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i-NEED: NEw migrainE Drugs Database

Recruitingn/aAges 18 Years - anyAllIRCCS San Raffaele Roma
NCT07103694 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Approved by the Food and Drug Administration (FDA) and the European Medicine Agency (EMA) starting in 2018, anti-CGRP monoclonal antibodies (anti-CGRP mAbs) represent the first true revolution in the preventive treatment of migraine due to their selectivity and specificity. To date, four anti-CGRP mAbs have been developed for the preventive treatment of migraine: eptinezumab, erenumab, fremanezumab, and galcanezumab.Anti-CGRP mAbs constitute not only the first specific and selective treatment for the prevention of migraine but also the most extensively studied pharmacological category in this field, considering the vast and complex populations examined. The clinical effects of the various mAbs are substantially comparable and are characterized by several fundamental aspects: * High efficacy in both episodic and chronic migraine, with the presence of super-responders who experience a red

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age more or equal 18 years; * Males and females; * Willingness to sign the informed consent; * Episodic migraine for the use of drug indicated for migraine attack * High frequency episodic migraine, at least 8 days per month of disabling migraine in the past 3 months; * Chronic migraine, according to the ICHD-III criteria; Exclusion Criteria: * Other headaches different than migraine; * Known intolerance to the eccipients; * Vascular disease or Raynaud.
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What it tests

  • anti-CGRP monoclonal antibodies
  • gepants
  • combination of sumatriptan and naproxen
  • ditan
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Where

2 sites
Istituto Auxologico Italiano IRCCS
Milan, Italy
IRCCS San Raffaele
Rome, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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