Migraine, Prophylaxis
Conditions
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.
Interventions
DRUGAtogepant
atogepant in real life in Italy
Sponsors
IRCCS San Raffaele Roma
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
• Age: \>18 yrs Diagnosis of migraine Migraine frequency: \>=4 monthly migraine days (MMDs)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in monthly migraine days at weeks 9-12 compared to baseline | 12 weeks | variation of number of monthly migraine days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Change in monthly analgesic intake at weeks 9-12 compared to baseline | 12 weeks | variation of number of analgesic intake |
| >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 |
| >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% |
Contacts
Primary ContactPiero Barbanti
Backup ContactCinzia Aurilia
Outcome results
None listed