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

Phase 2

Completed

• Conditions: Epilepsy
• Interventions: Drug: ESL Banana taste; Drug: ESL Grape taste; Drug: ESL Tutti-Frutti taste

• Registration Number: NCT02021461
• Lead Sponsor: Bial - Portela C S.A.

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 Timeline

• Study Start: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2013-12-20
• Study First Submitted QC: 2013-12-20
• Study First Posted: 2013-12-27
• Results First Submitted: 2014-01-09
• Status Verified: 2014-02
• Results First Submitted QC: 2014-02-24
• Last Update Submitted: 2014-02-24
• Results First Posted: 2014-04-03
• Last Update Posted: 2014-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• A written informed consent form signed by the subject's parent(s) or guardian(s) and an assent form for any 7-year-old subjects signed by subjects.
• Male or female, between the age of 5 to <8 years.
• Diagnosed with partial-onset epilepsy.
• Is considered, in the opinion of the investigator, to be able to make the required taste assessment.

Exclusion Criteria

• Uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological, or oncology disorder.
• Known hypersensitivity to carboxamide derivatives or tricyclic antidepressants.
• Strong congestion, flu, or any other acute illness that could influence the child's sense of taste.
• A known swallowing or taste perception problem.
• Currently or previously treated with ESL.
• Concomitant participation in another drug clinical trial.
• Any other condition or circumstance that, in the opinion of the investigator, could compromise the subject's ability to comply with the study protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ESL Banana taste	ESL Banana taste	Subjects were to be enrolled until there were at least 30 evaluable subjects (of whom at least 60% were \<7 years of age). Evaluable subjects were those who completed 3 Visual analogue scale (VAS), 1 for each of the 3 tasting steps with the 3 flavoured oral suspensions.
ESL Grape taste	ESL Grape taste	Subjects were to be enrolled until there were at least 30 evaluable subjects (of whom at least 60% were \<7 years of age). Evaluable subjects were those who completed 3 Visual analogue scale (VAS), 1 for each of the 3 tasting steps with the 3 flavoured oral suspensions.
ESL Tutti-Frutti taste	ESL Tutti-Frutti taste	Subjects were to be enrolled until there were at least 30 evaluable subjects (of whom at least 60% were \<7 years of age). Evaluable subjects were those who completed 3 Visual analogue scale (VAS), 1 for each of the 3 tasting steps with the 3 flavoured oral suspensions.

Primary Outcome Measures

Name	Time	Method
Assessment of Taste Preference	single Study Day	Subject preference for 3 flavours of the ESL oral suspension was assessed based on a measured score using a 0-10 cm (minimum and maximum measured values) Visual Analogue Scale (VAS). Higher values represent the stronger preference.

Trial Locations

Locations (3)

Psychiatry Clinical Hospital "Prof. Dr. Alexandru Obregia" - Department of Pediatric; 🇷🇴 Bucharest, Romania

Neurology Outpatient Clinic for children and adults; 🇸🇰 Bardejov, Slovakia

Dr. Bacos Cosma Medical Centre; 🇷🇴 Timisoara, Timis County, Romania