Efficacy and Safety of Eslicarbazepine Acetate as Adjunctive Therapy for Refractory Partial Epilepsy
Condition: Partial Epilepsy
MeSH terms: Epilepsy; Epilepsies, Partial
Intervention: eslicarbazepine acetate; placebo (Part I); ESL - Open-label Extension (Part II)
Intervention description: oral tablet, 800 mg or 1200 mg once daily; once daily placebo comparator; Part II was a 1-year open-label extension for patients who had completed Part I. Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day
Intervention MeSH terms: Eslicarbazepine acetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 253.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: epilepsy

Summary:

      The primary objective was to evaluate the efficacy of eslicarbazepine acetate (ESL)
      administered once daily at 1200 mg or 800 mg, compared with placebo as adjunctive therapy in
      patients with refractory partial epilepsy over a 12-week maintenance period.
    

Eligibility 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