Gepant TreAtments: EffectIveNess and TolERability (GAINER)

Launched by UNIVERSITY OF FLORENCE · Jun 5, 2023

Keywords

ClinConnect Summary

The GAINER clinical trial is studying a medication called rimegepant to see how well it works and how safe it is for people who suffer from migraines, including those with and without aura, as well as chronic migraines. This study is open to adults aged 18 and older who experience at least three migraine days each month. To participate, you'll need to have a diagnosis of migraine according to specific guidelines and must have been keeping a headache diary for at least the previous month.

If you decide to join the trial, you'll be part of a larger group of people across various locations who are also trying this treatment. You'll receive regular check-ins to monitor how well the medication is working for you and to ensure you are tolerating it well. However, please note that some individuals may not be eligible to participate, such as those with certain medical conditions or who are pregnant or breastfeeding. This study aims to provide valuable information that could help improve treatment options for migraine sufferers in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of migraine without aura, migraine with aura, or chronic migraine according to the 3rd edition of the International Classification of Headache Disorder (ICHD-III).
• • At least 3 MMDs
• • Good compliance to study procedures
• • Availability of headache diary at least of the preceding months before enrollment
• Exclusion Criteria:
• • Subjects with contraindications for use of gepants;
• • Concomitant diagnosis of medical diseases and/or comorbidities that, in the Investigator's opinion might interfere with study assessments;
• • medical comorbidities that could interfere with study results;
• • Pregnancy and breastfeeding.