NCT02784847Unknown早期 1 期
A Pilot Trial of Triheptanoin for the Preventive Treatment of Migraine
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 10
- 主要终点
- Change in monthly migraine days
研究概览
简要总结
A pilot trial of triheptanoin, a natural compound able to promote anaplerotic mitochondrial metabolism, for the preventative treatment of migraine.
详细描述
To test the ability of a daily 3-month treatment with triheptanoin to prevent migraine attacks in 10 migraine patients.
This is an open, non-randomized pilot trial that might justify a placebo-controlled trial, if there are at least 50% of patients with ≥50% reduction in attack frequency.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females aged 18-65 years old having an effective contraception or being menopaused
- •Diagnosis of migraine without aura (ICHD3beta 1.1) since at least 2 years
- •4-10 migraine days per month during the last 3 months
- •No preventive anti-migraine therapy during the last month
排除标准
- •> 4 tension-type headache episodes per month
- •Medication overuse headache or other headache types
- •Resistance to >3 previous preventive anti-migraine drug treatments
- •Any serious medical or psychiatric condition
- •On-going or previous bowel disorder
研究组 & 干预措施
treatment arm
Other
pilot-study with single arm of 10 migraine patients treated for 3 months with triheptanoin 1mg/kg/day
干预措施: Triheptanoin (Drug)
结局指标
主要结局
Change in monthly migraine days
时间窗: Between the 1-month baseline and the 3rd month of triheptanoin treatment
次要结局
- Change in mean attack duration(Between the 1-month baseline and the 3rd month of triheptanoin treatment)
- Change in mean attack severity(Between the 1-month baseline and the 3rd month of triheptanoin treatment)
- Number of patients who have at least a 50% reduction in monthly migraine days(Between the 1-month baseline and the 3rd month of triheptanoin treatment)
研究者
Jean Schoenen
Honorary Professor
University of Liege
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