None listed
Conditions
Interventions
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.
Sponsors
Torrent Pharmaceuticals Limited
Eligibility
Inclusion criteria
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.
Exclusion criteria
Exclusion criteria: Patients with seizures occurring in clusters Patients with Status Epilepticus within 3 months of enrolment Patients with history of non-epileptic seizures Patient with simple partial seizure without a motor component Patient with Primary generalised epilepsy. Patients with known allergic reaction or intolerance to study drugs and/or excipients or Carbamezepine or Oxcarbazepine Patients with liver enzymes (ALT and AST) more than 2.5X the normal value and/or bilirubin more than 1.5X the normal value Relevant clinical laboratory abnormalities (e.g. Na+ <130 mmol/L, WBC count <3,000 cells/mm3) Creatinine clearance (CLCR) &#61603; 60 ml/min. History of drug abuse and alcohol abuse with last 2 years. Patients taking felbamate, vigabatrin, topiramate, psychotropic drugs, anticholinergic drugs, anti-parkinson medication, &#945;1-antagonist and &#945;2-antagonist. Patient taking Oxcarbazepine tablets as monotherapy or add on therapy. Intake of sodium lowering medications eg. Diuretics Patients with progressive neurological disorders like multiple sclerosis, Guillain-Barre syndrome Presence of significant cardiac dysfunction or clinically important ECG abnormalities Patients with serious psychiatric disorders like Schizophrenia, Bipolar disorder with suicidal tendencies Use of neuroleptics, MOA inhibitors, barbiturates, or narcotic analgesics within 28 days prior to screening Patients who have participated in any other drug trial within the four weeks preceding study entry Women patient of childbearing potential, not practicing medically acceptable (non-hormonal) method of contraception Pregnant or lactating women, children and adolescents below 18 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median percentage reduction in frequency of seizures compared to baselineTimepoint: Seizure frequency every four weekly. Comparision between end of trail and base line seizure frequency | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactMs. Sweety Shah
General Manager
Outcome results
None listed