Prediction of Childhood Epilepsy Outcome in Bangladesh | NCT00381537

Studies
Prediction of Childhood Epilepsy Outcome in Bangladesh

NCT00381537

Sponsor

Institute of Child Health

Status

Completed

Last Update Posted

Dec 25, 2006Estimated

Enrollment

Phase

Not Applicable

Conditions

Epilepsy

Interventions

phenobarbitone
carbamazepine

Countries

Bangladesh
United Kingdom

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

Status Module

Record Verification Date

Dec 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 27, 2006

First Submission Date that Met QC Criteria

Sep 27, 2006

First Posted Date

Sep 28, 2006Estimated

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

Dec 22, 2006

Last Update Posted Date

Dec 25, 2006Estimated

Description Module

Brief Summary

Randomised controlled trial of the use of phenobarbitone and carbamazepine in childhood epilepsy in Bangladesh with particular reference to behavioural side effects.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Active epilepsy
Aged 2-15 years

Exclusion Criteria:

Excluded absence
Myoclonic and malignant epilepsy syndromes
Major motor and cognitive impairments
Those currently receiving antiepilepsy drugs.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Brian Neville, Professor	Institute of Child Health	Principal Investigator
Selina Banu, Dr	Children's Hospital Dhaka (Shishu) Bangladesh.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital Dhaka (Shishu) Bangladesh.		Sher-e-Bangla Nagar, Dhaka 1207			Bangladesh
Institute of Child Health

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17145735	Derived	Banu SH, Jahan M, Koli UK, Ferdousi S, Khan NZ, Neville B. Side effects of phenobarbital and carbamazepine in childhood epilepsy: randomised controlled trial. BMJ. 2007 Jun 9;334(7605):1207. doi: 10.1136/bmj.39022.436389.BE. Epub 2006 Dec 4.

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D010634	Phenobarbital
D002220	Carbamazepine

ID	Term
D001463	Barbiturates
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring

Name	Type	Description	Arm Group Labels	Other Names
phenobarbitone	Drug
carbamazepine	Drug