NCT02021461

Double-blind Study in Paediatric Epileptic to Compare the Subject Preference for ESL Suspension Formulation With Alternative Flavours

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 5 Years – 8 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	ESL Banana taste	oral suspension with Banana flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
DRUG	ESL Grape taste	oral suspension with Grape flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
DRUG	ESL Tutti-Frutti taste	oral suspension with Tutti-Frutti flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.

Timeline

• Start date: 2012-12-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2013-12-27
• Last updated: 2014-04-03
• Results posted: 2014-04-03

Locations

3 sites across 2 countries: Romania, Slovakia