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NCT00381537 Clinical Trial

Prediction of Childhood Epilepsy Outcome in Bangladesh

Epilepsy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00381537
Other study ID # 99NR58
Secondary ID
Status Completed
Phase N/A
First received September 27, 2006
Last updated December 22, 2006

Study information
Verified date December 2006
Source Institute of Child Health
Contact n/a
Is FDA regulated No
Health authority Bangladesh: Ethical Review Committee
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 92
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 16 Years
Eligibility 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.

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• phenobarbitone

• carbamazepine

Locations
Country Name City State
Bangladesh Children’s Hospital Dhaka (Shishu) Bangladesh. Sher-e-Bangla Nagar, Dhaka 1207
United Kingdom Institute of Child Health London

Sponsors (1)
Lead Sponsor Collaborator
Institute of Child Health

Countries where clinical trial is conducted

Bangladesh,  United Kingdom, 

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