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NCT00471744: HEAD

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 Spikes

Terminated Phase 3 Last updated 28 January 2009
What this trial tests

Phase 3 trial testing Treatment with levetiracetam or sulthiame over a six-month period. in Epilepsy, Rolandic in 44 participants. Terminated before completion.

Timeline
1 June 2006
1 July 2008

Quick facts

Lead sponsorLudwig-Maximilians - University of Munich
PhasePhase 3
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment44
Start date1 June 2006
Estimated completion1 July 2008
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Ludwig-Maximilians - University of Munich

Who can join

Adults 6 to 12, any sex, with Epilepsy, Rolandic. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Trials by the same sponsor.

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