A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of E2007 in Patients With Painful Diabetic Neuropathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- Change in Average Pain Scores From Baseline to Week 15/End of Treatment (EOT)
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of Perampanel in patients with painful diabetic neuropathy.
详细描述
This is a randomized, double-blind, placebo-controlled, parallel-group study. This is a 5-arm, 21-week study comprised of up to a 2-week Screening period, a 15-week Dose-Escalation and Maintenance Phase using 4 doses of E2007 (2 mg, 4 mg, 6 mg, and 8 mg) or placebo, and a 4-week, single-blind placebo Follow-Up Phase. Patients will be randomly assigned to one of the five treatment groups. Those patients assigned to receive either 4 mg, 6 mg, or 8 mg E2007 will be escalated to the appropriate dose according to an escalation schedule. All patients will take four identical-looking tablets on a daily basis for the entire study duration for blinding purposes.
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
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Perampanel 2mg
干预措施: E2007 (2 mg) (Drug)
Perampanel 4mg
干预措施: E2007 (4 mg) (Drug)
Perampanel 6mg
干预措施: E2007 (6 mg) (Drug)
Perampanel 8mg
干预措施: E2007 (8 mg) (Drug)
结局指标
主要结局
Change in Average Pain Scores From Baseline to Week 15/End of Treatment (EOT)
时间窗: Baseline to Week 15/EOT
Average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified baseline observation carried forward (BOCF).
Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 30% Reduction in Pain Score
时间窗: Baseline to Week 15/EOT
Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified BOCF.
Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 50% Reduction in Pain Score
时间窗: Baseline to Week 15/EOT
Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified BOCF.
Mean Change in Average Pain Scores From Baseline at Each Study Week
时间窗: Baseline, Week 1 to Week 17
Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). Last on-treatment value refers to last 7 days of available diary data while subject was on double-blind study drug.
次要结局
- Change in Average Sleep Interference Scores From Baseline to Week 15/EOT(Baseline to Week 15/EOT)
- Change in Short Form - McGill Pain Questionnaire (SF-MPQ) From Baseline to Week 15/EOT(Baseline and Week 15/EOT)
- Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT(Week 15/EOT)
- Change From Baseline to Week 15/EOT in SF-36 Physical and Mental Component Scores(Baseline and Week 15/EOT)
- Change From Baseline to Week 15/EOT in Hospital Anxiety and Depression Scale (HADS) Anxiety and Depression Subscale Scores(Baseline and Week 15/EOT)
- Withdrawal Due to Treatment Failure During Double-Blind Dosing Period(Baseline and Week 15)
- Presence or Absence of Allodynia at Week 15/EOT(Week 15/EOT)
- Analysis of Rescue Analgesic Medication Use (Acetaminophen) During Double-Blind Dosing Period(Baseline to Week 15)