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

Phase 2CompletedNCT02021461

Bial - Portela C S.A.38 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

Conditions

Epilepsy

Interventions

ESL Banana tasteDRUG

oral suspension with Banana flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.

ESL Grape tasteDRUG

oral suspension with Grape flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.

ESL Tutti-Frutti tasteDRUG

oral suspension with Tutti-Frutti flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.

Eligibility

Sex: ALLMin age: 5 YearsMax age: 8 Years

Medical Language ↔ Plain English

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.

Locations (3)

Dr. Bacos Cosma Medical Centre

Timișoara, Timiș County, Romania

Psychiatry Clinical Hospital "Prof. Dr. Alexandru Obregia" - Department of Pediatric

Bucharest, Romania

Neurology Outpatient Clinic for children and adults

Bardejov, Slovakia

Outcomes

Primary Outcomes

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.

Time frame: single Study Day

Data from ClinicalTrials.gov

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