Clinical Trial: 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
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official 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 Les
Brief Summary: This study is designed to evaluate the cognitive effect, safety, and pharmacokinetics (PK) of rufinamide on Lennox-Gastaut Syndrome inadequately controlled in pediatric subjects already taking other anti-epileptic drugs.
Detailed Summary:
Sponsor: Eisai Inc.
Current Primary Outcome: Change in Child Behavior Checklist (CBCL) Total Problems Score [ Time Frame: Baseline to the end of the Treatment Period (=106 weeks) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Time to withdrawal from rufinamide or other AED [ Time Frame: Baseline to the end of the Treatment Period (=106 weeks) ]
- Percent change in total seizure frequency and in frequency by individual type per 28 days [ Time Frame: Baseline to the end of the Treatment Period (=106 weeks) ]
- Worsening of seizures [ Time Frame: Baseline to the end of the Treatment Period (=106 weeks) ]
- Change in CBCL subscores [ Time Frame: Baseline to the end of the Treatment Period (=106 weeks) ]
- Change in Language Development Survey score during Maintenance Period [ Time Frame: Baseline to the end of the Treatment Period (=106 weeks) ]
- Change from Baseline in total and sub-scores of the Quality of Life in Childhood Epilepsy (QoLCE) scale. [ Time Frame: Baseline to the end of the Treatment Period (=106 weeks) ]
Original Secondary Outcome: Same as current
Information By: Eisai Inc.
Dates:
Date Received: July 27, 2011
Date Started: June 2011
Date Completion:
Last Updated: March 21, 2016
Last Verified: February 2016
