Double-blind Study in Paediatric Epileptic to Compare the Subject Preference for ESL Suspension Formulation With Alternative Flavours
February 24, 2014 updated by: Bial - Portela C S.A.
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
The purpose of this study is to investigate the taste preference in children of 3 different flavours of the ESL oral suspension.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
38
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bucharest, Romania, 041914
- Psychiatry Clinical Hospital "Prof. Dr. Alexandru Obregia" - Department of Pediatric
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Timis County
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Timisoara, Timis County, Romania, 300314
- Dr. Bacos Cosma Medical Centre
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Bardejov, Slovakia, 08501
- Neurology Outpatient Clinic for children and adults
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 8 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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oral suspension with Banana flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
Other Names:
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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.
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oral suspension with Grape flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
Other Names:
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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.
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oral suspension with Tutti-Frutti flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assessment of Taste Preference
Time Frame: single Study Day
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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.
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single Study Day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
December 20, 2013
First Submitted That Met QC Criteria
December 20, 2013
First Posted (Estimate)
December 27, 2013
Study Record Updates
Last Update Posted (Estimate)
April 3, 2014
Last Update Submitted That Met QC Criteria
February 24, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIA-2093-212
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.