TerminatedPhase 3

HEAD-Study Optimizing the Treatment of Children With BECTS

Stopped: low patient number after 2 years recruiting

Germany44 participantsStarted 2006-06

Plain-language 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.

Who can participate

Age range

6 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age between 6 and 12 years
. Weight between 15 kg and 60 kg
. At least two preceding seizures within the last six months before study start
. Typical electroencephalogram (EEG) with Rolando focus (centrotemporal spike or sharp-wave-focus)
. Diagnosis of BECTS
. Written informed consent from parents and child

Exclusion criteria

. Other forms of epilepsy (e.g. continuous spikes and waves during slow sleep \[CSWS\], Landau-Kleffner-syndrome)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To evaluate the efficacy of levetiracetam in the treatment of children with BECTS compared to sulthiame

Timeframe: 6 months

Trial details

NCT IDNCT00471744

SponsorLudwig-Maximilians - University of Munich

Sponsor typeOTHER

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Epilepsy, Rolandic trials