Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Partial Epilepsy in Children and Adolescents |
Drug: Eslicarbazepine acetate (BIA 2-093) Drug: Eslicarbazepine acetate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Efficacy and Safety Study of Eslicarbazepine Acetate (BIA 2 093) as Adjunctive Therapy for Refractory Partial Seizures in Children |
- To assess the efficacy of Eslicarbazepine acetate as adjunctive therapy in children and adolescents with refractory partial seizures [ Time Frame: 34 weeks ] [ Designated as safety issue: No ]
- To assess the safety and tolerability of Eslicarbazepine acetate as adjunctive therapy in children and adolescents with refractory partial seizures [ Time Frame: 34 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 252 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | October 2013 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Eslicarbazepine acetate
To receive Eslicarbazepine acetate in addition to concomitant therapy
|
Drug: Eslicarbazepine acetate (BIA 2-093)
Part I - 8-week observational baseline period followed by a 6-week double-blind titration period, a 12-week double-blind maintenance period, a double-blind tapering-off period, and a 4-week observational period. The recommended target dose of double-blind study treatment will be 20mg/kg/day. Part II: At the end of part I, there is an option to enter a long-term open-label extension period to receive Eslicarbazepine acetate for 1 year. Other Name: BIA 2093
|
|
Placebo Comparator: Placebo
To receive placebo in addition to concomitant therapy
|
Drug: Eslicarbazepine acetate
Part I: 8-week observational baseline period followed by a 6-week double-blind titration period, a 12-week double-blind maintenance period, a double-blind tapering-off period, and a 4-week observational period. Part II: At the end of part I, there is an option to enter a long-term open-label extension period to receive Eslicarbazepine acetate for 1 year. Other Name: BIA 2093
|
Detailed Description:
Partial epilepsy, the commonest form of epilepsy, is a difficult condition to treat with many patients continuing to have symptoms despite trying several medications. Lack of efficacy and adverse effects are commonly associated with current anti-epileptic drugs.
This study will examine the efficacy in addition to safety and tolerability of a new anti-epileptic drug, Eslicarbazepine acetate (BIA 2-093), as an adjunctive therapy for refractory partial seizures in children.
The primary analysis variables are:
- The responder rate (the proportion of patients with at least a 50% reduction in standardised seizure frequency)
- The relative reduction in standardised seizure frequency
Eligibility| Ages Eligible for Study: | 2 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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No publications provided
| Responsible Party: | Bial - Portela C S.A. |
| ClinicalTrials.gov Identifier: | NCT00988156 History of Changes |
| Other Study ID Numbers: | BIA-2093-305 |
| Study First Received: | October 1, 2009 |
| Last Updated: | April 11, 2013 |
| Health Authority: | Portugal: National Pharmacy and Medicines Institute |
Keywords provided by Bial - Portela C S.A.:
|
Epilepsy Partial Refractory Children Adolescents |
Adjunctive Randomised Double-blind Placebo-controlled Parallel-group |
Additional relevant MeSH terms:
|
Epilepsy Epilepsies, Partial Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013