Partial epilepsy MedDRA version: 19.0 Level: LLT Classification code 10065336 Term: Partial epilepsy System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Zebinix
Product Name: eslicarbazepine acetate
Product Code: eslicarbazepine acetate
Pharmaceutical Form: Tablet
INN or Proposed INN: eslicarbazepine acetate
Current Sponsor code: SEP-00020
Sponsors
Sunovion Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subject who completed, exited, or discontinued for reasons other than safety from the 18-week treatment phase of Protocols 093-045 or 093-046 and are willing to continue participation in this study are eligible. Subject must have completed at least the first 3 weeks of the 18-week double-blind treatment period of Protocols 093-045 or 093-046 to be eligible. 2.Subject must give written informed consent prior to participation in the study. For subjects =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1.Subject with serum sodium level =125 mmol/L. 2.Subject with any kind of hypersensitivity (especially manifested as rash) suspected to be induced by eslicarbazepine, carbamazepine, oxcarbazepine, or chemically-related substances. 3.Subject who needs to initiate prohibited concomitant medications. 4.Subject who needs to reduce eslicarbazepine acetate dose to 2400 mg QD. 5.Subject who needs to use >2 additional AEDs. If applicable, provide sufficient study drug to taper subject off of study drug (taper schedule is at the Investigator’s discretion). Schedule a follow-up (unscheduled) visit, if applicable, to assess AEs and to collect all remaining study drug in the original container (including any empty containers). Please also refer to Section 12, Discontinuation and Replacement of Subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): 1.Clinical evaluations (adverse events, vital signs, orthostatic effects, physical and full neurological examination, body weight, and 12-lead ECGs). 2.Clinical laboratory evaluations (serum chemistry, hematology and urinalysis), high-density lipoprotein (HDL)-cholesterol, low density lipoprotein (LDL)-cholesterol, and triglycerides), coagulation testing (PT/INR, and PTT), bone turnover markers (serum 25-hydroxyvitamin D [25-OHD], parathyroid hormone [PTH], osteocalcin, bone-specific alkaline phosphatase, and urinary N-telopeptides of type I collagen cross-links [NTx]). 3.Proportion (%) of subjects with increase of body weight =7%. 4.Proportion (%) of subjects with normal baseline blood sodium reaching levels of =135 mmol/L, =130 mmol/L, and =125 mmol/L. 5.Columbia Suicidality Severity Rating Scale (C-SSRS). 6.Time on eslicarbazepine acetate monotherapy. 7.Seizure frequency reduction from baseline period (Visit 1 to 2) of Protocols 093-045 or 093-046. 8.Responder rate (proportion [%] of subjects with a =50% reduction of seizure frequency from baseline period [Visit 1 to 2] of Protocols 093-045 or 093-046). 9.Proportion (%) of subjects seizure-free during study (determined in 12-week intervals). 10.Seizure frequency by seizure type. 11.Completion rate (proportion [%] of subjects completing the one-year treatment). 12.Treatment retention time (time to withdrawal due to lack of efficacy or adverse events). 13.Change in total score from Visit 2 (Day 0) of Protocols 093-045 or 093-046 to end of study treatment (Visit 7, Month 12) in 31-Item Quality of Life in Epilepsy (QOLIE-31). 14.Change in total score from Visit 2 (Day 0) of Protocols 093-045 or 093-046 to end of study treatment (Visit 7, Month 12) in Montgomery-Asberg Depression Rating Scale (MADRS). 15.Change in total score from Visit 2 (Day 0) of Protocols 093-045 or 093-046 to end of study treatment (Visit 7, Month 12) in MADRS in those subjects with a MADRS score of =14 at screening visit of | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Bulgaria, Canada, Czech Republic, Serbia, Spain, Ukraine, United States
Contacts
Public ContactNicola Bishop
INC Research
Outcome results
None listed