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 Generalisatio

Phase 3

Completed

• Registration Number: CTRI/2010/091/000100
• Lead Sponsor: Torrent Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 210

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Responder Rate (defined as proportion of patients with a minimum of 50% reduction in seizure frequency from baseline) <br>Number of seizure-free patients during the treatment period<br>Change in QOLIE-31 score <br>Physician?s and patient?s global assessment to the treatment <br>Timepoint: Based on seizure frency reduction