Atogepant in Real Life in Italy (GIANT)
- Conditions
- Migraine, Prophylaxis
- Registration Number
- NCT06136442
- Lead Sponsor
- IRCCS San Raffaele Roma
- 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 migraine days) with or without medication overuse.
- 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 12 weeks. Secondary endpoints include: change in monthly analgesic intake, Numeric Rating Scale (NRS), Headache Impact Test-6 (HIT-6) and Migraine disability assessment (MIDAS) scores, \>=50%, \>=75%, 100% responders, \>=50%, \>=75%, 100% responders in patients with medication overuse at weeks 9-12 compared to baseline and adverse events eventually occur during 12 weeks of treatment.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 500
•
Age: >18 yrs Diagnosis of migraine Migraine frequency: >=4 monthly migraine days (MMDs)
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in monthly migraine days at weeks 9-12 compared to baseline 12 weeks variation of number of monthly migraine days
- Secondary Outcome Measures
Name Time Method Change in monthly analgesic intake at weeks 9-12 compared to baseline 12 weeks variation of number of analgesic intake
Change in Numerical Rating Scale (NRS) score at weeks 9-12 compared to baseline 12 weeks variation of Numerical Rating Scale (NRS) score
Change in HIT-6 (Headache Impact Test) score at weeks 9-12 compared to baseline 12 weeks variation of HIT-6
Change in Migraine Disability Assessment Test Score (MIDAS) at weeks 1-12 compared to baseline Change in MIDAS (Migraine Disability Assessment Score) score at weeks 9-12 compared to baseline 12 weeks variation of MIDAS
>50%, >75%, 100% responders at weeks 9-12 compared to baseline 12 weeks proportion of migraine patients who respond to atogepant with reduction of MMDs \>=50%, \>=75% and 100%
>50%, >75%, 100% responders at weeks 9-12 compared to baseline in patients with Medication overuse 12 weeks proportion of migraine patients with medication overuse who respond to atogepant with reduction of MMDs \>=50%, \>=75% and 100%
adverse events 12 weeks adverse events eventually occur during 12 weeks of treatment