Ignite Creation Date:
2025-12-24 @ 12:30 PM
Ignite Modification Date:
2025-12-27 @ 10:43 PM
Study NCT ID:
NCT02021461
Status:
COMPLETED
Last Update Posted:
2014-04-03
First Post:
2013-12-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Double-blind Study in Paediatric Epileptic to Compare the Subject Preference for ESL Suspension Formulation With Alternative Flavours
Sponsor:
Bial - Portela C S.A.
Organization:
Study Overview
Official Title:
Double-blind Study in Paediatric Epileptic Subjects Aged From 5 to Less Than 8 Years to Compare the Subject Preference for ESL Suspension Formulation With Alternative Flavours
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate the taste preference in children of 3 different flavours of the ESL oral suspension.
Detailed Description:
Children between the age of 5 and \<8 years who are patients of the participating investigators will be screened for participation in the study. This may be at a regularly planned visit or the investigators may invite children who would be suitable candidates. Children who agree to participate will be invited to come back to the clinic on a single Study Day and will be randomised to a particular sequence of flavours. On the Study Day, all children will be given 3 different flavoured samples of Eslicarbazepine acetate (ESL) oral suspension for tasting, in the sequence to which they were randomised, in a double-blind, standardized setting. Each sample will consist of 2.5 mL and is to be given with a spoon in a double-blind manner, and is not to be swallowed. After tasting and spitting out each sample the child will be asked to rate the taste on a 10 cm visual analogue scale incorporating a facial hedonic scale. At the end of the session, the child will also be asked which flavour they thought tasted the best and which tasted the worst, to assess overall taste. A follow-up telephone contact interview will be performed between 1 and 4 days after the Study Day to collect adverse event (AE) data.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: