A Safety and Efficacy Study of AGN-214868 in Patients With Postherpetic Neuralgia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Allergan
- 入组人数
- 280
- 试验地点
- 68
- 主要终点
- Change From Baseline in Average Pain Intensity Score - Cohort 1
研究概览
简要总结
This is a safety and efficacy study of AGN-214868 in patients with postherpetic neuralgia (PHN).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Postherpetic neuralgia with pain present for at least 9 months
排除标准
- •Active herpes zoster skin rash
- •Anticipated treatment for postherpetic neuralgia during the first 3 months of the study, including oral and topical medications, acupuncture, spinal cord stimulation, transcutaneous nerve stimulation (TNS), or trigger point injection
- •Anticipated treatment with pain medication for the treatment of postherpetic neuralgia during the first 3 months of the study
- •Use of capsaicin treatment for postherpetic neuralgia within 6 months, or anticipated use during the first 3 months of the study
- •Use of botulinum toxin of any serotype for any reason within 6 months, or anticipated use during the study
研究组 & 干预措施
AGN-214868 Dose 1
AGN-214868 Dose 1 given as injections into the area of pain on Day 1.
干预措施: AGN-214868 (Drug)
AGN-214868 Dose 2
AGN-214868 Dose 2 given as injections into the area of pain on Day 1.
干预措施: AGN-214868 (Drug)
AGN-214868 Placebo (Vehicle)
AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1.
干预措施: AGN-214868 Placebo (Vehicle) (Drug)
AGN-214868 Dose 3
AGN-214868 Dose 3 given as injections into the area of pain on Day 1.
干预措施: AGN-214868 (Drug)
结局指标
主要结局
Change From Baseline in Average Pain Intensity Score - Cohort 1
时间窗: Baseline to Week 12
The average pain intensity score at each week was the mean of the daily average pain intensity scores reported in the patient's eDiary during each 7-day period, starting with the day of study treatment injection. Patients used the 11-point Likert scale, with anchors at 0 = "no pain" and 10 = "pain as bad as you can imagine" Baseline was defined as the mean of the daily average pain intensity scores reported during the baseline period for the 7 days immediately prior to the treatment.
Change From Baseline in Average Pain Intensity Score - Cohort 2
时间窗: Baseline to Week 12
The average pain intensity score at each week was the mean of the daily average pain intensity scores reported in the patient's eDiary during each 7-day period, starting with the day of study treatment injection. patients used the 11-point Likert scale, with anchors at 0 = "no pain" and 10 = "pain as bad as you can imagine" Baseline was defined as the mean of the daily average pain intensity scores reported during the baseline period for the 7 days immediately prior to the treatment.
次要结局
- Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 1(Baseline to Week 1)
- Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 3(Baseline to Week 3)
- Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 4(Baseline to Week 4)
- Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 2(Baseline to Week 2)
- Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 9(Baseline to Week 9)
- Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 2(Baseline to Week 2)
- Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 4(Baseline to Week 4)
- Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 5(Baseline to Week 5)
- Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 6(Baseline to Week 6)
- Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 7(Baseline to Week 7)
- Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 8(Baseline to Week 8)
- Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 10(Baseline to Week 10)
- Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 1(Baseline to Week 1)
- Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 3(Baseline to Week 3)
- Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 11(Baseline to Week 11)
- Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 12(Baseline to Week 12)
- Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 12(Baseline to Week 12)
- Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 2(Baseline to Week 2)
- Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 4(Baseline to Week 4)
- Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 5(Baseline to Week 5)
- Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 6(Baseline to Week 6)
- Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 7(Baseline to Week 7)
- Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 8(Baseline to Week 8)
- Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 9(Baseline to Week 9)
- Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 10(Baseline to Week 10)
- Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 11(Baseline to Week 11)
- Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 12(Baseline to Week 12)
- Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 8(Baseline to Week 8)
- Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 12(Baseline to Week 12)
- Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 2(Baseline to Week 2)
- Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 4(Baseline to Week 4)
- Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 8(Baseline to Week 8)
- Change From Baseline in Area of Allodynia - Cohort 2 - Week 8(Baseline to Week 8)
- Change From Baseline in Area of Allodynia - Cohort 2 - Week 12(Baseline to Week 12)
- Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 2(Baseline to Week 2)
- Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 8(Baseline to Week 8)
- Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 12(Baseline to Week 12)
- Change From Baseline in Area of Allodynia - Cohort 1 - Week 2(Baseline to Week 2)
- Change From Baseline in Area of Allodynia - Cohort 1 - Week 4(Baseline to Week 4)
- Change From Baseline in Area of Allodynia - Cohort 1 - Week 8(Baseline to Week 8)
- Change From Baseline in Area of Allodynia - Cohort 1 - Week 12(Baseline to Week 12)
- Change From Baseline in Area of Allodynia - Cohort 2 - Week 2(Baseline to Week 2)
- Change From Baseline in Area of Allodynia - Cohort 2 - Week 4(Baseline to Week 4)
- Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 4(Baseline to Week 4)
- Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 8(Baseline to Week 8)
- Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 4(Baseline to Week 4)
- Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 12(Baseline to Week 12)
- Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 2(Baseline to Week 2)