Effects of Eslicarbazepine Acetate (Esl, Bia 2-093) on Cognitive Function in Children With Partial Onset Seizures
Condition: Partial Epilepsy
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Intervention: Eslicarbazepine acetate (BIA 2-093); Placebo
Intervention description: Eslicarbazepine acetate (ESL) tablets 200 mg and the matching placebo will be supplied. Treatments will be administered by oral route, once-daily, in the evening. The dose will be rounded to the nearest 100 mg unit. Half tablets may be used for dose adjustment if necessary.; Treatments will be administered by oral route, once-daily, in the evening.
Intervention MeSH terms: Eslicarbazepine acetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 123.0
Sex: All
Minimum age: 6 Years
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Partial Epilepsy; eslicarbazepine acetate; Children

Summary:

      To evaluate the effects of eslicarbazepine acetate on cognition in comparison with placebo as
      adjunctive therapy in children aged 6 to 16 years old with refractory partial-onset seizures.
    

Eligibility criteria:

        Inclusion Criteria:

        At visit 1 (screening), patient must be/have:

          -  written informed consent by parent or legal guardian and, where applicable, the
             patient;

          -  age 6 to 16 years, inclusive;

          -  a documented diagnosis of epilepsy for at least 12 months prior to screening;

          -  at least 2 partial onset seizures during the 4 weeks prior to screening despite
             treatment with 1 to 2 AEDs in a stable dose regimen;

          -  an Intelligence Quotient (IQ) of at least 70;

          -  current treatment with 1 to 2 AEDs (except oxcarbazepine, benzodiazepines other than
             clobazam and vagus nerve stimulation (VNS));

          -  excepting epilepsy, patient is judged to be in general good health based on medical
             history, physical examination and clinical laboratory tests;

          -  in the opinion of the investigator, able to complete the Cognitive Drug Research (CDR)
             test battery;

          -  in case of a girl of childbearing potential, patient presents a serum B-human
             chorionic gonadotropin (B hCG) test consistent with a non gravid state and agrees to
             remain abstinent or use reliable contraception (if used, hormonal contraception must
             be combined with a barrier method) starting at screening and continuing until at least
             the post-study visit (PSV).

        At visit 2 (randomisation), patient must be/have:

          -  at least 2 partial-onset seizures during the 4 week baseline period prior to
             randomisation (documented in a diary);

          -  in case of a girl of childbearing potential, patient presents a urine B-hCG test
             consistent with a non-gravid state;

          -  stable dose regimen of concomitant AEDs during the 4 week baseline period;

          -  diaries satisfactorily completed by the patient or his/her caregiver during the
             baseline period;

          -  satisfactory compliance with the study requirements during the baseline period.

        Exclusion Criteria:

        At visit 1 (screening), patients must not be/have:

          -  only simple partial seizures with no motor symptomatology;

          -  primarily generalised seizures;

          -  known rapidly 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;

          -  Lennox-Gastaut syndrome;

          -  West syndrome;

          -  major psychiatric disorders;

          -  seizures of psychogenic origin within the last 2 years;

          -  history of schizophrenia or suicide attempt;

          -  history of attention deficit disorder or other diseases adversely affecting cognitive
             abilities;

          -  currently treated with oxcarbazepine, benzodiazepines other than clobazam (on a
             routine or chronic basis) and/or VNS;

          -  known hypersensitivity to carboxamide derivatives (oxcarbazepine or carbamazepine);

          -  uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic,
             haematological or oncology disorder;

          -  second or third degree atrioventricular blockade;

          -  relevant clinical laboratory abnormalities;

          -  estimated creatinine clearance (CLCR) <60 mL/min;

          -  pregnancy or nursing;

          -  treatment with eslicarbazepine acetate in any previous study;

          -  participation in other drug clinical trial within the last 2 months;

          -  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.

        At visit 2 (randomisation), patients must not be / have:

        • any condition or circumstance that, in the opinion of the investigator, may compromise
        the patient's ability to comply with the study protocol.