A controlled clinical trial to look at the effects of treatment with rufinamide on the body, thought process development and its safety in children aged 1 to 4 years with poorly controlled Lennox Gastaut Syndrome.

Registry ID
EUCTR2010-023505-36
Source registry
EUCTR
Phase
PHASE3
Sponsor
Eisai Ltd
Start date
2011-07-11
Last update
2026-08-16

Conditions

Summary

To compare the effect of 2 drug regimens consisting of either rufinamide or any other approved AED of the investigator’s choice as an add-on to the subject’s existing regimen of 1-3 AEDs on the overall safety and tolerability of rufinamide in subjects aged 1 to less than 4 years of age with inadequately controlled LGS To characterize the age group specific pharmacokinetics of rufinamide in a pediatric population, 1 to less than 4 years of age, with inadequately controlled LGS, using the population approach To evaluate the effect of rufinamide as adjunctive treatment on the cognitive development and behavioral effects in a pediatric population, 1 to less than 4 years of age, with inadequately controlled LGS.

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