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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atogepant | Drug | atogepant in real life in Italy |
| Measure | Description | Time Frame |
|---|---|---|
| Change in monthly migraine days at weeks 9-12 compared to baseline | variation of number of monthly migraine days | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in monthly analgesic intake at weeks 9-12 compared to baseline | variation of number of analgesic intake | 12 weeks |
| Change in Numerical Rating Scale (NRS) score at weeks 9-12 compared to baseline |
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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
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migraine patients with >=4 monthly migraine days (MMDs)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Piero Barbanti | Contact | +393357071457 | piero.barbanti@sanraffaele.it | |
| Cinzia Aurilia | Contact | +393334147390 | cinzia.aurilia@sanraffaele.it |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32822633 | Result | Goadsby PJ, Dodick DW, Ailani J, Trugman JM, Finnegan M, Lu K, Szegedi A. Safety, tolerability, and efficacy of orally administered atogepant for the prevention of episodic migraine in adults: a double-blind, randomised phase 2b/3 trial. Lancet Neurol. 2020 Sep;19(9):727-737. doi: 10.1016/S1474-4422(20)30234-9. | |
| 33142014 | Result |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C000718987 | atogepant |
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variation of Numerical Rating Scale (NRS) score
| 12 weeks |
| Change in HIT-6 (Headache Impact Test) score at weeks 9-12 compared to baseline | variation of HIT-6 | 12 weeks |
| 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 | variation of MIDAS | 12 weeks |
| >50%, >75%, 100% responders at weeks 9-12 compared to baseline | proportion of migraine patients who respond to atogepant with reduction of MMDs >=50%, >=75% and 100% | 12 weeks |
| >50%, >75%, 100% responders at weeks 9-12 compared to baseline in patients with Medication overuse | proportion of migraine patients with medication overuse who respond to atogepant with reduction of MMDs >=50%, >=75% and 100% | 12 weeks |
| adverse events | adverse events eventually occur during 12 weeks of treatment | 12 weeks |
| Min KC, Kraft WK, Bondiskey P, Colon-Gonzalez F, Liu W, Xu J, Panebianco D, Mixson L, Dockendorf MF, Matthews CZ, Boinpally R. Atogepant Is Not Associated With Clinically Meaningful Alanine Aminotransferase Elevations in Healthy Adults. Clin Transl Sci. 2021 Mar;14(2):599-605. doi: 10.1111/cts.12917. Epub 2020 Nov 24. |
| 34407343 | Result | Ailani J, Lipton RB, Goadsby PJ, Guo H, Miceli R, Severt L, Finnegan M, Trugman JM; ADVANCE Study Group. Atogepant for the Preventive Treatment of Migraine. N Engl J Med. 2021 Aug 19;385(8):695-706. doi: 10.1056/NEJMoa2035908. |
| 41620660 | Derived | Barbanti P, Egeo G, Doretti A, Pistoia F, Rinalduzzi S, Strumia S, Aurilia C, Scatena P, Autunno M, Salerno A, Galli A, Altavilla R, Messina S, Zanferrari C, Bruno P, Camarda C, D'Onofrio F, Iovene V, Ranieri A, Bono F, de Souza JS, Carnevale A, Di Clemente L, Zucco M, Bandettini Di Poggio ML, Vinciguerra L, Borrello L, Fiorentini G, Vecchio R, Drago V, Torelli P, Albanese M, Tomino C, Bonassi S, Porreca A; Italian Migraine Registry (I-GRAINE) study group. Responders and super-responders to atogepant after 24 weeks of treatment in migraine: real-world evidence from the GIANT-2 study. J Headache Pain. 2026 Jan 31;27(1):68. doi: 10.1186/s10194-026-02277-3. |
| D009422 | Nervous System Diseases |