Objectives

The authors have previously tried to develop a model for the testing of novel drug candidates for migraine, using the headache and migraine provoking agent cilostazol. Previous studies have used sumatriptan tablets as the validating drug, but they were not sufficiently effective. In this study we test the effect of subcutaneous sumatriptan on cilostazol induced headache in patients with migraine without aura.

Method

Thirty patients with migraine without aura received 200 mg cilostazol on two different study days. The induced headache was treated with subcutaneous sumatriptan in a randomized, double-blind cross-over design. The patients filled out a self-reported headache questionnaire until 12 h after cilostazol.

Results

All 30 patients experienced headache (range 3–10) on both study days and the headache fulfilled the criteria for a migraine-like attack in 73% on the sumatriptan day and in 77% on the placebo day. Sumatriptan injection reduced the headache score 2 h after treatment (p = 0.003). The difference between headache intensity on the sumatriptan day and the placebo day was significant at both 2 h (p = 0.01) and 4 h (p = 0.0007) after treatment.

Conclusion

Subcutaneous sumatriptan reduces cilostazol induced headache in migraine patients. The cilostazol model may be useful as a tool to test the potential of new anti-migraine drugs.

Trial registration: The study is registered on clinicaltrials.gov (NCT03422796).

中文翻译：

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皮下注射舒马曲坦可减轻偏头痛患者的西洛他唑诱发的头痛。

目标

作者之前曾尝试开发一种模型，用于测试偏头痛的新型候选药物，使用头痛和偏头痛诱发剂西洛他唑。以前的研究使用舒马曲坦片剂作为验证药物，但它们的有效性不够。在这项研究中，我们测试了皮下注射舒马曲坦对无先兆偏头痛患者西洛他唑诱发的头痛的影响。

方法

30 名无先兆偏头痛患者在两个不同的研究日接受了 200 毫克西洛他唑。在随机、双盲交叉设计中用皮下注射舒马曲坦治疗诱发的头痛。患者填写自我报告的头痛问卷，直到西洛他唑后 12 小时。

结果

所有 30 名患者在两个研究日均出现头痛（范围 3-10），并且在舒马曲坦日有 73% 的患者和在安慰剂日有 77% 的患者头痛符合偏头痛样发作的标准。注射舒马曲坦降低了治疗后 2 小时的头痛评分（p  = 0.003）。 在治疗后2 小时 ( p  = 0.01) 和 4 小时 ( p = 0.0007) ，舒马曲坦日和安慰剂日头痛强度之间的差异显着。

结论

皮下注射舒马曲坦可减轻偏头痛患者的西洛他唑诱发的头痛。西洛他唑模型可用作测试新型抗偏头痛药物潜力的工具。

试验注册：该研究在clinicaltrials.gov (NCT03422796) 上注册。