Status:
COMPLETED
Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Adjunctive Therapy for Refractory Partial Seizures
Lead Sponsor:
Bial - Portela C S.A.
Collaborating Sponsors:
Sumitomo Pharma America, Inc.
Conditions:
Partial Epilepsy
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether Eslicarbazepine acetate (BIA 2-093) is an effective adjunct therapy in the treatment of refractory partial seizures
Detailed Description
The study was designed to include 3 parts; only the first part is described in this report. Part I of the study was an international, randomized, placebo-controlled, double-blind, parallel group, mult...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- At V1 (screening), patient must be/have:
- Written informed consent signed by patient.
- Aged 16 years or more (patients under 18 years of age require parental/legal representative consent). In North America as well as in other participating countries, when appropriate and/or required by state or local law, minor patients must give written informed assent prior to participation in the study.
- A documented diagnosis of epilepsy since at least 12 months prior to screening.
- At least 4 partial-onset seizures (including subtypes of simple partial, complex partial and partial seizures evolving to secondarily generalised) on the 4 weeks prior to screening.
- Currently treated with 1 or 2 AEDs (any except OXC), in a stable dose regimen during at least 1 month prior to screening. Patients using vigabatrin should have been on this medication for at least 1 year with no deficit in visual field identified (a confirmatory test should be available within 1 month before study entry). The device for VNS should be implanted at least 6 months before screening; parameters need to be stable for at least 1 month prior to screening (VNS will not be counted as concomitant AED).
- Excepting epilepsy, patient is judged to be in general good health based on medical history, physical examination findings, and clinical laboratory test results.
- Post-menopausal or otherwise incapable of becoming pregnant by reason of surgery or tubal ligation. In case of women of childbearing potential (WOCBP), patient must present a serum beta-human chorionic gonadotropin (B-hCG) test consistent with a non gravid state and agree to remain abstinent or use reliable contraception (hormonal contraception should be combined with a barrier method) beginning at screening and continuing at least to the PSV.
- At V2 (randomisation), patient must have:
- At least 8 partial-onset seizures during baseline with at least 3 partial-onset seizures in each 4-week section of the 8-week baseline period prior to randomisation (documented in a diary) and no seizure-free interval exceeding 28 consecutive days.
- In case of WOCBP, patient must present a urine B-hCG test consistent with a non gravid state.
- Diaries satisfactorily completed by the patient or his/her caregiver.
- Satisfactorily complied with the study requirements during the baseline period (including no changes in concomitant AED therapy should have occurred in the baseline period).
- Exclusion Criteria
- At V1 (screening), patients must not be/have:
- Only simple partial seizures with no motor symptomatology (classified as A2 4 according to the International Classification of Epileptic Seizures).
- Primarily generalised seizures.
- Known progressive neurological disorders (progressive brain disease; epilepsy secondary to progressive cerebral lesion).
- Occurrence of seizures too close to count accurately.
- History of status epilepticus or cluster seizures (i.e., 3 or more seizures within 30 minutes) within the 3 months prior to screening.
- Seizures of non-epileptic origin.
- Seizures of psychogenic origin within the last 2 years.
- Major psychiatric disorders.
- Documented diagnosis of schizophrenia with accompanying documented history of at least 1 acute psychosis episode within the last 2 years) or history of suicide attempt.
- Currently treated with OXC.
- Using benzodiazepines on more than an occasional basis (defined as more than 2 times per week), except when used chronically as AED.
- Known exposure to Eslicarbazepine acetate from previous study.
- o Previous use of Eslicarbazepine acetate or participation in a clinical study with Eslicarbazepine acetate (patients not exposed to Eslicarbazepine acetate \[e.g., screen failed\] are allowed).
- Known hypersensitivity to carboxamide derivatives.
- History of abuse of alcohol, drugs or medications within the last 2 years.
- Uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder.
- Second or third-degree atrioventricular blockade not corrected with a pacemaker.
- Relevant clinical laboratory abnormalities (e.g., sodium \<130 mmol/L, alanine or aspartate transaminases \>2.0 times the upper limit of the normal, white blood cell \[WBC\] count \<3,000 cells/mm3) or for patients of Asian ancestry, positive HLA B\*1502 test.
- Estimated creatinine clearance \<60 mL/min \[men: (140-age) x weight/serum creatinine x 72; women: (0.85) (140-age) x weight/serum creatinine x 72. Age in years, weight in kg, and serum creatinine in mg/dL\].
- Pregnant or nursing.
- Participation in other drug clinical trial within the last 2 months or received an investigational drug within 5 half-lives of this other product, whichever is longer. Patient(s) who are known to have not taken any doses of study drug(s) in earlier study(ies) (e.g. screen-failures) are allowed without any time limitation.
- Not ensured capability to perform the trial.
- Any other condition or circumstance that, in the opinion of the Investigator, may compromise the patient's ability to comply with the study protocol.
- Currently treated with VNS, but implanted \<6 months before screening or parameters not stable for at least 1 month prior to screening.
- At V2 (randomisation), patients must not be/have:
- Inadequate compliance to concomitant AEDs during the 8-week baseline period or to screening exclusion criteria.
- Inadequate completion of the study diary.
- Any other condition or circumstance that, in the opinion of the Investigator, may compromise the patient's ability to comply with the study protocol.
Exclusion
Key Trial Info
Start Date :
December 2 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 12 2012
Estimated Enrollment :
653 Patients enrolled
Trial Details
Trial ID
NCT00988429
Start Date
December 2 2008
End Date
January 12 2012
Last Update
May 19 2021
Active Locations (162)
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1
University of South Alabama Department of Neurology
Mobile, Alabama, United States, 36693
2
Neurology Clinic, P.C.
Northport, Alabama, United States, 35476
3
21st Century Neurology - Division of Xenoscience, Inc.
Phoenix, Arizona, United States, 85004
4
Barrow Neurological Institute / St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013