Comparison of three different flavours of Eslicarbazepine Acetate (BIA 2-093) oral suspension by children aged 5 to less than 8 years old.

Conditions: Epilepsy / Partial onset seizures
MedDRA version: 15.1Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2012-003137-41-SK

Lead Sponsor: BIAL - Portela & Ca, S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>• The 10 cm visual analog scale.<br>• The subject’s assessment of the overall taste (best, worst).<br>;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 Outcome Measures

Name	Time	Method
Secondary end point(s): Safety:<br>• 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.