Partial epilepsy MedDRA version: 14.1 Level: LLT Classification code 10065336 Term: Partial epilepsy System Organ Class: 10029205 - Nervous system disorders
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: eslicarba
Sponsors
Sunovion Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Diagnosis of partial epilepsy as defined in the Classification of Seizures of the International League Against Epilepsy (ILAE)23 (simple partial seizures with observable motor component, or complex, with or without secondary generalization) a.Medical history of seizures; b.Absence of confounding factors (pseudoseizures, syncope); c.Documented EEG recording (done within 10 years prior to screening) consistent with focal onset epilepsy. 2.Documented CT or MRI scan conducted within 10 years prior to screening, showing the absence of a progressive structural abnormality (eg, tumor). Mesial temporal sclerosis is acceptable. 3.=4 partial onset seizures during the 8 weeks prior screening with no 28-day seizure free period. 4.Stable treatment with 1-2 AEDs during the last 4 weeks prior to screening. General:Subjects are male or female and aged 18-70 years, inclusive. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 169 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1.Subjects with only simple partial seizures without a motor component. 2.Presence of generalized seizure syndromes (eg, juvenile myoclonic epilepsy or Lennox-Gastaut syndrome). 3.History of pseudo-seizures. 4.Current seizures related to an acute medical illness. 5.Seizures secondary to metabolic, toxic or infectious disorder or drug abuse. 6.Status epilepticus within 2 years prior to screening. 7.Seizures only occurring in a cluster pattern. 8.Subjects taking 2 of the following sodium channel blocking AEDs: phenytoin, carbamazepine, oxcarbazepine, or lamotrigine. 9.Subjects taking 2 AEDs with both being in the upper dose range. 10.Subjects taking more than 2 AEDs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of eslicarbazepine acetate monotherapy at a dose of 1600 mg/day in subjects with partial epilepsy not well controlled by current antiepileptic drugs (AED), in comparison to a historical pseudo-placebo control group in accordance with the White Paper on Alternative Monotherapy Design in the Treatment of Epilepsy.;Secondary Objective: To evaluate the efficacy of eslicarbazepine acetate monotherapy at a dose of 1200 mg/day in subjects with partial epilepsy not well controlled by current AEDs. To evaluate the safety of eslicarbazepine acetate monotherapy in subjects with partial epilepsy not well controlled by current AEDs. To evaluate the population pharmacokinetics (PK) of eslicarbazepine acetate monotherapy subjects with partial epilepsy not well controlled by current AEDs.;Primary end point(s): The primary endpoint for the present study is the proportion (%) of subjects meeting at least one of the five exit criteria (see Study Design) over a 16-week study period (from start of AED taper [Visit 4, Week 2 through end of double-blind monotherapy [Visit 9, Week 18]). ;Timepoint(s) of evaluation of this end point: Seizure data will be collected for the subject during the baseline period and seizure rate will be calculated at each visit so that exit criteria can be assessed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate the efficacy of eslicarbazepine acetate monotherapy at a dose of 1200 mg/day in subjects with partial epilepsy not well controlled by current AEDs. To evaluate the safety of eslicarbazepine acetate monotherapy in subjects with partial epilepsy not well controlled by current AEDs. To evaluate the population pharmacokinetics (PK) of eslicarbazepine acetate monotherapy subjects with partial epilepsy not well controlled by current AEDs.;Timepoint(s) of evaluation of this end point: Proportion (%) of subjects that are seizure-free during the 10-week (Weeks 9 through 18) double-blind monotherapy treatment. | — |
Countries
Bulgaria, Canada, Czech Republic, Serbia, Spain, Ukraine, United States
Contacts
Public ContactMarek Perz
INC Research UK Ltd
Outcome results
None listed