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The purpose of this study is to investigate the taste preference in children of 3 different flavours of the ESL oral suspension.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESL Banana taste | Drug | oral suspension with Banana flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Bacos Cosma Medical Centre | Timișoara | Timiș County | 300314 | Romania | ||
| Psychiatry Clinical Hospital "Prof. Dr. Alexandru Obregia" - Department of Pediatric |
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| ID | Title | Description |
|---|---|---|
| FG000 | Eslicarbazepine Acetate | Eslicarbazepine acetate (ESL) was supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| ESL Grape taste | Drug | oral suspension with Grape flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses. |
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| ESL Tutti-Frutti taste | Drug | oral suspension with Tutti-Frutti flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses. |
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| Bucharest |
| 041914 |
| Romania |
| Neurology Outpatient Clinic for children and adults | Bardejov | 08501 | Slovakia |
| COMPLETED |
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| NOT COMPLETED |
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A total of 38 subjects were screened. All of these subjects were randomised and completed the trial
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| ID | Title | Description |
|---|---|---|
| BG000 | Eslicarbazepine Acetate | Eslicarbazepine acetate (ESL) was supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale (0-10 cm VAS) | single Study Day |
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After the first tasting of study treatment until 1-4 days after tasting the IMP
The study comprised a Screening Visit (not more than 1 month before the Study Day), a single Study Day (which could occur on the same day as the Screening Visit), and a follow-up telephone contact interview (that was to be performed between 1 and 4 days after the Study Day). Thus, individual study durations may have been between 2-6 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Eslicarbazepine Acetate | Eslicarbazepine acetate (ESL) supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses. | 1 | 38 | 0 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Laryngitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director R&D | BIAL - Portela & Cª, S.A. | 351-22-9866100 | clinical.trials@bial.com |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C416835 | eslicarbazepine acetate |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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