CTRI/2010/091/000100已完成3 期
A Multicenter, Randomized Open-Label, Comparative, Prospective Clinical Trial to Investigate Efficacy and Safety of Eslicarbazepine Acetate Tablet versus Oxcarbazepine SR Tablet as an Adjunctive Treatment in Patients With Refractory Epilepsy Suffering From Partial Onset Seizures With or Without Secondary Generalisation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 210
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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)  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, α1-antagonist and α2-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
研究者
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