Status:
NOT_YET_RECRUITING
Atogepant in Real Life in Italy (GIANT)
Lead Sponsor:
IRCCS San Raffaele Roma
Conditions:
Migraine, Prophylaxis
Eligibility:
All Genders
18-100 years
Brief Summary
Atogepant is an oral, small-molecule, calcitonin gene-related peptide (CGRP) receptor antagonist that has been approved for the preventive treatment of episodic and chronic migraine (\>= 4 monthly mig...
Detailed Description
This study is designed to confirm the effectiveness and safety of atogepant in real life. The primary endpoint is the change from baseline in the mean number of monthly migraine days (MMDs)across the ...
Eligibility Criteria
Inclusion
- •
- Age: \>18 yrs Diagnosis of migraine Migraine frequency: \>=4 monthly migraine days (MMDs)
Exclusion
- Patients using concomitant migraine prophylaxis Use of onabotulinumtoxinA during the previous 12 weeks Exposure to anti-CGRP mAbs during the previous 24 weeks Clinically significant cardiovascular disorders
Key Trial Info
Start Date :
April 9 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06136442
Start Date
April 9 2024
End Date
December 31 2024
Last Update
April 10 2024
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