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临床试验/NCT02101892
NCT02101892已完成不适用

Prediction of Migraine Prevention Efficacy: Individualization of Treatment by Coupling Drug's Mode of Action With Patient's Mechanism of Pain Modulation

Rambam Health Care Campus1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2014年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
1
主要终点
predictive value of the pre-treatment pain measures parameter(s) for benefit from amitriptyline treatment

研究概览

简要总结

A major reason for the substantial underuse of pharmacological prevention of migraine is its inadequate efficacy, since only ~50% of patients respond to a specific agent. There is currently no evidence-based way to identify the patients that will respond to a specific preventive treatment. Amitriptyline is one of the commonest agents used for migraine prevention, strengthening patient's pain inhibitory capacity. Individual tailoring of analgesics according to pain inhibitory capacity has been shown effective by our group for painful diabetic neuropathy patients. Specifically, patients with reduced pain inhibition capacity gained more from a drug that augment pain inhibition as compared to those with efficient inhibitory capacity. The investigators now propose to assess migraineurs for their pain inhibition capacity, and examine whether, along similar reasoning, those with reduced inhibitory capacity are the ones more likely to respond to amitriptyline. Psychophysical and neurophysiological dimensions of pain inhibitory modulation will be assessed in migraineurs, who will, subsequently, receive either amitriptyline or placebo for 8 weeks, in a randomized two arms parallel double blind design, and followed up for attacks reduction. The investigators expect to identify the best predictors for efficacy of migraine prevention by the study drug. This approach will promote individualization of migraine therapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •premenopausal
  • •meeting the international headache society criteria for migraine
  • •having >4 attacks or days of migraine/month

排除标准

  • •baseline month diary indicating lower frequency of migraine
  • •chronic migraine (>15 days of headache per month)
  • •use of migraine preventive treatment during previous 3 month
  • •language barrier or cognitive dysfunction

研究组 & 干预措施

Amitriptyline

Active Comparator

Amitriptyline, 25 mg per os, daily, evening, for 8 weeks; starting dose is 12.5 mg for 2 days

干预措施: placebo (Drug)

placebo

Placebo Comparator

sugar pills

干预措施: Amitriptyline (Drug)

结局指标

主要结局

predictive value of the pre-treatment pain measures parameter(s) for benefit from amitriptyline treatment

时间窗: one year

ANCOVA will be utilized, based on factors treatment (amitriptyline or placebo), conditioned pain modulation capabilities (responder or non-responder), their interaction, a number of covariates, to predict reduction attacks.

次要结局

  • predictive value of pain-related psychological parameters for benefit from amitriptyline treatment(one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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