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

• ClinicalTrials.gov Identifier: NCT02021461
• Recruitment Status: Completed
• First Posted: December 27, 2013
• Results First Posted: April 3, 2014
• Last Update Posted: April 3, 2014
• Sponsor: Bial - Portela C S.A.
• Information provided by (Responsible Party): Bial - Portela C S.A.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Epilepsy	Drug: ESL Banana taste; Drug: ESL Grape taste; Drug: ESL Tutti-Frutti taste	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• 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 Start Date: December 2012
• Actual Primary Completion Date: December 2012
• Actual Study Completion Date: December 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: ESL Banana taste; Subjects were to be enrolled until there were at least 30 evaluable subjects (of whom at least 60% were <7 years of age). Evaluable subjects were those who completed 3 Visual analogue scale (VAS), 1 for each of the 3 tasting steps with the 3 flavoured oral suspensions.	Drug: ESL Banana taste; oral suspension with Banana flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.; Other Name: Eslicarbazepine acetate (ESL)
Experimental: ESL Grape taste; Subjects were to be enrolled until there were at least 30 evaluable subjects (of whom at least 60% were <7 years of age). Evaluable subjects were those who completed 3 Visual analogue scale (VAS), 1 for each of the 3 tasting steps with the 3 flavoured oral suspensions.	Drug: ESL Grape taste; oral suspension with Grape flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.; Other Name: Eslicarbazepine acetate (ESL)
Experimental: ESL Tutti-Frutti taste; Subjects were to be enrolled until there were at least 30 evaluable subjects (of whom at least 60% were <7 years of age). Evaluable subjects were those who completed 3 Visual analogue scale (VAS), 1 for each of the 3 tasting steps with the 3 flavoured oral suspensions.	Drug: 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.; Other Name: Eslicarbazepine acetate (ESL)

Outcome Measures

Primary Outcome Measures :

1. Assessment of Taste Preference [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 5 Years to 8 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Romania

Dr. Bacos Cosma Medical Centre

Timisoara, Timis County, Romania, 300314

Psychiatry Clinical Hospital "Prof. Dr. Alexandru Obregia" - Department of Pediatric

Bucharest, Romania, 041914

Slovakia

Neurology Outpatient Clinic for children and adults

Bardejov, Slovakia, 08501

Sponsors and Collaborators

Bial - Portela C S.A.

More Information

• Responsible Party: Bial - Portela C S.A.
• ClinicalTrials.gov Identifier: NCT02021461
• Other Study ID Numbers: BIA-2093-212
• First Posted: December 27, 2013
• Results First Posted: April 3, 2014
• Last Update Posted: April 3, 2014
• Last Verified: February 2014

Additional relevant MeSH terms:

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eslicarbazepine acetate; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action