Phase 3
N=304
Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children
Partial Epilepsy in Children and Adolescents
Bottom Line
View on ClinicalTrials.gov: NCT00988156 ↗Enrolled (actual)
304
Serious AEs
9.1%
Results posted
Jul 2014
Primary outcome: Primary: Change From Baseline in Seizure Frequency — 62.0; 36.6 seizures/month — p=0.2490
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Eslicarbazepine acetate (BIA 2-093) (Drug); Eslicarbazepine acetate (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Bial - Portela C S.A.
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Seizure Frequency |
62.0; 36.6 | 0.2490 |
| PRIMARY Responder Rate |
40; 41 | 0.9017 |
Summary
The purpose of this study is to examine the efficacy and safety of Eslicarbazepine acetate (BIA 2-093) when given with other anti-epileptic drugs to treat children with partial seizures whose condition has not been controlled by other drug treatments.
Eligibility Criteria
Inclusion Criteria
- girls of child-bearing potential have to follow reliable and medically acceptable contraceptive method throughout the study
- diagnosis of epilepsy for at least 6 months prior to enrolment
- at least 4 partial-onset seizures in the last month prior to enrolment despite stable therapy with adequate dosage of 1 or 2 AEDs
- at least 4 partial-onset seizures during each 4-week interval of the 8-week baseline period
- previous treatment with three or more AEDs, in their maximum tolerated doses, for at least one month, without seizure control
- current treatment with 1 or 2 AEDs (any except oxcarbazepine); if present, vagus nerve stimulation is considered an AED
- stable dose regimen of AEDs during the 8-week baseline period
- cooperation and willingness to complete all aspects of the study, including hospitalisation if required
- written informed consent to participate in the study in accordance with local legislation
Exclusion Criteria
- primarily generalised seizures
- baseline seizure frequency substantially different from usual seizure frequency
- known progressive neurological disorders
- history of status epilepticus within the 3 months prior to enrolment
- seizures of non-epileptic origin
- Lennon-Gastaut
- West syndrome
- Major psychiatric disorders
- Previous treatment any study with Eslicarbazepine acetate
Data sourced from ClinicalTrials.gov (NCT00988156). 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.