Effect of Minocycline on Neuropathic Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
The purpose of this study is to determine if minocycline is effective in the treatment of neuropathic pain. The effect of minocycline will be compared to the effect of placebo and amitriptyline.
详细描述
Neuropathic pain is pain caused by damage to the central or peripheral nervous system. To date, therapy consists of tricyclic antidepressants (such as amitriptyline) or anticonvulsants. However, results are disappointing. Minocycline, a FDA-approved second generation tetracycline, was efficacious in various animal models of neuropathic pain. We want to study the effect of minocycline in neuropathic pain in humans. The type of neuropathic pain we want to investigate is lumbar radicular pain since this is the most prevalent condition associated with neuropathic pain in humans.
This placebo-controlled randomized double blind trial consists of 3 arms:
- Placebo, once daily by mouth during 14 days.
- Amitriptyline 25mg, once daily by mouth during 14 days.
- Minocycline 100mg, once daily by mouth during 14 days.
Patients can take rescue medication if necessary: tramadol 50mg by mouths up to 3-times daily.
Brain-derived neurotrophic factor is implicated in the generation and maintenance of neuropathic pain in different animal models of neuropathic pain. To study the role of brain-derived neurotrophic factor in neuropathic pain in humans, we will determine its concentration in serum and plasma before and after 14 days medication intake.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Lumbar radicular pain due to disc herniation, failed back surgery syndrome or spinal canal stenosis causing neuropathic pain
排除标准
- •Diabetic, alcoholic or drug induced polyneuropathies
- •Depression or psychiatric comorbidity affecting pain sensation.
- •Use of antidepressants
- •Fibromyalgia and Chronic Fatigue Syndrome
- •Previous spinal cord damage
- •Malignancies
- •Allergy to minocycline or amitriptyline
研究组 & 干预措施
Minocycline
Minocycline 100mg, once daily
干预措施: Minocycline (Drug)
Placebo
Placebo, once daily
干预措施: placebo (Drug)
Amitriptyline
Amitriptyline 25mg, once daily
干预措施: Amitriptyline (Drug)
结局指标
主要结局
Pain intensity
时间窗: Baseline (before start of study), 7 and 14 days after start of medication intake
Pain intensity will be measured using a visual analogue scale and the change in pain intensity between baseline and day 7, day 7 and day 14, baseline and day 14 will be evaluated
次要结局
- neuropathic pain diagnostic questionnaire (DN4) score(Baseline (before start of study), 7 and 14 days after medication intake)
- Amount of rescue medication taken(7 and 14 days after medication intake)
研究者
Pascal Vanelderen
Principal Investigator
Ziekenhuis Oost-Limburg