Clinical Trial: HEAD-Study Optimizing the Treatment of Children With BECTS
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: HEAD-TO-HEAD Evaluation of the Antiepileptic Drugs Levetiracetam (LEV) vs. Sulthiame (STM) in a German Multi-Centre, Doubleblind Controlled Trial in Children With Benign Epilepsy With Centro-Temporal
Brief Summary: The investigators hypothesize that Levetiracetam is as effective as Sulthiame in the treatment of children with BECTS. Patients entering the HEAD-Studie are either treated with Leveitracetam or Sulthiame over a 6 months period. Patients are equally randomised to one of the two treatment regimens. Administration of medication as blinded capsules.
Detailed Summary:
Sponsor: Ludwig-Maximilians - University of Munich
Current Primary Outcome: To evaluate the efficacy of levetiracetam in the treatment of children with BECTS compared to sulthiame [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Safety and tolerability [ Time Frame: 6 months ]
- Cognitive effects [ Time Frame: 6 months ]
- Efficacy on EEG pattern [ Time Frame: 6 months ]
Original Secondary Outcome: Same as current
Information By: Ludwig-Maximilians - University of Munich
Dates:
Date Received: May 8, 2007
Date Started: June 2006
Date Completion:
Last Updated: January 28, 2009
Last Verified: January 2009
