Clinical Study to evaluate efficacy and safety of Eslicarbazepine acetate as an adjunctive therapy in partial-onset seizures
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Primary efficacy variable will be responder rate, defined as subjects with a ≥ 50% reduction in seizure frequency
研究概览
简要总结
This is a openlabel, randomized, multi-center, phase III clinical trial conducted to evaluate efficacy and safety of Eslicarbazepine acetate as an adjunctive therapy in partial-onset seizures. A total of 200 patients will be enrolled in the study. All patients will receive either Eslicarbazepine acetate 400 mg tablet or Oxcarbazepine 300 mg tablet. For both the treatment groups, the starting dose will be lower strength. In subsequent visits dose may be titrated, if clinically required. All patients will be evaluated every two weeks for efficacy and safety variables during 3 months of therapy. The primary efficacy variable will be responder rate, defined as subjects with a ≥ 50% reduction in seizure frequency. The secondary efficacy variables will 1) Seizure frequency per 4 weeks; 2) Number of days with seizure; 3) Proportion of seizure free subjects 4) Proportion of patients with an exacerbation in seizure frequency (≥ 25%); 5) Distribution of seizure reduction (proportion of patients with seizure reduction of 50%; ≥ 50 ? 75% or > 75%); 6) Subjects? global assessment for efficacy; 7) Physicians? global assessment for efficacy. The safety variables will be Clinical: 1) Percent of the subjects experiencing any drug related adverse event as evaluated and recorded by the investigator; 2) Subject?s global assessment about the tolerability of the drug; 3) Physician?s global assessment about the tolerability of the drug Investigational: Subjects will be evaluated for CBC (Complete Blood Count), LFT (Liver Function Test), KFT (Kidney Function Test) Lipid profile, FBG (Fasting Blood Glucose), and ECG (Electrocardiogram)
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
入选标准
- •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.
排除标准
- •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.
- •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.
结局指标
主要结局
Primary efficacy variable will be responder rate, defined as subjects with a ≥ 50% reduction in seizure frequency
时间窗: 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks
次要结局
- 1.Seizure frequency per 4 weeks2.Number of days with seizure3.Proportion of seizure free subjects4.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(0, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks)