HEAD-Study Optimizing the Treatment of Children With BECTS (HEAD)

January 28, 2009 updated by: Ludwig-Maximilians - University of Munich

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • München, Germany, 81371
        • Dr. Von Haunersches Kinderspital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Other forms of epilepsy (e.g. continuous spikes and waves during slow sleep [CSWS], Landau-Kleffner-syndrome)
  2. Preceding treatment with antiepileptic drugs
  3. Mental Retardation (intelligence quotient [IQ] <85)
  4. Focal neurological deficit
  5. Relevant major internistic disease (e.g. hepatopathy, nephropathy, endocrinopathy)
  6. Participation in another clinical trial within the last 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the efficacy of levetiracetam in the treatment of children with BECTS compared to sulthiame
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability
Time Frame: 6 months
6 months
Cognitive effects
Time Frame: 6 months
6 months
Efficacy on EEG pattern
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig-Maximilians - University of Munich

Investigators

  • Principal Investigator: F Heinen, Prof., Ludwigs-Maximilians-Universität München

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Study Completion (ACTUAL)

July 1, 2008

Study Registration Dates

First Submitted

May 8, 2007

First Submitted That Met QC Criteria

May 8, 2007

First Posted (ESTIMATE)

May 10, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

January 29, 2009

Last Update Submitted That Met QC Criteria

January 28, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-004468-22
  • ISRCTN 97864911

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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