Evaluation of the safety and cognitive effects of rufinamide in pediatric patients

Description:
Lennox-Gastaut Syndrome (LGS) is a severe form of epilepsy that is characterized by frequent seizures, different seizure types and difficulty controlling those seizures. Currently this is no cure for LGS and therapy is aimed at controlling seizures, often requiring several medications. This study is meant to evaluate the safety of rufinamide in pediatric patients (1-4 years) with LGS that is currently not adequately controlled

Medication Under Study:
Rufinamide

Full study title:
A Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to less than 4 years of age with Inadequately Controlled Lennox-Gastaut Syndrome

IRB Study ID:
110709


Who may qualify:

Children ages 1-4 years old with Lennox-Gastaut Syndrome

Who does not qualify:

Patients under 1 year or over 4 years old or unable to tolerate rufinamide

If you are interested in this study or have questions about your child's eligibility, please contact:

Rebecca D. Considine Research Institute, 330-543-5012

For urgent patient care matters involving a current study patient, please call: 330-920-5774


Lead Principal Investigator:

Photo
Thomas Enlow, MD
Pediatric Neurologist


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