Epilepsy
Conditions
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.
Interventions
DRUGESL Banana taste
oral suspension with Banana flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
DRUGESL Grape taste
oral suspension with Grape flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
DRUGESL Tutti-Frutti taste
oral suspension with Tutti-Frutti flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
Sponsors
Bial - Portela C S.A.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 8 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Romania, Slovakia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Eslicarbazepine Acetate Eslicarbazepine acetate (ESL) was supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses. | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | Eslicarbazepine Acetate |
|---|---|
| Age, Continuous | 6.1 years STANDARD_DEVIATION 0.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 38 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 38 |
| serious Total, serious adverse events | 1 / 38 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESL Banana Taste | Assessment of Taste Preference | 5.8 units on a scale (0-10 cm VAS) | Standard Deviation 3.5 |
| ESL Grape Taste | Assessment of Taste Preference | 5.8 units on a scale (0-10 cm VAS) | Standard Deviation 3.5 |
| ESL Tutti-Frutti Taste | Assessment of Taste Preference | 7.1 units on a scale (0-10 cm VAS) | Standard Deviation 3.2 |