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

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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:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition Epilepsy
Interventions Drug: ESL Banana taste
Drug: ESL Grape taste
Drug: ESL Tutti-Frutti taste
Enrollment 38
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Eslicarbazepine Acetate
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 38
Completed 38
Not Completed 0
Arm/Group Title Eslicarbazepine Acetate
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 38
Hide Baseline Analysis Population Description
A total of 38 subjects were screened. All of these subjects were randomised and completed the trial
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants
6.1  (0.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Female
17
  44.7%
Male
21
  55.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
38
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Assessment of Taste Preference
Hide Description 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.
Time Frame single Study Day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ESL Banana Taste ESL Grape Taste ESL Tutti-Frutti Taste
Hide Arm/Group Description:

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.

ESL Banana taste

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.

ESL Grape taste

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.

ESL Tutti-Frutti taste

Overall Number of Participants Analyzed 38 38 38
Mean (Standard Deviation)
Unit of Measure: units on a scale (0-10 cm VAS)
5.8  (3.5) 5.8  (3.5) 7.1  (3.2)
Time Frame After the first tasting of study treatment until 1-4 days after tasting the IMP
Adverse Event Reporting Description 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.
 
Arm/Group Title Eslicarbazepine Acetate
Hide Arm/Group Description 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.
All-Cause Mortality
Eslicarbazepine Acetate
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Eslicarbazepine Acetate
Affected / at Risk (%) # Events
Total   1/38 (2.63%)    
Infections and infestations   
Laryngitis  1  1/38 (2.63%)  1
Respiratory, thoracic and mediastinal disorders   
Acute Respiratory Failure  1  1/38 (2.63%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Eslicarbazepine Acetate
Affected / at Risk (%) # Events
Total   0/38 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director R&D
Organization: BIAL - Portela & Cª, S.A.
Phone: 351-22-9866100
EMail: clinical.trials@bial.com
Layout table for additonal information
Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT02021461     History of Changes
Other Study ID Numbers: BIA-2093-212
First Submitted: December 20, 2013
First Posted: December 27, 2013
Results First Submitted: January 9, 2014
Results First Posted: April 3, 2014
Last Update Posted: April 3, 2014