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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bial - Portela C S.A.
• Treatments: Eslicarbazepine acetate

Criteria

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.