Ultramicronized PEA (Normast) in Spinal Cord Injury Neuropathic Pain: a Randomized, Double-blind, Placebo-controlled, Parallel, Multi-center Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 4
- 主要终点
- Change in mean pain intensity on a 0-10 numerical rating scale from baseline week to last week of treatment
研究概览
简要总结
Randomized, double-blinded, placebo-controlled, parallel group study of ultramicronized PEA (Normast)600 mg x 2 daily or corresponding placebo with a week of baseline period followed by 1 x 12 weeks treatment period.
详细描述
Study design: Randomized, double-blinded, placebo-controlled, parallel, multi-center study of ultramicronized PEA (Normast)with a week of baseline period followed by 1 x 12 weeks treatment period.
Methodology: Given Normast 600mg x 2 daily or corresponding placebo and kept on that dose for 12 weeks.
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
- •Patients aged 18 years or more with at- and/or below-level neuropathic pain for at least 3 months due to trauma or disease of the spinal cord or cauda equina (of at least 6 months old) with a mean pain intensity from 4 to 9 on a 0-10 point numeric rating scale (NRS) during a one-week baseline period will be eligible for the study
排除标准
- •known concomitant severe cerebral damage, terminal illness, planned surgery, pregnancy or lactation, alcohol or substance abuse, hypersensitivity to PEA or carrier, and psychiatric disease except depression.
研究组 & 干预措施
Ultramicronized PEA (Normast)
Normast is ultramicronized Palmitoylethanolamide (PEA) classified as "Dietary foods for special medical purposes".
干预措施: Ultramicronized PEA (Normast) (Dietary Supplement)
Microgranules
Same as Normast, without active component.
干预措施: Ultramicronized PEA (Normast) (Dietary Supplement)
结局指标
主要结局
Change in mean pain intensity on a 0-10 numerical rating scale from baseline week to last week of treatment
时间窗: 12 weeks
次要结局
- Spasticity/spasms and sleep disturbance, change in mean score from baseline to last week of treatment(12 weeks)
- depression(MDI)(12 weeks)
- Global Impression of Change(12 weeks)
- Pain relief of overall pain and at-and below level pain(12 weeks)
- allodynia(touch and cold)(12 weeks)
- anxiety(GAD-10)(12 weeks)
- Spasticity and spasms on a 0-10 NRS(12 weeks)
- effect on unpleasantness(12 weeks)
- Insomnia Severity Index(12 weeks)
- Modified Tardieu and clonus over ankle joints(12 weeks)
- NNT for 33% and 50% pain reduction(12 weeks)
- Health related quality of life S-TOPS(12 weeks)
- Pain symptoms evaluated by NPSI(12 weeks)
- pain impact on activities, sleep and mood(12 weeks)
- escape medication(12 weeks)
- Combined spasticity and pain score (CPSS)(12 weeks)
- Numbers of responders (33% pain reduction) in those with and without allodynia/hyperalgesia and those with different pain symptoms (NPSI)(12 weeks)