EpilepsyPhase 2NCT02021461
Double-blind Study in Paediatric Epileptic to Compare the Subject Preference for ESL Suspension Formulation With Alternative Flavours
A Phase 2 study testing ESL Banana taste, ESL Grape taste and ESL Tutti-Frutti taste in people with Epilepsy, run by Bial - Portela C S.A. at 3 sites in 2 countries.
Trial summary
The purpose of this study is to investigate the taste preference in children of 3 different flavours of the ESL oral suspension. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- ESL Banana taste, ESL Grape taste and ESL Tutti-Frutti taste
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Dec 2012to Dec 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Romania2 sites
Psychiatry Clinical Hospital "Prof. Dr. Alexandru Obregia" - Department of Pediatric
Bucharest, 041914
Dr. Bacos Cosma Medical Centre
Timișoara, Timiș County, 300314
Slovakia1 site
Neurology Outpatient Clinic for children and adults
Bardejov, 08501
About this study
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
The purpose of this study is to investigate the taste preference in children of 3 different flavours of the ESL oral suspension.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- ESL Banana taste, ESL Grape taste, ESL Tutti-Frutti taste
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESL Banana tasteDrug
Also called Eslicarbazepine acetate (ESL)
oral suspension with Banana flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
ESL Grape tasteDrug
Also called Eslicarbazepine acetate (ESL)
oral suspension with Grape flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
ESL Tutti-Frutti tasteDrug
Also called Eslicarbazepine acetate (ESL)
oral suspension with Tutti-Frutti flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
| Study group | Role | What they receive |
|---|---|---|
| ESL Banana taste | Experimental | 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. Receives: Drug: ESL Banana taste |
| ESL Grape taste | Experimental | 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. Receives: Drug: ESL Grape taste |
| ESL Tutti-Frutti taste | Experimental | 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. Receives: Drug: ESL Tutti-Frutti taste |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: single Study Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bial - Portela C S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021461
- Sponsor's protocol ID
- BIA-2093-212
- Status last verified
- Feb 2014
- First submitted
- 20 Dec 2013
- Last updated
- 3 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02021461
- Acronym / sponsor ID
- BIA-2093-212
- Conditions
- Epilepsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Dec 2013 (estimated)
- Results
- Posted 3 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the taste preference in children of 3 different flavours of the ESL oral suspension.
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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ESL Banana taste | Experimental | Drug: ESL Banana tasteSubjects 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. |
| ESL Grape taste | Experimental | Drug: ESL Grape tasteSubjects 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. |
| ESL Tutti-Frutti taste | Experimental | Drug: ESL Tutti-Frutti tasteSubjects 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. |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESL Banana tasteAlso: Eslicarbazepine acetate (ESL)oral suspension with Banana flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses. | Drug | ESL Banana taste |
| ESL Grape tasteAlso: Eslicarbazepine acetate (ESL)oral suspension with Grape flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses. | Drug | ESL Grape taste |
| ESL Tutti-Frutti tasteAlso: Eslicarbazepine acetate (ESL)oral suspension with Tutti-Frutti flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses. | Drug | ESL Tutti-Frutti taste |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ESL Banana taste, ESL Grape taste and ESL Tutti-Frutti taste in people with Epilepsy, run by Bial - Portela C S.A. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Romania, Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Taste Preference (time frame: single Study Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2014; AzTrials last refreshed its copy on 6 Nov 2026.