Epilepsy / Partial onset seizures MedDRA version: 15.1 Level: PT Classification code 10015037 Term: Epilepsy System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
BIAL - Portela & Ca, S.A.
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 |
|---|---|
| Main Objective: To investigate the taste preference in children for 3 different flavours of the ESL oral suspension.;Secondary Objective: Not applicable.;Primary end point(s): Subject preference of 3 flavors of the ESL suspension will be assessed using: • The 10 cm visual analog scale. • The subject’s assessment of the overall taste (best, worst). ;Timepoint(s) of evaluation of this end point: 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety: • Treatment-emergent adverse events (TEAEs) defined as all adverse events (AEs) with onset or worsening after an accidental swallowing of study treatment until 1-4 days after tasting the IMP;Timepoint(s) of evaluation of this end point: A follow-up interview will be performed between 1 and 4 days after the study day to collect adverse event data. | — |
Countries
Slovakia
Contacts
Public ContactDep. of Research and Development
BIAL - Portela & Ca, S.A.
Outcome results
None listed