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
NCT01405053, EU CTR 2010-023505-36
Jun 2011 - Oct 2015
Child Behaviour Checklist (CBCL) Total Problems Score at the end of the 2 year treatment period.
Males and females (age 1 to 3 years)
Canada, France, Greece, Italy, Poland, South Africa, United States See moreSee less
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Publication reference citation
Arzimanoglou A, et al. Safety and pharmacokinetic profile of rufinamide in pediatric patients aged less than 4 years with Lennox-Gastaut syndrome: An interim analysis from a multicenter, randomized, active-controlled, open-label study. European Journal of Paediatric Neurology 2016 May 01;20(3):393-402. DOI: 10.1016/j.ejpn.2015.12.015
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Redacted documents are available upon request for this study.