Clinical trial NCT06414044: Italian Real-life obServational Study on the effecTiveness, sAfety and Tolerability of Atogepant in Migraine Patients
Official title: STudio Osservazionale Sull'Efficacia, Sicurezza e tollerabilità di Atogepant in Pazienti Real Life Affetti da Emicrania in Italia (Studio STAR)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Migraine
Migraine With Aura
Migraine Without Aura
Chronic Migraine
Keywords: Headache
Medication overuse headache
Pain
Migraine prevention
Gepant
Lead sponsor: University of Florence
Sponsor class: OTHER
Collaborators: name: Fondazione Policlinico Universitario Campus Bio-Medico
name: IRCCS National Neurological Institute "C. Mondino" Foundation
name: Società Italiana per lo Studio delle Cefalee
name: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
name: Università degli Studi dell'Aquila
name: University of Roma La Sapienza
name: Azienda Ospedaliero Universitaria Policlinico Modena
name: Euganea Health Unit, Padua, Italy
name: Azienda Ospedaliero-Universitaria di Parma
name: Azienda Ospedaliera S. Maria della Misericordia
name: A.O.U. Città della Salute e della Scienza
name: Cliniche Humanitas Gavazzeni
name: University of Campania Luigi Vanvitelli
name: Ospedale Santo Stefano
name: Azienda Policlinico Umberto I
name: Auxologico San Luca
name: Asst Degli Spedali Civili Di Brescia
First posted: 2024-05-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multicentric study on patients attending the outpatient clinic of Italian Headache centres who meet criteria for atogepant use for migraine preventive treatment.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in migraine frequency after three months of treatment
timeFrame: Baseline (T0) - 3 months of treatment with atogepant (T3)
measure: 50% Response after three months of treatment
timeFrame: Baseline (T0) - 3 months of treatment with atogepant (T3)
Secondary outcomes:
measure: Changes in migraine frequency across twelve months of atogepant treatment
timeFrame: Baseline (T0) - 6 months (T6) - 12 months (T12) of treatment with atogepant
measure: Percentage of 50% Responders (namely patients who presented a reduction of MMDs >/ = 50% compared to baseline) across twelve months of treatment with atogepant
timeFrame: Baseline (T0) - 6 months (T6) - 12 months (T12) of treatment with atogepant
measure: Evaluation of any adverse event (qualitative)
timeFrame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
measure: Evaluation of any adverse event (quantitative)
timeFrame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
measure: Evaluation of serious adverse event
timeFrame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
measure: Evaluation of adverse event leading to treatment discontinuation
timeFrame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
measure: Consistency of treatment response
timeFrame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
measure: Changes in migraine disability (MIDAS)
timeFrame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
measure: Changes in migraine disability (HIT-6)
timeFrame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
measure: Changes in response to acute migraine treatment (m-TOQ)
timeFrame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
measure: Changes in allodynia (ASC-12)
timeFrame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
measure: Changes in quality of life across atogepant treatment (MSQ)
timeFrame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
measure: Changes in interictal burden across atogepant treatment (MIBS-4)
timeFrame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
measure: Self-reported treatment effectiveness
timeFrame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
measure: Percentage of patients with Medication overuse headache reverted during treatment
timeFrame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
Other outcomes:
measure: Changes in the number of monthly migraine days with aura (quantitative)
timeFrame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
measure: Variation of duration of aura (qualitative)
timeFrame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
measure: Variation of type of aura (qualitative)
timeFrame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
measure: MMDs reduction in patients Non-responders to mAbs
timeFrame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
measure: Percentage of 50% Responders across treatment in patients Non-responders to mAbs
timeFrame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
measure: Menstrually-related migraine
timeFrame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
measure: Change in self-reported effectiveness of treatment
timeFrame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
measure: Changes in migraine severity
timeFrame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
measure: Changes in migraine duration
timeFrame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
measure: Changes in duration of the most bothersome symptom(s)
timeFrame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
measure: Changes in severity of the most bothersome symptom(s)
timeFrame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
Locations:
city: Florence
country: Italy
facility: SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi
city: Roma
country: Italy
facility: Fondazione Policlinico Campus Bio-Medico
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.