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

NCT02021461 | Completed Phase 2 Results

• 1 other identifier: BIA-2093-212
• Study Type: interventional
• Target: 38
• Locations: 2 countries
• Sites: 3

Brief Summary

The purpose of this study is to investigate the taste preference in children of 3 different flavours of the ESL oral suspension.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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.

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.

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.

Drug: ESL Tutti-Frutti taste

Interventions

ESL Banana taste DRUG

oral suspension with Banana flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.

Also known as: Eslicarbazepine acetate (ESL)

ESL Banana taste

ESL Grape taste DRUG

oral suspension with Grape flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.

Also known as: Eslicarbazepine acetate (ESL)

ESL Grape taste

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.

Also known as: Eslicarbazepine acetate (ESL)

ESL Tutti-Frutti taste

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (3)

Dr. Bacos Cosma Medical Centre

Timișoara, Timiș County, 300314, Romania

Location

Psychiatry Clinical Hospital "Prof. Dr. Alexandru Obregia" - Department of Pediatric

Bucharest, 041914, Romania

Location

Neurology Outpatient Clinic for children and adults

Bardejov, 08501, Slovakia

Location

MeSH Terms

Conditions

Epilepsy

Interventions

eslicarbazepine acetate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Director R&D
• Organization: BIAL - Portela & Cª, S.A.

clinical.trials@bial.com

351-22-9866100

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2013
• First Posted: December 27, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 3, 2014
• Results First Posted: April 3, 2014

Record last verified: 2014-02

Locations

RO (2); SL (1)