group) during admission. | 7 days | No |
Other | Mean Time to Return to a BCS Score Greater Than or Equal to 4 | Mean time from admission to a BCS score greater than or equal to 4. The BCS (Blantyre Coma Scale) is a 0-5 scale measuring motor response, verbal response and eye movement assessing the severity of coma in children with cerebral malaria. Lower scores correspond to more profound coma. | 7 days | No |
Primary | Freedom From Seizure | Number of subjects free of seizure at 24 hours after initiation of treatment | 24 hours | No |
Secondary | Toxicity Related to LVT | Toxicity including vomiting, aspiration, complications related to the NGT, laboratory parameters at 24 hours and 1 week post LVT administration, and an overall acute case fatality rate significantly above the consistent historical ward average for CM. Pk studies to evaluate LVT absorption and elimination in pediatric CM. | 1 week | Yes |
Secondary | Range of Plasma Concentration of LVT Across All Individuals | Range of plasma LVT concentrations will be determined through HPLC method at eight timepoints post administration to evaluate LVT absorption and elimination in pediatric CM. | 72 hours | No |
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