Atogepant in Real Life in Italy (GIANT)

NCT06136442 | Unknown FDA Drug

• 1 other identifier: IRCCS San Raffaele
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Migraine, Prophylaxis

Outcome Measures

Primary Outcomes (1)

• Change in monthly migraine days at weeks 9-12 compared to baseline

  variation of number of monthly migraine days

  12 weeks

Secondary Outcomes (7)

• Change in monthly analgesic intake at weeks 9-12 compared to baseline

  12 weeks

• Change in Numerical Rating Scale (NRS) score at weeks 9-12 compared to baseline

  12 weeks

• Change in HIT-6 (Headache Impact Test) score at weeks 9-12 compared to baseline

  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

  12 weeks

• >50%, >75%, 100% responders at weeks 9-12 compared to baseline

  12 weeks

Interventions

Atogepant DRUG

atogepant in real life in Italy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead

Related Publications (3)

• 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 RESULT

• 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.

  PMID: 33142014 RESULT

• 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.

  PMID: 34407343 RESULT

MeSH Terms

Conditions

Migraine Disorders

Interventions

atogepant

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Piero Barbanti

CONTACT

+393357071457; piero.barbanti@sanraffaele.it

Cinzia Aurilia

CONTACT

+393334147390; cinzia.aurilia@sanraffaele.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: April 9, 2024
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: April 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share