Childhood epilepsy MedDRA version: 9.1 Level: LLT Classification code 10015037 Term: Epilepsy
Conditions
Interventions
Trade Name: Class of medicines - anticonvulsants
Product Name: Class of medicinal products - anticonvulsants
Product Code: Not applicable
Pharmaceutical
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To prospectively determine the nature and rate of adverse drug reactions, or side effects, in children on anticonvulsants. ;Primary end point(s): This is primarily an epidemiological study to determine the frequency and severity of the side effects of anticonvulsant medications in children with epilepsy. The primary endpoint is therefore determined by the proposed length of the period of observation, which is three years.; Secondary Objective: 1. To prospectively evaluate the effect of anticonvulsants on behaviour and cognitive function in children with epilepsy prior to, during and after treatment with anticonvulsant medication 2. To establish a register of children on anticonvulsants to be able to prospectively collect information on safety | — |
Countries
United Kingdom
Outcome results
None listed