A Study of a Drug to be Used in Addition With Another Drug to Treat Adults With Uncontrolled Partial-onset Seizures
Condition: Epilepsy With Partial On-set Seizures
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 4

Summary: 
      A study of a drug to be used in addition with another drug to treat adults with Uncontrolled
      Partial-onset Seizures
    

Detailed description: 
      This is a 31-week, multicenter, 2-arm, prospective, open-label, non-randomized, Phase 4 study
      of eslicarbazepine acetate (ESL) as adjunctive therapy in adult subjects with a diagnosis of
      epilepsy with POS. Two groups of ESL-naïve subjects will be evaluated. The groups are defined
      as follows:

        -  Arm 1 (ESL as first add-on): This group will include subjects who have been maintained
           on a regimen consisting of a stable dose of LEV or LTG for at least 1 month (28 days)
           prior to screening and who have not used any adjunctive treatment.

        -  Arm 2 (ESL as later add-on): This group will include subjects who have been maintained
           on a regimen consisting of a stable dose of 1-2 AEDs (excluding oxcarbazepine [OXC]) for
           at least 1 month (28 days) prior to screening and who have used adjunctive treatment in
           the past.

      The Arm 1 subjects will allow an assessment of the efficacy and safety of ESL in subjects who
      are early in the course of their disease and being treated with one of the most common first
      line AEDs.

      The subjects in Arm 2 are similar to the subject population in the ESL Phase 3 adjunctive
      epilepsy studies, treatment-resistant subjects who are later in the course of their disease.
      The inclusion of these subjects in the present study will provide an assessment of the
      efficacy and safety of ESL as a later adjunctive therapy in a real world clinical setting.

      In addition, this study will provide data from both Arm 1 and Arm 2 for several behavioral,
      mood-related, and QOL-related assessments that were not evaluated in the ESL Phase 3
      adjunctive epilepsy program.

      The study will consist of a Screening Phase of 1 to 2 weeks, followed by a 2-week Titration
      Phase, a 24-week Maintenance Phase, and a Safety Follow-up/Taper Phase of 4 weeks. The last
      visit in the Maintenance Phase (Visit 9) is considered the End of Study (EOS) visit
    

Intervention name(s): Eslicarbazepine acetate; Eslicarbazepine Acetate
Intervention type(s): Drug; Drug
Intervention description(s): eslicarbazepine acetate tablets, taken once daily. Subjects begin 2-week Titration Phase starting on Day 1 (Week 1), by initiating treatment with ESL 400 mg/day. Subjects titrate to minimum dose of 800 mg/day for the 24-week Maintenance Phase beginning at Week 3. In the Maintenance Phase, subjects may titrate in weekly increments of 400 mg/day as medically indicated at the discretion of Investigator up to a maximum dose of 1200 mg/day (Canadian sites) or 1600 mg/day (US sites); eslicarbazepine acetate acetate tablets, taken once daily. Subjects begin 2-week Titration Phase starting on Day 1 (Week 1), by initiating treatment with ESL 400 mg/day. Subjects titrate to minimum dose of 800 mg/day for the 24-week Maintenance Phase beginning at Week 3. In the Maintenance Phase, subjects may titrate in weekly increments of 400 mg/day as medically indicated at the discretion of Investigator up to a maximum dose of 1200 mg/day (Canadian sites) or 1600 mg/day (US sites)
Other intervention name(s): Aptiom; ESL; SEP-0002093; BIA-2-093; Aptiom; ESL; SEP-0002093; BIA-2-093
Intervention MeSH terms: Eslicarbazepine acetate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Arm 1 (ESL as first add-on) Arm 2 (ESL as later add-on)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: epilepsy; seizures; partial on-set seizures