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.

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.

Completed
Phase of Trial: Phase III

Latest Information Update: 30 Sep 2017

At a glance

  • Drugs Rufinamide (Primary) ; Antiepileptic drugs
  • Indications Lennox-Gastaut syndrome; Seizures
  • Focus Registrational; Therapeutic Use
  • Acronyms Study 303
  • Sponsors Eisai Inc
  • Most Recent Events

    • 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.
    • 05 Dec 2016 Results published in an Eisai Co Ltd media release.
    • 05 Dec 2016 According to an Eisai media release, results of this study were presented at the 2016 Annual Meeting of the American Epilepsy Society
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