National, Phase III, Multicenter, Randomized, Open, Parallel, to Evaluate the Efficacy, Safety and Superiority of Cefalium® Compared to the Tylenol® in the Treatment of Migraine Attacks

National clinical trials, phase III, randomized, open, parallel, study of superiority, in which three hundred thirty-six (336) participants of both sexes, aged between 18 and 65 years will be randomly allocated to one of two treatment groups. The Group 01 will use Cefalium® and group 02 will use Tylenol®.

开始日期2020-04-01

申办/合作机构

Aché Laboratórios Farmacêuticos SA

100 项与对乙酰氨基酚/咖啡因/甲磺酸双氢麦角胺/盐酸甲氧氯普胺相关的临床结果

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100 项与对乙酰氨基酚/咖啡因/甲磺酸双氢麦角胺/盐酸甲氧氯普胺相关的转化医学

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100 项与对乙酰氨基酚/咖啡因/甲磺酸双氢麦角胺/盐酸甲氧氯普胺相关的专利（医药）

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项与对乙酰氨基酚/咖啡因/甲磺酸双氢麦角胺/盐酸甲氧氯普胺相关的文献（医药）

2018-01-01·Retinal cases & brief reports

CEFALIUM-INDUCED BILATERAL TRANSIENT MYOPIA, RETINAL FOLDS, AND FOCAL CHOROIDAL DELAY

Article

作者: Volkmann, Mathias Alexandre ; Vedana, Gustavo ; Arana, Luís Augusto ; Bach, Mariana Bolzani ; Arana, Jayme

Purpose::

To describe a case of acute bilateral transient myopia, retinal folds, and island of choroidal delay associated with oral administration of Cefalium, a medication commonly prescribed in Brazil for migraine that combines acetaminophen 500 mg, caffeine 40 mg, dihydroergotamine mesylate 1 mg, and metoclopramide hydrochloride 10 mg.

Methods::

A 21-year-old woman with bilateral blurred vision 1 day after the use of Cefalium. The main outcomes measures were BCVA, ocular fundus, ocular coherence tomography, and angiography findings.

Results::

The patient developed bilateral myopia, retinal folds, and focus choroidal delay 1 day after the administration of oral cefalium. Ocular fundus examination and ocular coherence tomography revealed retinal folds in the internal surface of the retina. Angiography showed focus areas of hypofluorescence in both eyes. Seven days after Cefalium was suspended, all clinical symptoms had resolved, with full recovery from the abnormal findings on ocular fundus, ocular coherence tomography, and angiography.

Conclusion::

This is the first report that identified and described bilateral transient myopia, retinal folds, and focus choroidal delay secondary the use of Cefalium.

100 项与对乙酰氨基酚/咖啡因/甲磺酸双氢麦角胺/盐酸甲氧氯普胺相关的药物交易

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