Clinical trial NCT06136442: Atogepant in Real Life in Italy (GIANT)
Official title: Atogepant in Real Life in Italy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Migraine, Prophylaxis
Lead sponsor: IRCCS San Raffaele Roma
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: migraine patients with \>=4 monthly migraine days (MMDs)

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in monthly migraine days at weeks 9-12 compared to baseline
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in monthly analgesic intake at weeks 9-12 compared to baseline
timeFrame: 12 weeks
measure: Change in Numerical Rating Scale (NRS) score at weeks 9-12 compared to baseline
timeFrame: 12 weeks
measure: Change in HIT-6 (Headache Impact Test) score at weeks 9-12 compared to baseline
timeFrame: 12 weeks
measure: 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
timeFrame: 12 weeks
measure: >50%, >75%, 100% responders at weeks 9-12 compared to baseline
timeFrame: 12 weeks
measure: >50%, >75%, 100% responders at weeks 9-12 compared to baseline in patients with Medication overuse
timeFrame: 12 weeks
measure: adverse events
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
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: 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.
citation: 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.