Clinical trial NCT02021461: Double-blind Study in Paediatric Epileptic to Compare the Subject Preference for ESL Suspension Formulation With Alternative Flavours
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epilepsy
Lead sponsor: Bial - Portela C S.A.
Sponsor class: INDUSTRY
First posted: 2013-12-27
Enrollment: 38
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of Taste Preference
timeFrame: single Study Day
Secondary outcomes:
Other outcomes:
Locations:
city: Timisoara
country: Romania
facility: Dr. Bacos Cosma Medical Centre
state: Timis County
city: Bucharest
country: Romania
facility: Psychiatry Clinical Hospital "Prof. Dr. Alexandru Obregia" - Department of Pediatric
city: Bardejov
country: Slovakia
facility: Neurology Outpatient Clinic for children and adults
Study officials:
References: