Trial Profile
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
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 07 Aug 2019
Price :
$35
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At a glance
- Drugs Rufinamide (Primary) ; Antiepileptic drugs
- Indications Lennox-Gastaut syndrome
- Focus Registrational; Therapeutic Use
- Acronyms Study 303
- Sponsors Eisai Inc
- 27 Apr 2018 Results of a post hoc analysis, presented at the 70th Annual Meeting of the American Academy of Neurology
- 27 Apr 2018 Results from NCT01151540, NCT01405053, NCT01146951 and 2 other studies, presented at the 70th Annual Meeting of the American Academy of Neurology
- 05 Dec 2016 Primary endpoint has not been met. (Change in Child Behavior Checklist (CBCL) Total Problems Score), as reported in an Eisai Co Ltd media release.