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

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02021461
• Other study ID #: BIA-2093-212
• Status: Completed
• Phase: Phase 2
• First received: December 20, 2013
• Last updated: February 24, 2014
• Start date: December 2012
• Est. completion date: December 2012

Study information

• Verified date: February 2014
• Source: Bial - Portela C S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovakia: State Institute for Drug Control
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 8 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• ESL Banana taste
oral suspension with Banana flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
• ESL Grape taste
oral suspension with Grape flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
• ESL Tutti-Frutti taste
oral suspension with Tutti-Frutti flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.

Locations

Country	Name	City	State
Romania	Psychiatry Clinical Hospital "Prof. Dr. Alexandru Obregia" - Department of Pediatric	Bucharest
Romania	Dr. Bacos Cosma Medical Centre	Timisoara	Timis County
Slovakia	Neurology Outpatient Clinic for children and adults	Bardejov

Sponsors (1)

Lead Sponsor	Collaborator
Bial - Portela C S.A.

Countries where clinical trial is conducted

Romania,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	single Study Day	No