None listed
Conditions
Interventions
Intervention1: Eslicarbazepine: 400 mg once daily (OD)for 12 weeks
Control Intervention1: Oxcarbazepine: 300 mg BID (600 mg/day)for 12 weeks
Sponsors
Emcure Pharmaceuticals Ltd., Pune
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and Female subjects between 18 to 65 years of age. 2.Subjects diagnosed with simple or complex partial seizures with or without secondary generalization and taking stable doses of antiepileptic drugs for at least 2 weeks. 3.Subjects with at least 2 partial ? onset seizures per month OR 4 partial ? onset seizure in last 2 months in spite of treatment with following one to two (1-2) antiepileptic drugs: phenytoin, valproic acid, primidone, phenoparbital, lamotrigine, gabapentin, topiramate, clonazepam, carbamazepine and levetiracetam OR any other antiepileptic drugs except Eslicarbazepine/ oxcarbazepine. 4.Subject willing to give written informed consent and willing to comply with trial protocol
Exclusion criteria
Exclusion criteria: 1.Subjects with primary generalized seizure. 2.Subjects with known progressive neurological disorder. 3.Subjects with episode of status epilepticus or cluster seizure within past 3 months. 4.Subjects with seizure of non-epileptic origin. 5.Subjects with major psychiatric illness or previous suicidal attempts. 6.Patients taking concurrent drug therapies with: Monoamine oxidase inhibitor (MAO), Calcium channel blockers (CCB), falbamate, diuretics, desmopressin, warfarrin, nefazodone and oxcarbazepine. 7.Known hypersensitivity to eslicarbazepine, carbamazepine, oxcarbazepine, tricyclic compounds OR known hypersensitivity to any constituent of the Test/ Reference formulation. 8.Subjects with cardiac arrhythmia or any abnormality on ECG. 9.Subjects with previous history of bone marrow depression. 10.Patients with significant hematological / metabolic / endocrinologial (excluding type 2 Diabetes Mellitus) / respiratory/cardiac/liver/kidney/psychiatric diseases 11.Pregnant and lactating mother. 12.Female of reproductive age and willing to become pregnant. 13.Female of reproductive age using steroidal/hormonal contraceptives. 14.Patients who will receive some other drug during the study besides that in the protocol that could alter the pharmacokinetic/ pharmacodynamic profile of the study drug. 15.Patients with Alcohol or drug abuse. 16.Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy variable will be responder rate, defined as subjects with a ≥ 50% reduction in seizure frequencyTimepoint: 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Seizure frequency per 4 weeks 2.Number of days with seizure 3.Proportion of seizure free subjects 4.Proportion of subjects with an exacerbation in seizure frequency (≥ 25%) 5.Distribution of seizure reduction (proportion of subjects with seizure reduction of 50%; ≥ 50 ? 75% or > 75%) 6. Subjects? global assessment for efficacy 7. Physicians? global assessment for efficacy Timepoint: 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks | — |
Countries
India
Contacts
Public ContactDr Sandeep Sonawane
Emcure Pharmaceuticals Ltd.
Outcome results
None listed