Prediction of Childhood Epilepsy Outcome in Bangladesh

This study has been completed.

First Received on September 27, 2006. Last Updated on December 22, 2006 History of Changes

Sponsor:	Institute of Child Health
Information provided by:	Institute of Child Health
ClinicalTrials.gov Identifier:	NCT00381537

Purpose

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

Condition	Intervention
Epilepsy	Drug: phenobarbitone Drug: carbamazepine

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy

Drug Information available for: Phenobarbital Phenobarbital sodium Carbamazepine

U.S. FDA Resources

Further study details as provided by Institute of Child Health:

Estimated Enrollment:

Eligibility

Ages Eligible for Study:	2 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00381537

Locations

Bangladesh
Children’s Hospital Dhaka (Shishu) Bangladesh.
Sher-e-Bangla Nagar, Dhaka 1207, Bangladesh
United Kingdom
Institute of Child Health
London, United Kingdom, WC1N 1EH

Sponsors and Collaborators

Institute of Child Health

Investigators

Principal Investigator:	Brian Neville, Professor	Institute of Child Health
Principal Investigator:	Selina Banu, Dr	Children’s Hospital Dhaka (Shishu) Bangladesh.

More Information

No publications provided by Institute of Child Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2006 Dec 4.

ClinicalTrials.gov Identifier:	NCT00381537 History of Changes
Other Study ID Numbers:	99NR58
Study First Received:	September 27, 2006
Last Updated:	December 22, 2006
Health Authority:	Bangladesh: Ethical Review Committee

Keywords provided by Institute of Child Health:

childhood epilepsy
Active childhood epilepsy

Additional relevant MeSH terms:

Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Carbamazepine
Phenobarbital
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents

Therapeutic Uses
Anticonvulsants
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Hypnotics and Sedatives
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
GABA Agents

ClinicalTrials.gov processed this record on February 12, 2012