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

NCT06414044 | Active Not Recruiting DMC

• 1 other identifier: RICe_4
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

Migraine; Migraine With Aura; Migraine Without Aura; Chronic Migraine

Keywords

Headache; Medication overuse headache; Pain; Migraine prevention; Gepant

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (15)

• Changes in migraine frequency across twelve months of atogepant treatment

  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

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

• Evaluation of any adverse event (qualitative)

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

• Evaluation of any adverse event (quantitative)

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

• Evaluation of serious adverse event

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

Other Outcomes (11)

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

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

• Variation of duration of aura (qualitative)

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

• Variation of type of aura (qualitative)

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

Study Arms (2)

Episodic migraine

Patients affected by migraine with an episodic pattern (\< 15 monthly migraine days) with or without aura according to ICHD-III criteria.

Drug: Atogepant 60 mg

Chronic migraine

Patients affected by chronic migraine (\> 15 monthly headache days with at least 8 days with migraine features) according to ICHD-III criteria.

Drug: Atogepant 60 mg

Interventions

Atogepant 60 mg DRUG

Patients using atogepant 60 mg tablet daily as migraine prevention

Chronic migraine; Episodic migraine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi

Florence, 50134, Italy

Location

Fondazione Policlinico Campus Bio-Medico

Roma, 00128, Italy

Location

Related Publications (6)

• 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.

  PMID: 37516125 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.

  PMID: 32822633 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.

  PMID: 34521260 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.

  PMID: 38364831 BACKGROUND

• 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.

  PMID: 41878762 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.

  PMID: 40267275 DERIVED

MeSH Terms

Conditions

Migraine Disorders; Migraine with Aura; Migraine without Aura; Headache; Headache Disorders, Secondary; Pain

Interventions

atogepant

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher at the Headache Center and Clinical Pharmacology Unit and at the Department of Health Sciences, University of Florence, Principal Investigator

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 14, 2024
• Study Start: May 9, 2024
• Primary Completion: November 30, 2025
• Study Completion: April 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

IT (2)