Enteral Levetiracetam For Seizure Control In Pediatric Cerebral Malaria (LVT1)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01660672|
Recruitment Status : Completed
First Posted : August 9, 2012
Results First Posted : October 17, 2014
Last Update Posted : September 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Seizure Epilepsy Cerebral Malaria||Drug: LEVETIRACETAM||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Dose-Escalation, Safety And Feasibility Study Of Enteral Levetiracetam For Seizure Control In Pediatric Cerebral Malaria|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
U.S. FDA Resources
Open label, dose escalation to optimal dose.
liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. If primary outcome is not reached, dose escalation to 150, 225, and 300% standard, as needed, will be conducted.
Other Name: Keppra
- Freedom From Seizure [ Time Frame: 24 hours ]Number of subjects free of seizure at 24 hours after initiation of treatment
- Toxicity Related to LVT [ Time Frame: 1 week ]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.
- Range of Plasma Concentration of LVT Across All Individuals [ Time Frame: 72 hours ]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.
- Number of Participants With Neurologic Sequelae at Discharge [ Time Frame: day 7 ]Number of participants with neurologic sequelae at discharge
- Number of Subjects With Retinopathy at Enrollment [ Time Frame: Upon admission ]Retinopathy status may impact LVT efficacy and subject status will be analyzed based on this characteristic.
- Number of Subjects Exposed to Phenobarbitone Prior to Enrollment [ Time Frame: 0 hour ]Pre-enrollment exposure to phenobarbitone may impact LVT efficacy, and analysis base on this characteristic will be evaluated.
- Number of Participants Requiring AED During Admission [ Time Frame: 7 days ]Number of participants who required AEDS during admission(including for breakthrough seizures in the LVT group) during admission.
- Mean Time to Return to a BCS Score Greater Than or Equal to 4 [ Time Frame: 7 days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01660672
|Queen Elizabeth Central Hospital|
|Blantyre, Malawi, 3|
|Principal Investigator:||Gretchen L Birbeck, M.D.||University of Rochester|