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临床试验/NCT00850421
NCT00850421终止不适用

A Single-Center Pharmacoeconomic Pilot Study of BOTOX® (Botulinum Toxin Type A) for the Prophylactic Treatment of Migraine Headaches

HealthPartners Institute1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2004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
终止
入组人数
35
试验地点
1
主要终点
To Determine Whether Resource Utilization is Decreased in Subjects Treated With BOTOX Injections for Episodic Migraine Headache.

研究概览

简要总结

The purposes of this study are to assess whether subjects treated with BOTOX will:

  1. have a decrease in the frequency and intensity of migraine headaches
  2. experience improvements in quality of life
  3. experience a reduction in the frequency of health care services obtained.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects > 18 years of age
  • Subject has an established history of migraine headache, with or without aura, per IHS criteria (1.2.1 or 1.1), for at least 6 months prior to screening.
  • Subject receives primary health care from Park Nicollet Health Services.

排除标准

  • Subject has received previous injections of botulinum toxin of any serotype for any reason, within the 6 months prior to study participation.
  • Additional eligibility will be discussed at point of contact

研究组 & 干预措施

Botulinum Toxin Type A

Other

干预措施: Botulinum Toxin Type A (Drug)

结局指标

主要结局

To Determine Whether Resource Utilization is Decreased in Subjects Treated With BOTOX Injections for Episodic Migraine Headache.

时间窗: 190 days

次要结局

  • To Assess the Effect of BOTX Injections on the Frequency and Intensity of Migraine Episodes in Subjects With Episodic Migraine Headache.(190 days)
  • To Determine Whether Quality of Life is Improved in Subjects Treated With BOTOX Injections for Episodic Migraine Headache.(190 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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