Epilepsy, RolandicPhase 3HEADNCT00471744
HEAD-Study Optimizing the Treatment of Children With BECTS
A Phase 3 study testing Treatment with levetiracetam or sulthiame over a six-month period. in people with Epilepsy, Rolandic, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Epilepsy, Rolandic
- What is being tested?
- Treatment with levetiracetam or sulthiame over a six-month period.
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2006to Jul 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Other forms of epilepsy (e.g. continuous spikes and waves during slow sleep [CSWS], Landau-Kleffner-syndrome)
- Preceding treatment with antiepileptic drugs
- Mental Retardation (intelligence quotient [IQ] <85)
- Focal neurological deficit
- Relevant major internistic disease (e.g. hepatopathy, nephropathy, endocrinopathy)
- Participation in another clinical trial within the last 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Epilepsy, Rolandic
- Being tested
- Treatment with levetiracetam or sulthiame over a six-month period.
- Keywords
- benign epilepsy, pediatrics, children, rolandic epilepsy, levetiracetam, sulthiame
- Medical subject headings
- Epilepsy, Rolandic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with levetiracetam or sulthiame over a six-month period.Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of levetiracetam in the treatment of children with BECTS compared to sulthiame
Measured: 6 months
Secondary outcomes (3)
Safety and tolerability
Measured: 6 months
Cognitive effects
Measured: 6 months
Efficacy on EEG pattern
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2007 (estimated)
- Study startJun 2006
- Study completionJul 2008
Why it stopped: low patient number after 2 years recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epilepsy, RolandicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Investigators
- F Heinen, Prof., Principal investigator, Ludwigs-Maximilians-Universität München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00471744
- Sponsor's protocol ID
- 2005-004468-22
- Other IDs
- ISRCTN 97864911, 2005
- Acronym
- HEAD
- Status last verified
- Jan 2009
- First submitted
- 8 May 2007
- Last updated
- 29 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Milburn-McNulty P, Panebianco M, Marson AG. Sulthiame monotherapy for epilepsy. Cochrane Database Syst Rev. 2021 Sep 23;9(9):CD010062. doi: 10.1002/14651858.CD010062.pub3.
PubMed 34554571
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00471744
- Acronym / sponsor ID
- HEAD / 2005-004468-22
- Conditions
- Epilepsy, Rolandic
- Keywords
- benign epilepsy, pediatrics, children, rolandic epilepsy, levetiracetam, sulthiame
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low patient number after 2 years recruiting
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Jun 2006
- Study completion
- Jul 2008 (actual)
- First posted
- 10 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Other forms of epilepsy (e.g. continuous spikes and waves during slow sleep [CSWS], Landau-Kleffner-syndrome)
- Preceding treatment with antiepileptic drugs
- Mental Retardation (intelligence quotient [IQ] <85)
- Focal neurological deficit
- Relevant major internistic disease (e.g. hepatopathy, nephropathy, endocrinopathy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment with levetiracetam or sulthiame over a six-month period. | Drug | – |
Primary outcome
To evaluate the efficacy of levetiracetam in the treatment of children with BECTS compared to sulthiame
Time frame: 6 months
3 secondary outcomes
Safety and tolerability
Time frame: 6 months
Cognitive effects
Time frame: 6 months
Efficacy on EEG pattern
Time frame: 6 months
Results and safety
The study was stopped early (reason given: low patient number after 2 years recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2009.
- Derived from this study: PubMed 34554571Milburn-McNulty P, Panebianco M, Marson AG. Sulthiame monotherapy for epilepsy. Cochrane Database Syst Rev. 2021 Sep 23;9(9):CD010062. doi: 10.1002/14651858.CD010062.pub3.
Related trials for Epilepsy, Rolandic
Not yet recruiting
Peri-procedural Weighted Blanket Use for ECT
Post-ect Agitation, Post-ictal Agitation
Not yet recruiting
Accelerated iTBS for Depression and Suicidality
Major Depressive Disorder, Suicide
RecruitingObservational study
Music Perception in SeLECTs
Rolandic Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
F Heinen, Prof. principal investigator
Ludwigs-Maximilians-Universität München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Treatment with levetiracetam or sulthiame over a six-month period. in people with Epilepsy, Rolandic, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: low patient number after 2 years recruiting). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of levetiracetam in the treatment of children with BECTS compared to sulthiame (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00471744, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2009.