Migraine Clinical Trial
Official title:
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®.
Cefalium® is a combination of Caffeine + Paracetamol + dihydroergotamine mesylate + metoclopramide hydrochloride. The dihydroergotamine mesylate interacts with the serotonergic, dopaminergic and noradrenergic receptors, but it's mechanism is not totally known. The caffeine presents mechanisms that are not totally clear, but it may relieves the pain by activating of the central noradenosine pathway (pain suppressing system). The Metoclopramide hydrochloride presents an anti-emetic action and prokinetic action in the gastrointestinal tract.One of its properties is the inhibition of nausea and vomiting triggered by drugs such as ergotamine.Paracetamol, also called acetaminophen is an effective agent analgesic and antipyretic with weak anti-inflammatory activity. ;
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