Prediction of Childhood Epilepsy Outcome in Bangladesh

This study has been completed.

First Received: September 27, 2006 Last Updated: 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:	Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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 National Clinical Trials Identifier (NCT ID):

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.

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

Keywords provided by Institute of Child Health:

childhood epilepsy
Active childhood epilepsy

Additional relevant MeSH terms:

Phenobarbital
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Excitatory Amino Acid Agents
Brain Diseases
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Analgesics
Excitatory Amino Acid Antagonists

Tranquilizing Agents
Nervous System Diseases
Central Nervous System Diseases
Central Nervous System Depressants
Antimanic Agents
Pharmacologic Actions
Carbamazepine
Analgesics, Non-Narcotic
Epilepsy
GABA Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on November 27, 2009