A Randomized, Multicenter, Double-blind, Placebo-controlled, Cross-over Study of the Efficacy and Safety of BMS-954561 in Patients With Post-herpetic Neuralgia (PHN)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 20
- 主要终点
- The primary endpoint of this study is the average pain score for BMS-954561 vs. placebo.
研究概览
简要总结
The purpose of the study is to evaluate the efficacy of study drug (BMS-954561) as compared to placebo in the treatment of patients with post-herpetic neuralgia (PHN).
详细描述
Allocation: Randomized Stratified
Interventional model: Cross-over Placebo Controlled
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with Post-Herpetic Neuralgia (PHN) as defined as pain present for more than 6 months after the onset of a herpes zoster skin rash affecting the trigeminal, cervical, thoracic, lumbar, or sacral regions.
- •Based on patient diary information collected during the Baseline week (day -7 to randomization Day 1), patient has completed at least 5 diary entries and has an average weekly pain rating of at least 4 on the 11-point pain rating scale.
- •The patient is able to satisfactorily complete, in the Investigator's judgment, the Cognitive Battery.
- •Male or female, 18-85 years of age.
排除标准
- •Other severe pain that may potentially confound pain assessment.
- •History of complete lack of response to pregabalin (at least 300 mg qd for 4 weeks) or gabapentin (at least 1800 mg qd for 4 weeks).
- •Hemoglobin A1c > 9%
- •Hemoglobin ≤ 9 g/dL.
- •Active herpes zoster or known viral infection.
- •Previous neurolytic or neurosurgical therapy for PHN.
- •Estimated glomerular filtration rate (eGFR) according to the re-expressed abbreviated (four-variable) Modification of Diet in Renal Disease (MDRD) Study equation ≤ 40ml/min/1.73m
- •Patients who have been on a stable dose of anticonvulsant,anticholinergic, antiviral medications, nicotine replacements, or any other smoking cessation medications for <4 weeks prior to randomization. Patients who are on stable doses for => 4 weeks prior to randomization are allowed, however, there should be no adjustments to the dose of these medications during study.
- •Patients currently on more than one drug for treatment of neuropathic pain (low dose opioids, antidepressants, or anticonvulsants). Patients are allowed to participate if on a stable dose for at least 4 weeks prior to randomization (Day1) and should remain stable during course of study.
研究组 & 干预措施
Arm 1 BMS-954561 40mg or 80mg
Arm description: BMS-954561 40mg or 80mg three times daily (TID) to Placebo OR Placebo to 40mg or 80mg TID.
Arm type: Active to Placebo or Placebo to Active (cross-over)
干预措施: BMS-954561 (Drug)
Arm 1 BMS-954561 40mg or 80mg
Arm description: BMS-954561 40mg or 80mg three times daily (TID) to Placebo OR Placebo to 40mg or 80mg TID.
Arm type: Active to Placebo or Placebo to Active (cross-over)
干预措施: Placebo (Drug)
Arm 2 BMS-954561 150mg or 300mg
Arm description: BMS-954561 150mg or 300mg TID to Placebo OR Placebo to 150mg or 300mg TID
Arm type: Active to Placebo or Placebo to Active(cross-over)
干预措施: BMS-954561 (Drug)
Arm 2 BMS-954561 150mg or 300mg
Arm description: BMS-954561 150mg or 300mg TID to Placebo OR Placebo to 150mg or 300mg TID
Arm type: Active to Placebo or Placebo to Active(cross-over)
干预措施: Placebo (Drug)
结局指标
主要结局
The primary endpoint of this study is the average pain score for BMS-954561 vs. placebo.
时间窗: up to 10 weeks
次要结局
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).(Open-Label Phase: Weeks 20)
- Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.(Open-Label Phase: Weeks 20)
- Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.(Open-Label Phase: Weeks 20)