HEAD-Study Optimizing the Treatment of Children With BECTS | NCT00471744

Studies
HEAD-Study Optimizing the Treatment of Children With BECTS

NCT00471744

Sponsor

Ludwig-Maximilians - University of Munich

Status

Terminated

Last Update Posted

Jan 29, 2009Estimated

Enrollment

44Actual

Phase

Phase 3

Conditions

Epilepsy, Rolandic

Interventions

Treatment with levetiracetam or sulthiame over a six-month period.

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
ISRCTN 97864911

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

low patient number after 2 years recruiting

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Not provided

Completion Date

Jul 2008Actual

First Submitted Date

May 8, 2007

First Submission Date that Met QC Criteria

May 8, 2007

First Posted Date

May 10, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2009

Last Update Posted Date

Jan 29, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Name	Type	Description	Arm Group Labels	Other Names
Treatment with levetiracetam or sulthiame over a six-month period.	Drug

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
F Heinen, Prof.	Ludwigs-Maximilians-Universität München	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr. von Haunersches Kinderspital		München		81371	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34554571	Derived	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.

ID	Term
D004828	Epilepsies, Partial
D004827	Epilepsy
D001927	Brain Diseases
D002493	Central Nervous System Diseases

ID	Term
D000081	Acetamides
D000577	Amides
D009930	Organic Chemicals
D000085	Acetates
D000144

ID	Term
D013812	Therapeutics
D000077287	Levetiracetam