A Prospective Study to Determine the Adverse Drug Reactions Profile of Anticonvulsants in Children - A Study of Adverse Drug Reactions to Anticonvulsants in Children

niversity of Nottingham0 sites300 target enrollmentJuly 31, 2007

Overview

No summary available.

Registry

who.int

Start Date

July 31, 2007

End Date

December 31, 2011

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

niversity of Nottingham

•1\.Children (aged 0\-16 years) attending outpatient clinics, as well as inpatients, who are receiving one or more anticonvulsants for epilepsy (Group A).
•2\.Children aged 4\-16 years commencing anticonvulsant therapy for epilepsy for the first time (for group B)
•3\.Children aged 4\-16 years who may stop taking anticonvulsant therapy for epilepsy in the following year (for group C)
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years)
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years)
•F.1\.3\.1 Number of subjects for this age range

•1\. Presence of any concomitant condition or circumstances which, in the opinion of the investigator, would render the patient unsuitable for the study, such as a known history of alcohol or drug abuse.
•2\. Children aged under 4 years and those aged 4\-16 years with significant pre\-existing learning difficulties will be excluded from the cognitive and behavioural assessment portion of the study (groups B \& C) as no standardised assessments exist for these groups of patients.