Enteral Levetiracetam for Seizure Control in Pediatric Cerebral Malaria (LVT1)

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Description:

The purpose of this trial is to determine the safety and feasibility of levetiracetam (LVT) to control seizures in children with cerebral malaria.

Cerebral malaria is a severe form of malaria that affects the brain and occurs predominantly in children.  It affects about 3 million children every year, primarily in sub-Saharan Africa, and has a mortality rate of 15-25 percent.  Seizure management in malaria-prone regions such as sub-Saharan Africa is challenging because the available antiepileptic drugs can suppress respiration and assisted ventilation is not available.  LVT, however, does not have that effect.  Researchers in this study hope to optimize a seizure control treatment that is both affordable and accessible in resource-limited settings, such as Malawi, and to ultimately improve neurological outcomes for cerebral malaria survivors.

This Malawi-based, dose-escalation study will test the safety and feasibility of LVT to control seizures in children with cerebral malaria.  About 40 children will be selected for the trial.  Participants will be given LVT via a tube in the nasal passage instead of intravenously, which is too costly for most  low income nations such as Malawi.  If all safety standards are met, dosage will be increased until 75 percent of children are free of seizures for 24 hours.  Typically, only 20 percent of children admitted with cerebral malaria and seizures are seizure-free in the first 24 hours.

To accurately determine if the children are seizure-free, researchers will use portable, wireless electroencephalogram (EEG) monitoring devices called microEEGs.  These devices feature small monitors that can be worn on the children’s arms, with wires connecting to electrodes placed on the children’s heads.  The monitors then transfer real-time data to a computer via wireless technology, where it quickly can be analyzed and shared.

If the trial shows that LVT is safe and effective for controlling acute symptomatic seizures in cerebral malaria, the researchers will proceed with a phase III clinical trial for further study. Phase III would include long term (24-36 months post cerebral malaria recovery) neurologic outcomes as the primary outcome of interest.

Phase: 

Eligibility Criteria:

Inclusion:

• Comatose with Blantyre Comas Score ≤ 2
• P. falciparum parasitemia
• Active seizure in 24 hours prior to evaluation

Exclusion:

• 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

Study Design: 

Study Locations: 

For more information:

Contact:  Gretchen Birbeck, M.D. +1-517-884-0277 or +265-995-008069 gretchen.birbeck@ht.msu.edu;

Visit:  http://clinicaltrials.gov/ct2/show/NCT01660672

Last Reviewed November 9, 2012