Phase 2
Completed N=38
Double-blind Study in Paediatric Epileptic to Compare the Subject Preference for ESL Suspension Formulation With Alternative Flavours
Source: ClinicalTrials.gov NCT02021461 ↗Enrolled (actual)
38
Serious AEs
2.6%
Results posted
Apr 2014
Primary outcomePrimary: Assessment of Taste Preference — 5.8; 5.8; 7.1 units on a scale (0-10 cm VAS)
Summary
The purpose of this study is to investigate the taste preference in children of 3 different flavours of the ESL oral suspension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of Taste Preference |
5.8; 5.8; 7.1 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02021461). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.