Atogepant in Real Life in Italy (GIANT) (GIANT)

Atogepant in Real Life in Italy

Atogepant is an oral, small-molecule, calcitonin gene-related peptide (CGRP) receptor antagonist that has been approved for the preventive treatment of episodic and chronic migraine (>= 4 monthly migraine days) with or without medication overuse.

Study Overview

• Status: Not yet recruiting
• Conditions: Migraine, Prophylaxis
• Intervention / Treatment: Drug: Atogepant

Detailed Description

This study is designed to confirm the effectiveness and safety of atogepant in real life. The primary endpoint is the change from baseline in the mean number of monthly migraine days (MMDs)across the 12 weeks. Secondary endpoints include: change in monthly analgesic intake, Numeric Rating Scale (NRS), Headache Impact Test-6 (HIT-6) and Migraine disability assessment (MIDAS) scores, >=50%, >=75%, 100% responders, >=50%, >=75%, 100% responders in patients with medication overuse at weeks 9-12 compared to baseline and adverse events eventually occur during 12 weeks of treatment.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Piero Barbanti; Phone Number: +393357071457; Email: piero.barbanti@sanraffaele.it
• Study Contact Backup: Name: Cinzia Aurilia; Phone Number: +393334147390; Email: cinzia.aurilia@sanraffaele.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

migraine patients with >=4 monthly migraine days (MMDs)

Description

Inclusion Criteria: •

Age: >18 yrs Diagnosis of migraine Migraine frequency: >=4 monthly migraine days (MMDs)

Exclusion Criteria:

Patients using concomitant migraine prophylaxis Use of onabotulinumtoxinA during the previous 12 weeks Exposure to anti-CGRP mAbs during the previous 24 weeks Clinically significant cardiovascular disorders

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in monthly migraine days at weeks 9-12 compared to baseline	variation of number of monthly migraine days	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in monthly analgesic intake at weeks 9-12 compared to baseline	variation of number of analgesic intake	12 weeks
Change in HIT-6 (Headache Impact Test) score at weeks 9-12 compared to baseline	variation of HIT-6	12 weeks
>50%, >75%, 100% responders at weeks 9-12 compared to baseline	proportion of migraine patients who respond to atogepant with reduction of MMDs >=50%, >=75% and 100%	12 weeks
>50%, >75%, 100% responders at weeks 9-12 compared to baseline in patients with Medication overuse	proportion of migraine patients with medication overuse who respond to atogepant with reduction of MMDs >=50%, >=75% and 100%	12 weeks
adverse events	adverse events eventually occur during 12 weeks of treatment	12 weeks
Change in Numerical Rating Scale (NRS) score at weeks 9-12 compared to baseline	variation of Numerical Rating Scale (NRS) score	12 weeks
Change in Migraine Disability Assessment Test Score (MIDAS) at weeks 1-12 compared to baseline Change in MIDAS (Migraine Disability Assessment Score) score at weeks 9-12 compared to baseline	variation of MIDAS	12 weeks

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele Roma

Publications and helpful links

General Publications

• 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. Erratum In: Lancet Neurol. 2020 Nov;19(11):e10.
• Min KC, Kraft WK, Bondiskey P, Colon-Gonzalez F, Liu W, Xu J, Panebianco D, Mixson L, Dockendorf MF, Matthews CZ, Boinpally R. Atogepant Is Not Associated With Clinically Meaningful Alanine Aminotransferase Elevations in Healthy Adults. Clin Transl Sci. 2021 Mar;14(2):599-605. doi: 10.1111/cts.12917. Epub 2020 Nov 24.
• Ailani J, Lipton RB, Goadsby PJ, Guo H, Miceli R, Severt L, Finnegan M, Trugman JM; ADVANCE Study Group. Atogepant for the Preventive Treatment of Migraine. N Engl J Med. 2021 Aug 19;385(8):695-706. doi: 10.1056/NEJMoa2035908.

Study record dates

Study Major Dates

• Study Start (Estimated): April 9, 2024
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IRCCS San Raffaele

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No