Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Adjunctive Therapy for Refractory Partial Seizures

Completed · Phase 3 · Has a placebo group

Conditions studied: Partial Epilepsy

In brief

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

Key facts

Study ID

NCT00988429

Run by

Bial - Portela C S.A.

People needed

653

Starts

2008-12-02

Expected to finish

2012-01-12

Last updated by the study team

2021-05-19

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Neurology Clinic, P.C. — Northport, Alabama, United States
• 21st Century Neurology - Division of Xenoscience, Inc. — Phoenix, Arizona, United States
• Barrow Neurological Institute / St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• Phoenix Neurological Associates/Clinical Research Advantage — Phoenix, Arizona, United States
• ANI Research, PC — Sun City, Arizona, United States
• University of Arizona Health Sciences Center — Tucson, Arizona, United States
• Arkansas Neurology — Conway, Arkansas, United States
• Clinical Trials Inc. — Little Rock, Arkansas, United States
• Kern County Neurological Medical Group, INC. — Bakersfield, California, United States
• Neuro-Pain Medical Center, Inc. — Fresno, California, United States
• Loma Linda University — Loma Linda, California, United States
• Collaborative Neuroscience Network, INC — Long Beach, California, United States
• Viking Clinical Research Center — Murrieta, California, United States
• Bright Minds Institute — San Francisco, California, United States
• Milestone Clinical Research — San Jose, California, United States
• Neurosearch II, Inc. — Ventura, California, United States
• University of Colorado Health Sciences — Aurora, Colorado, United States
• Denver Health — Denver, Colorado, United States
• Bradenton Research Center — Bradenton, Florida, United States
• Optima Neurological Services, LLC — Gainesville, Florida, United States
• University of Florida Department of Neurology — Gainesville, Florida, United States
• NW FL Clinical Research Group, LLC — Gulf Breeze, Florida, United States
• Palm Springs Research Institute — Hialeah, Florida, United States
• University of Florida — Jacksonville, Florida, United States
• University of South Alabama Department of Neurology — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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