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

Phase 1

• Conditions: Childhood epilepsy; MedDRA version: 9.1 Level: LLT Classification code 10015037 Term: Epilepsy

• Registration Number: EUCTR2007-000565-37-GB
• Lead Sponsor: niversity of Nottingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-07-31
• Study Completion: 2011-12-31
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 300

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified