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| Name | Class |
|---|---|
| Fondazione Policlinico Universitario Campus Bio-Medico | OTHER |
| IRCCS National Neurological Institute "C. Mondino" Foundation | OTHER |
| Società Italiana per lo Studio delle Cefalee | OTHER |
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The purpose of this prospective and multicentric study is to evaluate the effectiveness and tolerability of atogepant as preventive migraine treatment in a cohort of episodic or chronic migraine patients.
Atogepant is a small molecule calcitonin gene- related peptide (CGRP) receptor antagonist, part of the gepants family. It is a second generation gepant, currently approved for the preventive treatment of episodic and chronic migraine.
Previously randomized, placebo-controlled phase 2/3 trials demonstrated its effectiveness and tolerability in the preventive setting for patients with episodic and chronic migraine, associated with a good tolerability profile.
The most commonly reported adverse events were upper respiratory tract infections, urinary infections, nausea and constipation.
In this prospective multicentric study the investigators aim to evaluate atogepant effectiveness and tolerability as preventive migraine treatment in a real-world setting. Subjects who meet the inclusion criteria will be enrolled and will participate in the study. Baseline demographic and clinical data will be collected at the baseline.
patients will take atogepant 60 mg daily for at least 12 weeks up to two years, according to effectiveness, tolerability and eventual approval of reimbursability criteria.
Data will be collected at baseline and every three months for two years. Subjects will be asked to keep a headache diary to collect monthly headache and migraine days, migraine severity, associated symptoms and drug consumption. Questionnaires will be collected every three months.
Data collection will focus on: i) demographic data, ii) migraine history, iii) pain intensity, iv) presence and evolution of migraine associated symptoms and aura, v) migraine associated disability, vi) tolerability and eventual treatment- emergent adverse events, vii) treatment persistence. The online database REDCap will be used for data collection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Episodic migraine | Patients affected by migraine with an episodic pattern (< 15 monthly migraine days) with or without aura according to ICHD-III criteria. |
| |
| Chronic migraine | Patients affected by chronic migraine (> 15 monthly headache days with at least 8 days with migraine features) according to ICHD-III criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atogepant 60 mg | Drug | Patients using atogepant 60 mg tablet daily as migraine prevention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in migraine frequency after three months of treatment | Changes in monthly migraine days after three months of treatment with atogepant compared to baseline (continuous variable) | Baseline (T0) - 3 months of treatment with atogepant (T3) |
| 50% Response after three months of treatment | Percentage of 50% Responders (namely patients who presented a reduction of MMDs >/ = 50% compared to baseline) after three months of treatment with atogepant (continuous variable) | Baseline (T0) - 3 months of treatment with atogepant (T3) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in migraine frequency across twelve months of atogepant treatment | Changes in monthly migraine days after six and twelve months of treatment with atogepant compared to baseline (continuous variable) | Baseline (T0) - 6 months (T6) - 12 months (T12) of treatment with atogepant |
| Percentage of 50% Responders (namely patients who presented a reduction of MMDs >/ = 50% compared to baseline) across twelve months of treatment with atogepant |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the number of monthly migraine days with aura (quantitative) | Changes in monthly migraine days with aura across treatment (continuous variable, through headache diary assessment) | Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant |
| Variation of duration of aura (qualitative) |
Inclusion Criteria:
Exclusion Criteria:
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Multicentric study on patients attending the outpatient clinic of Italian Headache centres who meet criteria for atogepant use for migraine preventive treatment.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi | Florence | 50134 | Italy | |||
| Fondazione Policlinico Campus Bio-Medico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37516125 | Background | Pozo-Rosich P, Ailani J, Ashina M, Goadsby PJ, Lipton RB, Reuter U, Guo H, Schwefel B, Lu K, Boinpally R, Miceli R, De Abreu Ferreira R, McCusker E, Yu SY, Severt L, Finnegan M, Trugman JM. Atogepant for the preventive treatment of chronic migraine (PROGRESS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 Sep 2;402(10404):775-785. doi: 10.1016/S0140-6736(23)01049-8. Epub 2023 Jul 26. | |
| 32822633 |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D020325 | Migraine with Aura |
| D020326 | Migraine without Aura |
| D006261 | Headache |
| D051271 | Headache Disorders, Secondary |
| D010146 | Pain |
| 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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| Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari | OTHER |
| Università degli Studi dell'Aquila | OTHER |
| University of Roma La Sapienza | OTHER |
| Azienda Ospedaliero Universitaria Policlinico Modena | OTHER |
| Euganea Health Unit, Padua, Italy | UNKNOWN |
| Azienda Ospedaliero-Universitaria di Parma | OTHER |
| Azienda Ospedaliera S. Maria della Misericordia | OTHER |
| A.O.U. Città della Salute e della Scienza | OTHER |
| Cliniche Humanitas Gavazzeni | OTHER |
| University of Campania Luigi Vanvitelli | OTHER |
| Ospedale Santo Stefano | OTHER |
| Azienda Policlinico Umberto I | OTHER |
| Auxologico San Luca | OTHER |
| Asst Degli Spedali Civili Di Brescia | OTHER |
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Percentage of 50% Responders (namely patients who presented a reduction of MMDs >/ = 50% compared to baseline) after six and twelve months of treatment with atogepant (continuous variable) |
| Baseline (T0) - 6 months (T6) - 12 months (T12) of treatment with atogepant |
| Evaluation of any adverse event (qualitative) | Type of any adverse events in patients receiving atogepant during the observation period (categorical variable) | Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant |
| Evaluation of any adverse event (quantitative) | Percentage of reported adverse events in patients receiving atogepant assessed quarterly during the observation period (continuous variable) | Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant |
| Evaluation of serious adverse event | Percentage of serious adverse events (namely those resulting in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect) in patients receiving atogepant during the observation period (continuous variable) | Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant |
| Evaluation of adverse event leading to treatment discontinuation | Percentage of adverse events leading to treatment discontinuation in patients receiving atogepant during the observation period (continuous variable) | Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant |
| Consistency of treatment response | Percentage of patients with a stable 50% response across twelve months of atogepant treatment (continuous variable) | Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant |
| Changes in migraine disability (MIDAS) | Changes in MIgraine Disability ASsement questionnaire across treatment (continuous variable, 0-270 scale, higher scores indicate higher disability: 0-5, little/no disability; 6-10, mild disability; 11-20, moderate disability; >20, severe disability) | Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant |
| Changes in migraine disability (HIT-6) | Changes in Headache Impact Test-6 questionnaire across treatment (continuous variable, 36-78 scale, higher scores indicates greater disability) | Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant |
| Changes in response to acute migraine treatment (m-TOQ) | Changes in migraine Treatment Optimization Questionnaire across treatment (continuous variable, 0-8 scale, higher score indicates higher acute therapy effectiveness) | Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant |
| Changes in allodynia (ASC-12) | Changes in Allodynia Symptoms Checklist-12 questionnaire across treatment (continuous variable, 0-24 scale, higher score indicates more severe allodynia) | Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant |
| Changes in quality of life across atogepant treatment (MSQ) | Changes in Migraine Specific Quality of life questionnaire across treatment (continuous variable, 0-100 scale, 100 indicates full functionality) | Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant |
| Changes in interictal burden across atogepant treatment (MIBS-4) | Changes in Migraine Interictal Burden Scale-4 questionnaire across treatment (continuous variable, 0-4 scale, 0 indicates no interictal burden, 1-2 mild level of interictal burden, 3 moderate interictal burden, 4 severe interictal burden) | Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant |
| Self-reported treatment effectiveness | Changes in Migraine Assessment of Current Therapy (Migraine-ACT) a 4-item questionnaire about treatment effectiveness and daily life repercussions, across treatment compared to baseline (continuous variable, 0-4 scale, higher scores indicates higher acute treatment effectiveness) | Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant |
| Percentage of patients with Medication overuse headache reverted during treatment | Percentage of patients with a baseline diagnosis of MOH reverted after 3 - 6 and 12 months of treatment (continuous variable) | Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant |
Changes in duration of aura across atogepant treatment (continuous variable - minutes, assessed through headache diary) |
| Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant |
| Variation of type of aura (qualitative) | Changes in type of aura across atogepant treatment (qualitative variable - assessed through headache diary and anamnestic data collection) | Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant |
| MMDs reduction in patients Non-responders to mAbs | Change of monthly migraine days across treatment in those patients who did not respond to anti-CGRP mAbs (continuous variable) | Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant |
| Percentage of 50% Responders across treatment in patients Non-responders to mAbs | Percentage of 50% Responders across treatment in those patients who did not respond to anti-CGRP mAbs (continuous variable) | Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant |
| Menstrually-related migraine | Change in the number of menstrually-related attacks (according to ICHD-3) across treatment compared to baseline (continuous variable) | Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant |
| Change in self-reported effectiveness of treatment | Change in Patients Global Impression of Change (PGIC) questionnaire across treatment (continuous variable, scale 0-7, 1 very much improved, 2 much improved, 3 minimally improved, 4 no change, 5 minimally worse, 6 much worse, 7 very much worse) | Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant |
| Changes in migraine severity | Changes in migraine severity (continuous variable, 0-10 numerical rating scale, higher scores indicate higher severity) | Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant |
| Changes in migraine duration | Changes in migraine duration (continuous variable- hours- assessed through a paper diary) | Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant |
| Changes in duration of the most bothersome symptom(s) | Changes in duration of the most bothersome symptom(s) across treatment (continuous variable, minutes, assessed through a paper diary) | Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant |
| Changes in severity of the most bothersome symptom(s) | Changes in severity of the most bothersome symptom(s) across treatment (continuous variable: 0-10 scale, higher scores indicate higher severity ) | Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant |
| Roma |
| 00128 |
| Italy |
| Background |
| 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. |
| 34521260 | Background | Schwedt TJ, Lipton RB, Ailani J, Silberstein SD, Tassorelli C, Guo H, Lu K, Dabruzzo B, Miceli R, Severt L, Finnegan M, Trugman JM. Time course of efficacy of atogepant for the preventive treatment of migraine: Results from the randomized, double-blind ADVANCE trial. Cephalalgia. 2022 Jan;42(1):3-11. doi: 10.1177/03331024211042385. Epub 2021 Sep 14. |
| 38364831 | Background | Tassorelli C, Nagy K, Pozo-Rosich P, Lanteri-Minet M, Sacco S, Nezadal T, Guo H, De Abreu Ferreira R, Forero G, Trugman JM. Safety and efficacy of atogepant for the preventive treatment of episodic migraine in adults for whom conventional oral preventive treatments have failed (ELEVATE): a randomised, placebo-controlled, phase 3b trial. Lancet Neurol. 2024 Apr;23(4):382-392. doi: 10.1016/S1474-4422(24)00025-5. Epub 2024 Feb 13. |
| 42360082 | Derived | Altamura C, Iannone LF, Castro FL, Sebastianelli G, Marcosano M, Santis F, Corrado M, Ornello R, Grazzi L, Montisano DA, Cesaris F, Munafo A, Avino G, Trimboli M, Albanese M, Russo A, Silvestro M, Volta GD, Romozzi M, Calabresi P, Boccalini A, Merlo P, Prudenzano MP, Valente MR, Rainero I, Giuliani G, Altieri M, Fofi L, Doretti A, Vaghi G, Pistoia F, Ferrandi D, Battistini S, Coppola G, Guerzoni S, Sacco S, Tassorelli C, Vernieri F; Italian Headache Registry (RICe) Study Group. SafeTy and effectiveness of Atogepant accoRding to the IHS outcome categories: A multicentric, prospective observational study in real life (the 24-week STAR study). Cephalalgia. 2026 Jun;46(6):3331024261435922. doi: 10.1177/03331024261435922. Epub 2026 Jun 26. |
| 41878762 | Derived | Iannone LF, Sebastianelli G, Santis F, Corrado M, Marcosano M, Ornello R, Grazzi L, Montisano DA, Cesaris F, Munafo A, Vigani G, Avino G, Trimboli M, Albanese M, Russo A, Volta GD, Romozzi M, Calabresi P, Castro FL, Boccalini A, Merlo P, Prudenzano MP, Valente MR, Rainero I, Giuliani G, Altieri M, Fofi L, Doretti A, Vaghi G, Pistoia F, Lanni C, Ferrandi D, Rufa A, Battistini S, Coppola G, Geppetti P, Sacco S, Guerzoni S, Altamura C, Vernieri F; Italian Headache Registry (RICe) Study Group. The chronopharmacology of atogepant in migraine prevention: A real-world evaluation of influence of timing of administration on effectiveness and tolerability. Cephalalgia. 2026 Mar;46(3):3331024261416490. doi: 10.1177/03331024261416490. Epub 2026 Mar 25. |
| 40267275 | Derived | Vernieri F, Iannone LF, Lo Castro F, Sebastianelli G, De Santis F, Corrado M, Marcosano M, Ornello R, Grazzi L, Montisano DA, De Cesaris F, Munafo A, Fofi L, Doretti A, Vaghi G, Pistoia F, Ferrandi D, Battistini S, Sacco S, Guerzoni S, Altamura C; Italian Headache Registry (RICe) Study Group. Effectiveness and tolerability of atogepant in the prevention of migraine: A real life, prospective, multicentric study (the STAR study). Cephalalgia. 2025 Apr;45(4):3331024251335927. doi: 10.1177/03331024251335927. Epub 2025 Apr 23. |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |