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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE December 20, 2013
First Posted Date  ICMJE December 27, 2013
Results First Submitted Date  ICMJE January 9, 2014
Results First Posted Date  ICMJE April 3, 2014
Last Update Posted Date April 3, 2014
Study Start Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 20, 2013)
Assessment of Taste Preference [ Time Frame: single Study Day ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Double-blind Study in Paediatric Epileptic to Compare the Subject Preference for ESL Suspension Formulation With Alternative Flavours
Official Title  ICMJE 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
Brief Summary 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition  ICMJE Epilepsy
Intervention  ICMJE
  • 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)
  • 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)
  • 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)
Study Arms  ICMJE
  • 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.
    Intervention: Drug: ESL Banana taste
  • 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.
    Intervention: Drug: ESL Grape taste
  • 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.
    Intervention: Drug: ESL Tutti-Frutti taste
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 20, 2013)
38
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Romania,   Slovakia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02021461
Other Study ID Numbers  ICMJE BIA-2093-212
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bial - Portela C S.A.
Study Sponsor  ICMJE Bial - Portela C S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bial - Portela C S.A.
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP