NCT00690716已完成2 期
A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Nasal Carbon Dioxide in the Treatment of Mild Headache in Migraineurs
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Capnia, Inc.
- 入组人数
- 292
- 试验地点
- 1
- 主要终点
- The proportion of patients who are pain-free
研究概览
简要总结
The purpose of this study is to evaluate the safety and effect of nasal carbon dioxide in the treatment of mild headaches in people who have migraines.
详细描述
This multi-center, adaptively randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of a nasal, non-inhaled administration of carbon dioxide (CO2) in the treatment of mild headaches. An estimated 250 patients who meet the eligibility criteria will be enrolled into this study at approximately 15 sites to ensure that about 220 patients are randomized and complete the study.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to read and understand informed consent form and voluntarily consent to participate in this study by signing the IRB-approved informed consent form
- •Established diagnosis of migraine with or without aura per ICHD-II (patients with a diagnosis of only menstrual migraine are not eligible)
- •History of 2-8 migraine attacks per month during the 3 months prior to randomization
- •Have a typical migraine which progresses from a distinct mild headache to a moderate or severe migraine
- •Able to recognize a mild headache that could develop into a moderate or severe migraine
排除标准
- •Have less than 48 hours of freedom from headache between attacks of migraine
- •Have 15 or more headache days per month
- •Are females who are pregnant or lactating
- •Use antipsychotic or antidepressant medications (unless only for migraine prophylaxis) within 12 weeks prior to randomization and for the duration of the study
- •Have a concurrent diagnosis of TMD or trigeminal neuralgia requiring treatment
- •Clinically significant deviated septum, nasal polyps or other nasal condition that prevents unrestricted breathing through each nostril
- •Have participated in another study with nasal CO2
研究组 & 干预措施
1
Experimental
Nasal CO2
干预措施: Nasal CO2 (Drug)
2
Placebo Comparator
Inactive Placebo
干预措施: Inactive Placebo (Drug)
结局指标
主要结局
The proportion of patients who are pain-free
时间窗: 2 hours post study drug administration
次要结局
未报告次要终点
研究者
研究点 (1)
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