HEAD-to-head evaluation of the antiepileptic drugs, levetiracetam versus sulthiame in a German multicentre, double-blind, controlled trial in children with benign epilepsy with centrotemporal spikes
| ISRCTN | ISRCTN97864911 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97864911 |
| ClinicalTrials.gov number | NCT00471744 |
| Secondary identifying numbers | HEAD-STUDIE |
- Submission date
- 16/09/2005
- Registration date
- 21/04/2006
- Last edited
- 29/09/2008
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Florian Heinen
Scientific
Scientific
Abteilung für Pädiatrische Neurologie und Entwicklungsneurologie
Dr. von Haunersches Kinderspital
Lindwurmstr. 4
München
80337
Germany
| Phone | +49 (0)89 5160 7851 |
|---|---|
| florian.heinen@med.uni-muenchen.de |
Study information
| Study design | Multicentre, double-blind, randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | HEAD |
| Study objectives | 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(s) | Ethical approval not yet received as of 21/04/06 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Levetiracetam and sulthiame |
| Primary outcome measure | 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 study start date | 01/01/2006 |
| Completion date | 30/06/2007 |
| Reason abandoned (if study stopped) | Insufficient recruitment |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 30/06/2007 |
Locations
Countries of recruitment
- Germany
Study participating centre
Abteilung für Pädiatrische Neurologie und Entwicklungsneurologie
München
80337
Germany
80337
Germany
Sponsor information
Hospital of the University of Munich, Dr. von Haunerschen Childrens Hospital (Germany)
Hospital/treatment centre
Hospital/treatment centre
Lindwurmstr. 4
München
80337
Germany
Funders
Funder type
Industry
Funded by UCB Pharma GmbH (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
