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, United States See moreSee less
The CSR synopses contained on this website are from clinical trials sponsored by Eisai and are provided for informational purposes only. These summaries contain data from the specific study population but do not include the patient-level data from each study participant. The results reported in any single trial may not reflect the overall potential risks or benefits associated with Eisai’s products.
Only health care professionals may determine if a specific product is appropriate as a treatment option for a particular patient. Health care professionals should refer to the specific labelling information approved in their country when making prescribing decisions.
The information provided is not intended to commercialize or promote Eisai’s products for any unapproved uses.
All reasonable precautions have been taken to ensure the accuracy, security and confidentiality of information contained on this website. Eisai reserves the right to amend any information on this website at any time at its sole discretion.
No download available
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
ClinicalStudyDataRequest.com (CSDR) is a multi sponsor site through which qualified researchers who wish to access clinical trial data and associated information in order to conduct further research can submit their research proposal or enquiry.
Redacted documents are available upon request for this study.