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Efficacy and Safety of Eslicarbazepine Acetate as Adjunctive Therapy for Refractory Partial Seizures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT00957684
First received: August 10, 2009
Last updated: June 18, 2012
Last verified: June 2012
History of Changes
  Purpose

The primary objective is to evaluate the efficacy of eslicarbazepine acetate once-daily at doses of 400 mg, 800 mg and 1200 mg compared with placebo as adjunctive therapy in patients with refractory partial epilepsy over a 12-week maintenance period. Patients who complete Part I may enter a 1-year open-label extension.


Condition Intervention Phase
Refractory Partial Epilepsy
 Drug: eslicarbazepine acetate
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Adjunctive Therapy for Refractory Partial Seizures in a Double-blind, Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Trial.

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy Seizures
U.S. FDA Resources

Further study details as provided by Bial - Portela C S.A.:

Primary Outcome Measures:
  • Seizure frequency [ Time Frame: 12-week maintenance period ] [ Designated as safety issue: No ]
    The primary efficacy endpoint was seizure frequency over the 12-week maintenance period in Part I of the study, standardised to a "frequency per 4 weeks" unit.


Secondary Outcome Measures:
  • Proportion of patients with a 50% or greater reduction in seizure frequency [ Time Frame: 12-week maintenance ] [ Designated as safety issue: No ]
    The primary efficacy endpoint was seizure frequency over the 12-week maintenance period in Part I of the study, standardised to a "frequency per 4 weeks" unit.

  • Adverse events, [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Number of reported AES/patient


Enrollment: 402
Study Start Date: July 2004
Study Completion Date: November 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ESL 400 mg once daily Drug: eslicarbazepine acetate
once-daily oral tablet
Other Name: Zebinix
Experimental: ESL 800 mg once daily Drug: eslicarbazepine acetate
once-daily oral tablet
Other Name: Zebinix
Experimental: ESL 1200 mg once daily Drug: eslicarbazepine acetate
once-daily oral tablet
Other Name: Zebinix
Placebo Comparator: placebo Drug: placebo
once daily placebo comparator

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • written informed consent signed by patient
  • aged 18 years or more
  • documented diagnosis of simple or complex partial seizures with or without secondary generalisation since at least 12 months prior to screening
  • at least 4 partial seizures in each 4 week period during the last 8 weeks prior to screening, currently treated with 1 or 2 AEDs (any except oxcarbazepine and felbamate), in a stable dose regimen during at least 2 months prior to screening (patients using vigabatrin should have been on this medication for at least 1 year with no deficit in visual field identified)
  • excepting epilepsy, patient is judged to be in general good health based on medical history, physical examination and laboratory tests
  • post-menopausal or otherwise incapable of becoming pregnant by reason of surgery or tubal ligation; in case of woman of childbearing potential, patient must present a serum beta-hCG test consistent with a non-gravid state and agree to remain abstinent or use reliable contraception (oral contraception should be combined with a barrier method)

Exclusion Criteria:

  • only simple partial seizures with no motor symptomatology (classified as A2-4 according to the International Classification of Epileptic Seizures) that are not video-EEG documented
  • primarily generalised epilepsy
  • known rapid progressive neurological disorder; 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 psychogenic origin within the last 2 years
  • history of schizophrenia or suicide attempt
  • currently on or with exposure to felbamate or oxcarbazepine more within one month of screening
  • using benzodiazepines on more than on an occasional basis (except when used chronically as AED)
  • previous use of ESL or participation in a clinical study with ESL
  • known hypersensitivity to carbamazepine, oxcarbazepine or chemically related substances
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00957684

Locations
Germany
Department of Epileptology, Friedrich Wilhelms University Bonn
Bonn, Germany, 53127
Hungary
National Institute of Psychiatry and Neurology, Huvosvolgyi ut 116
Budapest, Hungary, 1021
Sponsors and Collaborators
Bial - Portela C S.A.
Investigators
Principal Investigator: Prof. Christian Elger Department of Epileptology, Friedrich Wilhelms University Bonn
Principal Investigator: Prof. Peter Halasz National Institute of Psychiatry and Neurology, Budapest, Hungary
  More Information

No publications provided

Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT00957684     History of Changes
Other Study ID Numbers: BIA-2093-301
Study First Received: August 10, 2009
Last Updated: June 18, 2012
Health Authority: Portugal: National Pharmacy and Medicines Institute

Keywords provided by Bial - Portela C S.A.:
refractory
partial
epilepsy

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013