*EISAI-E2080-G000-303

Study Sponsor: Eisai

Study Title

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

Medicine or Vaccine (generic name)

rufinamide

Sponsor Identification Number

E2080-G000-303

Trial Registry Identification Number(#'s)

NCT01405053
EU CTR 2010-023505-36

Medical Condition

Lennox-Gastaut Syndrome

Phase

Phase 3

Link to study details on the Eisai Clinical Study Register

Link to study details on ClinicalTrials.gov (if available)

https://clinicaltrials.gov/ct2/show/NCT01405053

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2010-023505-36

Datasets and Documents Available for this Study

Additional information about the data and documents available for this study

No restrictions.

Date Added to this Site

November 2017