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MigraineSTARNCT06414044

Italian Real-life obServational Study on the effecTiveness, sAfety and Tolerability of Atogepant in Migraine Patients

An observational study of Migraine and Migraine With Aura, run by University of Florence at 2 sites in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Atogepant 60 mg
Type of treatment
Pill or oral medicine
How many people
500 participants
Where
2 sitesItaly
Study dates
9 May 2024to Apr 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Multicentric study on patients attending the outpatient clinic of Italian Headache centres who meet criteria for atogepant use for migraine preventive treatment.

Who may be able to join

  • Diagnosis of migraine without aura, migraine with aura, or chronic migraine according to the 3rd edition of the International Classification of Headache Disorder (ICHD-III);
  • At least 3 monthly migraine days;
  • Good compliance to study procedures;
  • Availability of headache diary at least of the preceding months before enrollment.

Who cannot join

  • Subjects with contraindications for use of gepants;
  • Concomitant diagnosis of medical diseases and/or comorbidities that, in the Investigator's opinion might interfere with study assessments;
  • medical comorbidities that could interfere with study results;
  • Pregnancy and breastfeeding.

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

  • SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi

    Florence, 50134

  • Fondazione Policlinico Campus Bio-Medico

    Roma, 00128

Other trials in Italy

About this study

Official title: STudio Osservazionale Sull'Efficacia, Sicurezza e tollerabilità di Atogepant in Pazienti Real Life Affetti da Emicrania in Italia (Studio STAR)

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.

Read the detailed description

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.

Being tested
Atogepant 60 mg
Keywords
Headache, Medication overuse headache, Pain, Migraine prevention, Gepant
Medical subject headings
Migraine Disorders, Migraine with Aura, Migraine without Aura, Headache, Headache Disorders, Secondary, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atogepant 60 mgDrug

    Patients using atogepant 60 mg tablet daily as migraine prevention

Study groups in NCT06414044
Study groupRoleWhat they receive
Episodic migrainePatients affected by migraine with an episodic pattern (< 15 monthly migraine days) with or without aura according to ICHD-III criteria.
Receives: Drug: Atogepant 60 mg
Chronic migrainePatients affected by chronic migraine (> 15 monthly headache days with at least 8 days with migraine features) according to ICHD-III criteria.
Receives: Drug: Atogepant 60 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Baseline (T0) - 3 months of treatment with atogepant (T3)

  2. 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)

    Measured: Baseline (T0) - 3 months of treatment with atogepant (T3)

Secondary outcomes (15)

  1. 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)

    Measured: Baseline (T0) - 6 months (T6) - 12 months (T12) of treatment with atogepant

  2. Percentage of 50% Responders (namely patients who presented a reduction of MMDs >/ = 50% compared to baseline) across twelve months of treatment with atogepant

    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)

    Measured: Baseline (T0) - 6 months (T6) - 12 months (T12) of treatment with atogepant

  3. Evaluation of any adverse event (qualitative)

    Type of any adverse events in patients receiving atogepant during the observation period (categorical variable)

    Measured: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant

  4. Evaluation of any adverse event (quantitative)

    Percentage of reported adverse events in patients receiving atogepant assessed quarterly during the observation period (continuous variable)

    Measured: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant

  5. 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)

    Measured: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant

  6. 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)

    Measured: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant

  7. Consistency of treatment response

    Percentage of patients with a stable 50% response across twelve months of atogepant treatment (continuous variable)

    Measured: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant

  8. 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)

    Measured: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant

  9. 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)

    Measured: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant

  10. 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)

    Measured: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant

  11. 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)

    Measured: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant

  12. 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)

    Measured: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant

  13. 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)

    Measured: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant

  14. 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)

    Measured: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant

  15. 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)

    Measured: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2024
  2. Study start9 May 2024
  3. Primary completion30 Nov 2025
  4. Study completionApr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06414044
Sponsor's protocol ID
RICe_4
Acronym
STAR
Status last verified
Jan 2026
First submitted
10 May 2024
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 37516125

  • 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.

    PubMed 32822633

  • 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.

    PubMed 34521260

  • 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.

    PubMed 38364831

  • 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.

    PubMed 42360082

  • 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.

    PubMed 41878762

  • 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.

    PubMed 40267275

Questions about this trial

What is this clinical trial studying?

An observational study of Migraine and Migraine With Aura, run by University of Florence at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in migraine frequency after three months of treatment (time frame: Baseline (T0) - 3 months of treatment with atogepant (T3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06414044, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.

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