Guidelines for New Migraine Clinical Trial

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Researchers and investigators from the International Headache Society have generated novel suggestions for the conduct of preventive and acute migraine clinical trials. HIS Journal Cephalagia presents the third edition of guidelines related to Migraine Clinical trials. This Journal was published by SAGE.

According to the Migraine Trust Organization, “migraine is the most common neurological condition in the developed world.  It is more prevalent than diabetes, epilepsy and asthma combined – eight million people in the UK have migraine.” The World Health Organization also reports that “among adults of all ages, migraine is one of the top 20 causes of disability expressed as years of healthy life lost to disability.”

An expert consensus summary is represented by the new guidelines and these also recommend a standardized, contemporary and evidence based approach to the researchers. These new guidelines are helpful for the researchers since they are involved in conducting, reporting randomized clinical trials of controlled migraine. Clinical research regarding migraine has augmented exponentially from the time when the last set of guidelines was published. Pharmaceutical companies and clinical researchers have accumulated additional experience and now the trend is towards the big, multi-centre and multi-national studies. Seeing these developments, it was important to update the new guidelines.

The IHS lays emphasis that it approves adherence to the novel guidelines until there is scientific validation to diverge from them. They symbolize parameters of research practice and they are at an elevated level in the hierarchy of recommendations based on evidences in the non attendance of printed principles of research practice. The trials for the preventive and acute migraine are focused in the first section of the novel guidelines which is pursued by additional recommendations and discussions which are related to the clinical trials for the migraine prevention. Sub sections of the guidelines include the trial design, patient selection, evaluation of statistics and results.

At the end of guidelines, there is a toolbox for each kind of trail. These guidelines do not encompass wider discussions of the clinical trials ethical considerations and methodologies which were printed elsewhere also. Presently, independence from pain as the initial measure of treatment effectiveness is given much importance in the clinical trials today. The current and updated guidelines are imperative readings for those involved actively with the research of migraine. Many more will be beneficial since more than 10% of the world’s populace suffers from migraine.



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