The effect of fremanezumab on pain in patients with Complex Regional Pain Syndrome: a randomized, double-blind, proof of concept, placebo-controlled trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Difference between groups (placebo vs. active treatment) in the change in self-reported daily ratings of mean average daily pain intensity (ADP) in the affected limb from the baseline week to the last week of treatment, as experienced during the past 24 hours, rated on a 0–10-point numeric rating scale (NRS; 0 = no pain, 10 = worst possible pain).
研究概览
简要总结
The main objective is to compare the change in pain intensity from baseline to last week of fremanezumab treatment to placebo treatment in patients with CRPS.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years.
- •Confirmed CRPS (type I or II) diagnosed according to the International Association of Pain (IASP) diagnostic criteria of CRPS (Budapest criteria) with adaption to research
- •Disease lasting from 3-36 months
- •Mean ADP score of at least 4 on a 11-point NRS scale ranging from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable during the baseline week
- •Written informed consent.
排除标准
- •Other causes of pain and/or inflammation in the same area as CRPS or other concomitant pain/inflammation that cannot be distinguished from CRPS.
- •Significant severe disease
- •Spreading of the CRPS to other extremities according to IASP criteria for spreading of CRPS
- •Initiation of new pain medication or corticosteroids.
- •Poor compliance or patients who cannot cooperate or are unable to be able to complete the project and language difficulties.
- •Severe depression or other significant psychiatric disease, alcohol or drug abuse.
- •Pregnancy or lactation.
- •Women of child-bearing potential unless they use an acceptable effective contraception measure during the study and at least 6 months after or their male partner is vasectomized and their sole partner.
- •Known allergy to any component of fremanezumab.
- •Planned surgery.
研究组 & 干预措施
-
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Difference between groups (placebo vs. active treatment) in the change in self-reported daily ratings of mean average daily pain intensity (ADP) in the affected limb from the baseline week to the last week of treatment, as experienced during the past 24 hours, rated on a 0–10-point numeric rating scale (NRS; 0 = no pain, 10 = worst possible pain).
Difference between groups (placebo vs. active treatment) in the change in self-reported daily ratings of mean average daily pain intensity (ADP) in the affected limb from the baseline week to the last week of treatment, as experienced during the past 24 hours, rated on a 0–10-point numeric rating scale (NRS; 0 = no pain, 10 = worst possible pain).
次要结局
- Difference in Pain relief on a 6-point scale: complete, good, moderate, mild, none, worse.
- Difference in the change in mean CRPS severity score (CSS) from end of baseline to end of week 4 and 8.
- Differences in the area and intensity of mechanical allodynia, assessed by brushing a soft brush (Somedic) twice with a speed of 1-2 cm/s
- The relationship between the primary outcome measure and the duration of CRPS (measured in months).
研究者
Sandra Sif Gylfadottir
Scientific
Aarhus University Hospital