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NCT Number: NCT06414044

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

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Chronic Migraine Headache Headache Disorders Headache Disorders, Primary Headache Disorders, Secondary Migraine Disorders Migraine With Aura Migraine Without Aura Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi, Florence, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Atogepant 60 mg

Drug

Patients using atogepant 60 mg tablet daily as migraine prevention

Primary outcomes

  1. Changes in migraine frequency after three months of treatment

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

    Changes in monthly migraine days after three months of treatment with atogepant compared to baseline (continuous variable)

  2. 50% Response after three months of treatment

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

    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)

Secondary outcomes

  1. Changes in migraine frequency across twelve months of atogepant treatment

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

    Changes in monthly migraine days after six and twelve months of treatment with atogepant compared to baseline (continuous variable)

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

    Time frame: 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) after six and twelve months of treatment with atogepant (continuous variable)

  3. Evaluation of any adverse event (qualitative)

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

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

  4. Evaluation of any adverse event (quantitative)

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

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

  5. Evaluation of serious adverse event

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

    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)

  6. Evaluation of adverse event leading to treatment discontinuation

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

    Percentage of adverse events leading to treatment discontinuation in patients receiving atogepant during the observation period (continuous variable)

  7. Consistency of treatment response

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

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

  8. Changes in migraine disability (MIDAS)

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

    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)

  9. Changes in migraine disability (HIT-6)

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

    Changes in Headache Impact Test-6 questionnaire across treatment (continuous variable, 36-78 scale, higher scores indicates greater disability)

  10. Changes in response to acute migraine treatment (m-TOQ)

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

    Changes in migraine Treatment Optimization Questionnaire across treatment (continuous variable, 0-8 scale, higher score indicates higher acute therapy effectiveness)

  11. Changes in allodynia (ASC-12)

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

    Changes in Allodynia Symptoms Checklist-12 questionnaire across treatment (continuous variable, 0-24 scale, higher score indicates more severe allodynia)

  12. Changes in quality of life across atogepant treatment (MSQ)

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

    Changes in Migraine Specific Quality of life questionnaire across treatment (continuous variable, 0-100 scale, 100 indicates full functionality)

  13. Changes in interictal burden across atogepant treatment (MIBS-4)

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

    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)

  14. Self-reported treatment effectiveness

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

    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)

  15. Percentage of patients with Medication overuse headache reverted during treatment

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

    Percentage of patients with a baseline diagnosis of MOH reverted after 3 - 6 and 12 months of treatment (continuous variable)

Other outcomes

  1. Changes in the number of monthly migraine days with aura (quantitative)

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

    Changes in monthly migraine days with aura across treatment (continuous variable, through headache diary assessment)

  2. Variation of duration of aura (qualitative)

    Time frame: 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)

  3. Variation of type of aura (qualitative)

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

    Changes in type of aura across atogepant treatment (qualitative variable - assessed through headache diary and anamnestic data collection)

  4. MMDs reduction in patients Non-responders to mAbs

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

    Change of monthly migraine days across treatment in those patients who did not respond to anti-CGRP mAbs (continuous variable)

  5. Percentage of 50% Responders across treatment in patients Non-responders to mAbs

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

    Percentage of 50% Responders across treatment in those patients who did not respond to anti-CGRP mAbs (continuous variable)

  6. Menstrually-related migraine

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

    Change in the number of menstrually-related attacks (according to ICHD-3) across treatment compared to baseline (continuous variable)

  7. Change in self-reported effectiveness of treatment

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

    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)

  8. Changes in migraine severity

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

    Changes in migraine severity (continuous variable, 0-10 numerical rating scale, higher scores indicate higher severity)

  9. Changes in migraine duration

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

    Changes in migraine duration (continuous variable- hours- assessed through a paper diary)

  10. Changes in duration of the most bothersome symptom(s)

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

    Changes in duration of the most bothersome symptom(s) across treatment (continuous variable, minutes, assessed through a paper diary)

  11. Changes in severity of the most bothersome symptom(s)

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

    Changes in severity of the most bothersome symptom(s) across treatment (continuous variable: 0-10 scale, higher scores indicate higher severity )

Sponsors and collaborators

Lead sponsor

University of Florence

Other

Collaborators

  • A.O.U. Città della Salute e della Scienza
  • Asst Degli Spedali Civili Di Brescia
  • Auxologico San Luca
  • Azienda Ospedaliera S. Maria della Misericordia
  • Azienda Ospedaliero Universitaria Policlinico Modena
  • Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
  • Azienda Ospedaliero-Universitaria di Parma
  • Azienda Policlinico Umberto I
  • Cliniche Humanitas Gavazzeni
  • Euganea Health Unit, Padua, Italy
  • Fondazione Policlinico Universitario Campus Bio-Medico
  • IRCCS National Neurological Institute "C. Mondino" Foundation
  • Ospedale Santo Stefano
  • Società Italiana per lo Studio delle Cefalee
  • University of Campania Luigi Vanvitelli
  • University of Roma La Sapienza
  • Università degli Studi dell'Aquila

Registry information

Official study title

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

Acronym: STAR

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 14, 2024
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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