NCT00381537

Brief Summary

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

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2006

Completed
Last Updated

December 25, 2006

Status Verified

December 1, 2006

First QC Date

September 27, 2006

Last Update Submit

December 22, 2006

Conditions

Epilepsy

Keywords

childhood epilepsyActive childhood epilepsy

Interventions

phenobarbitoneDRUG
carbamazepineDRUG

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Active epilepsy
  • Aged 2-15 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hospital Dhaka (Shishu) Bangladesh.

Sher-e-Bangla Nagar, Dhaka 1207, Bangladesh

Location

Institute of Child Health

London, WC1N 1EH, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 17145735DERIVED

MeSH Terms

Conditions

Epilepsy

Interventions

PhenobarbitalCarbamazepine

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

BarbituratesPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Brian Neville, Professor

    Institute of Child Health

    PRINCIPAL INVESTIGATOR

  • Selina Banu, Dr

    Children's Hospital Dhaka (Shishu) Bangladesh.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 27, 2006

First Posted

September 28, 2006

Last Updated

December 25, 2006

Record last verified: 2006-12

Locations

BA(1)GB(1)