Efficacy and Safety of Eslicarbazepine Acetate (BIA 2093) as Therapy for Patients With Post-herpetic Neuralgia: a Double-blind, Double-dummy, Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 567
- 主要终点
- Change in Mean Pain (NRPS) From Baseline to Endpoint in Mean Pain
研究概览
简要总结
The primary objective of the study is to assess the efficacy of eslicarbazepine acetate (ESL) as therapy for patients with post-herpetic neuralgia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent to participate in the study
- •Men and women aged 18 years or older
- •Previous diagnosis of herpes zoster
- •Diagnosis of postherpetic neuralgia and neuropathic pain present for more than 3 months after healing of the herpes zoster skin rash
- •Cooperation and willingness to complete all aspects of the study
- •Completion of at least 4 daily diaries during the week preceding randomisation
- •A minimum average daily pain score of 4 on the NRPS in the last 4 diary entries before randomisation.
排除标准
- •Pain of other origin that might confound the assessment of neuropathic pain of postherpetic origin
- •Active herpes zoster lesion or dermatitis of any origin at the affected site
- •Subjects who had neurological ablation by block or neurosurgical intervention for control of pain
- •Significant or unstable medical or psychiatric disorders
- •Drug or alcohol abuse in the preceding 2 years
- •Severe renal function impairment, as shown by calculated creatinine clearance values < 30 mL/min at screening
- •Relevant clinical laboratory abnormalities (e.g., Na+ <130 mmol/L, alanine (ALT) or aspartate (AST) transaminases >2.0 times the upper limit of the normal, white blood cell count (WBC) <2,500 cells/mm3)
- •Previous participation in any study with eslicarbazepine acetate
- •Pregnancy or breast feeding
- •History of hypersensitivity to the investigational products or to drugs with a similar chemical structure
- •History of non-compliance
- •Likelihood of requiring treatment during the study period with drugs or other interventions not permitted by the clinical study protocol
- •Participation in a clinical study within 3 months prior to screening
- •Any clinical significant concomitant condition which might influence the assessments or conduct of the trial.
研究组 & 干预措施
ESL 400 mg twice-daily
ESL 400 mg twice-daily
干预措施: Eslicarbazepine acetate (Drug)
ESL 800 mg once-daily
ESL 800 mg once-daily
干预措施: Eslicarbazepine acetate (Drug)
ESL 600 mg twice daily
ESL 600 mg twice daily
干预措施: Eslicarbazepine acetate (Drug)
ESL 1200 mg once daily
ESL 1200 mg once daily
干预措施: Eslicarbazepine acetate (Drug)
ESL 800 mg twice daily
ESL 800 mg twice daily
干预措施: Eslicarbazepine acetate (Drug)
placebo
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Mean Pain (NRPS) From Baseline to Endpoint in Mean Pain
时间窗: baseline and 13 weeks
The primary efficacy variable will be based upon an 11-point (0-10) Numeric Rating Pain Scale (NRPS), where 0 = no pain and 10 = worst possible pain, to be recorded in a patient's diary upon awakening each morning. This score should reflect the patient's mean pain over the previous 24 hours. Please note that the change from baseline to endpoint in mean pain, i.e. the difference between endpoint mean pain and baseline mean pain, which are defined as follows: * Baseline mean pain is defined as the mean of the last four available ratings of average daily pain (NRPS) in the patient diary performed in the last 7 days before randomisation. * Endpoint mean pain is defined as the mean of the last four available ratings of average daily pain in the patient diary in the last 7 days of the treatment period.
次要结局
未报告次要终点