Condition category
Nervous System Diseases
Date applied
16/09/2005
Date assigned
21/04/2006
Last edited
29/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Florian Heinen

ORCID ID

Contact details

Abteilung für Pädiatrische Neurologie und Entwicklungsneurologie
Dr. von Haunersches Kinderspital
Lindwurmstr. 4
München
80337
Germany
+49 (0)89 5160 7851
florian.heinen@med.uni-muenchen.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00471744

Protocol/serial number

HEAD-STUDIE

Study information

Scientific title

Acronym

HEAD

Study hypothesis

Added as of 29/09/2008: Please note that this trial has been prematurely terminated on 01/07/2008 due to insufficient recruitment.

Hypothesis:
We hypothesise that levetiracetam (LEV) is as effective as sulthiame (STM) in the treatment of children with benign epilepsy with centrotemporal spikes (BECTS)

Ethics approval

Ethical approval not yet received as of 21/04/06

Study design

Multicentre, double-blind, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Benign epilepsy of childhood with centrotemporal spikes (BECTS)

Intervention

Patients entering the HEAD-STUDIE are either treated with levetiracetam or sulthiame over a six-month period. Patients are equally randomised to one of the two treatment regimens. Administration of medication as blinded capsules.

Please note that as of 08/05/2007 the anticipated start and end dates of this trial have now been updated to the following:
Anticipated start date: 01/06/2006
Anticipated end date: 31/12/2007

Intervention type

Drug

Phase

Not Specified

Drug names

Levetiracetam and sulthiame

Primary outcome measures

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

Secondary outcome measures

1. Safety and tolerability
2. Efficacy on EEG pattern
3. Cognitive effects

Overall trial start date

01/01/2006

Overall trial end date

30/06/2007

Reason abandoned

Insufficient recruitment

Eligibility

Participant 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 (≥8 years)

Inclusion criteria added/changed as of 08/05/2007:
1. Age between 5 and 14 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 (≥8 years)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

120

Participant 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

Recruitment start date

01/01/2006

Recruitment end date

30/06/2007

Locations

Countries of recruitment

Germany

Trial participating centre

Abteilung für Pädiatrische Neurologie und Entwicklungsneurologie
München
80337
Germany

Sponsor information

Organisation

Hospital of the University of Munich, Dr. von Haunerschen Children’s Hospital (Germany)

Sponsor details

Lindwurmstr. 4
München
80337
Germany

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Funded by UCB Pharma GmbH (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes