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

Study Overview
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Brief Summary
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The purpose of this study is to investigate the taste preference in children of 3 different flavours of the ESL oral suspension.

Detailed Description
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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.

Official Title
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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

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: ESL Banana taste
* Drug: ESL Grape taste
* Drug: ESL Tutti-Frutti taste


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESL Banana taste<br>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. | Drug: ESL Banana taste<br>* oral suspension with Banana flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.<br>* Other names: Eslicarbazepine acetate (ESL);|
| Experimental: ESL Grape taste<br>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. | Drug: ESL Grape taste<br>* oral suspension with Grape flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.<br>* Other names: Eslicarbazepine acetate (ESL);|
| Experimental: ESL Tutti-Frutti taste<br>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. | Drug: ESL Tutti-Frutti taste<br>* oral suspension with Tutti-Frutti flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.<br>* Other names: Eslicarbazepine acetate (ESL);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Taste Preference | 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. | single Study Day |