A Clinical Trial to Investigate Efficacy and Safety of Eslicarbazepine Acetate Tablet versus Oxcarbazepine SR Tablet Eslicarbazepine as an Adjunctive Treatment in Patients With Refractory Epilepsy Suffering From Partial Onset Seizures With or Without Secondary Generalisation

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2010
INTERVENTION: Intervention1: Eslicarbazepine Acetate: 400mg for one week, then after 800mg for next three weeks, then after based on response up to 1200mg upon investigator's judgment up to 12 weeks. Control Intervention1: Oxcarbazepine Extended Release: 600mg for one week, then after 900mg for next three weeks, then after based on response up to 1200mg upon investigator's judgment up to 12 weeks. CONDITION: Refractory Epilepsy Suffering From Partial Onset Seizures With or Without Secondary Generalisation PRIMARY OUTCOME: Median percentage reduction in frequency of seizures compared to baseline‐‐‐‐‐‐Timepoint: Seizure frequency every four weekly. Comparision between end of trail and base line seizure frequency SECONDARY OUTCOME: Responder Rate (defined as proportion of patients with a minimum of 50% reduction in seizure frequency from baseline) ; Number of seizure‐free patients during the treatment period; Change in QOLIE‐31 score ; Physician?s and patient?s global assessment to the treatment ; ‐‐‐‐‐‐Timepoint: Based on seizure frency reduction INCLUSION CRITERIA: Male and female patients between 18 and 65 years of age (both inclusive) with Refractory Epilepsy Suffering From Partial Onset Seizures With or Without Secondary Generalisation and maintaining a stable dose regimen of at least one Anti‐epileptic drug (AED) or maximum 3 AED for one month up to screening Patients with documented history of at least 1 seizure in last one month. Patients willing to give written informed consent.
Epistemonikos ID: b674efc86ed52bf95b0be5af47688c0dac39d1af
First added on: Aug 22, 2024