Study of Rufinamide in Pediatric Subjects 1 to Less Than 4 Years of Age With Lennox-Gastaut Syndrome Inadequately Controlled With Other Anti-epileptic Drugs

Completed · Phase 3

Conditions studied: Lennox-Gastaut Syndrome

In brief

This study was designed to evaluate the cognitive effect, safety, and pharmacokinetics (PK) of rufinamide on Lennox-Gastaut Syndrome (LGS) inadequately controlled in pediatric participants already taking other anti-epileptic drugs.

Key facts

Study ID

NCT01405053

Run by

Eisai Inc.

People needed

37

Starts

2011-06-16

Expected to finish

2015-11-02

Last updated by the study team

2019-08-06

Who can join

Age: 1 and older, up to 3. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Study site — San Diego, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Gulf Breeze, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Wellington, Florida, United States
• Study site — Augusta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Lexington, Kentucky, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Lebanon, New Hampshire, United States
• Study site — Gibbsboro, New Jersey, United States
• Study site — Rochester, New York, United States
• Study site — Akron, Ohio, United States
• Study site — Akson, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Austin, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Norfolk, Virginia, United States
• Study site — Calgary, Alberta, Canada
• Study site — Edmonton, Alberta, Canada
• Study site — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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