Trial Outcomes & Findings for Double-blind Study in Paediatric Epileptic to Compare the Subject Preference for ESL Suspension Formulation With Alternative Flavours (NCT NCT02021461)

NCT ID: NCT02021461

Last Updated: 2014-04-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

38 participants

Primary outcome timeframe

single Study Day

Results posted on

2014-04-03

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	38
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Eslicarbazepine Acetate n=38 Participants 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.
Age, Continuous	6.1 years STANDARD_DEVIATION 0.8 • n=99 Participants
Sex: Female, Male Female	17 Participants n=99 Participants
Sex: Female, Male Male	21 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	38 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: single Study Day

Outcome measures

Outcome measures
Measure	ESL Banana Taste n=38 Participants 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 Grape Taste n=38 Participants 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 Tutti-Frutti Taste n=38 Participants 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
Assessment of Taste Preference	5.8 units on a scale (0-10 cm VAS) Standard Deviation 3.5	5.8 units on a scale (0-10 cm VAS) Standard Deviation 3.5	7.1 units on a scale (0-10 cm VAS) Standard Deviation 3.2

Adverse Events

Eslicarbazepine Acetate

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Eslicarbazepine Acetate n=38 participants at risk 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.
Infections and infestations Laryngitis	2.6% 1/38 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	2.6% 1/38 • Number of events 1 • 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.

Other adverse events

Adverse event data not reported

Additional Information

Director R&D

BIAL - Portela & Cª, S.A.

Phone: 351-22-9866100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER