A Phase IIa, Randomized, Double-blind, Placebo-controlled, Two-period Cross-over Study Evaluating the Safety, Tolerability and Efficacy of V158866 in Central Neuropathic Pain Following Spinal Cord Injury
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Mean Pain Intensity (NRS)
研究概览
简要总结
The purpose of this study is to investigate whether V158866 is safe and effective for the treatment of neuropathic pain due to spinal cord injury.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18 - 65 years
- •documented spinal cord injury at or below T5
- •moderate pain at or below the level of the spinal cord injury for at least 3 months
- •compliant with daily diary
- •stable pain scores on the NRS
- •mean pain intensity of at least 4 and not more than 9 on the NRS (or if the mean NRS score is >9, the mean Gracely score must be ≤19)
排除标准
- •women of child-bearing potential
- •men who intend to father a child
- •a history of multiple drug allergies, hypersensitivity to any cannabinoid
- •an increased risk of seizure
- •evidence of depression and/or a score of >19 on the BDI-II
- •suicidal ideation or suicidal behavior in the past 10 years
- •a history of substance abuse or dependence within the past year, excluding nicotine and caffeine
- •a positive urine test for cannabis at screening
- •taking excluded medications that cannot be stopped
- •a positive pregnancy test
研究组 & 干预措施
Placebo followed by V158866
Placebo once per day for 4 weeks followed by V158866 450mg once per day for 4 weeks
干预措施: V158866 (Drug)
Placebo followed by V158866
Placebo once per day for 4 weeks followed by V158866 450mg once per day for 4 weeks
干预措施: Placebo (Drug)
V158866 followed by Placebo
V158866 450mg once per day for 4 Weeks followed by Placebo once per day for 4 Weeks
干预措施: V158866 (Drug)
V158866 followed by Placebo
V158866 450mg once per day for 4 Weeks followed by Placebo once per day for 4 Weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Pain Intensity (NRS)
时间窗: 4 Weeks
Numerical Rating Scale, measuring the intensity of pain from 0 to 10, with 0 being no pain and 10 being worst pain imaginable. The comparison of the overall pain intensity, calculated as the mean of the last 7 days on treatment, for each treatment period (V158866 compared to placebo).
Safety and Tolerability of V158866 Compared to Placebo
时间窗: 4 weeks
Safety and tolerability were measured by occurrence of treatment-emergent adverse events; data represents the number of subjects who experienced treatment-emergent adverse events during each treatment period.
次要结局
未报告次要终点
研究者
Christine N. Sang, MD, MPH
Dr Christine Sang
Brigham and Women's Hospital