Migraine, ProphylaxisGIANTNCT06136442
Atogepant in Real Life in Italy (GIANT)
An observational study of Migraine, Prophylaxis, run by IRCCS San Raffaele Roma.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Migraine, Prophylaxis
- What is being tested?
- Atogepant
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 9 Apr 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: migraine patients with >=4 monthly migraine days (MMDs)
Who may be able to join
- Age: >18 yrs Diagnosis of migraine Migraine frequency: >=4 monthly migraine days (MMDs)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Migraine, Prophylaxis
- Being tested
- Atogepant
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtogepantDrug
atogepant in real life in Italy
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in monthly migraine days at weeks 9-12 compared to baseline
variation of number of monthly migraine days
Measured: 12 weeks
Secondary outcomes (7)
Change in monthly analgesic intake at weeks 9-12 compared to baseline
variation of number of analgesic intake
Measured: 12 weeks
Change in Numerical Rating Scale (NRS) score at weeks 9-12 compared to baseline
variation of Numerical Rating Scale (NRS) score
Measured: 12 weeks
Change in HIT-6 (Headache Impact Test) score at weeks 9-12 compared to baseline
variation of HIT-6
Measured: 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
Measured: 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%
Measured: 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%
Measured: 12 weeks
adverse events
adverse events eventually occur during 12 weeks of treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start9 Apr 2024 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Migraine, ProphylaxisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136442
- Sponsor's protocol ID
- IRCCS San Raffaele
- Acronym
- GIANT
- Status last verified
- Jan 2024
- First submitted
- 13 Nov 2023
- Last updated
- 10 Apr 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32822633Min 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.
PubMed 33142014Ailani 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.
PubMed 34407343Barbanti P, Egeo G, Doretti A, Pistoia F, Rinalduzzi S, Strumia S, Aurilia C, Scatena P, Autunno M, Salerno A, Galli A, Altavilla R, Messina S, Zanferrari C, Bruno P, Camarda C, D'Onofrio F, Iovene V, Ranieri A, Bono F, de Souza JS, Carnevale A, Di Clemente L, Zucco M, Bandettini Di Poggio ML, Vinciguerra L, Borrello L, Fiorentini G, Vecchio R, Drago V, Torelli P, Albanese M, Tomino C, Bonassi S, Porreca A; Italian Migraine Registry (I-GRAINE) study group. Responders and super-responders to atogepant after 24 weeks of treatment in migraine: real-world evidence from the GIANT-2 study. J Headache Pain. 2026 Jan 31;27(1):68. doi: 10.1186/s10194-026-02277-3.
PubMed 41620660
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atogepant in Real Life in Italy
- ClinicalTrials.gov ID
- NCT06136442
- Acronym / sponsor ID
- GIANT / IRCCS San Raffaele
- Conditions
- Migraine, Prophylaxis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Study start
- 9 Apr 2024 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- migraine patients with >=4 monthly migraine days (MMDs)
Key inclusion criteria (1 listed)
- Age: >18 yrs Diagnosis of migraine Migraine frequency: >=4 monthly migraine days (MMDs)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atogepantatogepant in real life in Italy | Drug | – |
Primary outcome
Change in monthly migraine days at weeks 9-12 compared to baseline
Time frame: 12 weeks
variation of number of monthly migraine days
7 secondary outcomes
Change in monthly analgesic intake at weeks 9-12 compared to baseline
Time frame: 12 weeks
Change in Numerical Rating Scale (NRS) score at weeks 9-12 compared to baseline
Time frame: 12 weeks
Change in HIT-6 (Headache Impact Test) score at weeks 9-12 compared to baseline
Time frame: 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
Time frame: 12 weeks
>50%, >75%, 100% responders at weeks 9-12 compared to baseline
Time frame: 12 weeks
>50%, >75%, 100% responders at weeks 9-12 compared to baseline in patients with Medication overuse
Time frame: 12 weeks
adverse events
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Results publication: PubMed 32822633Goadsby 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.
- Results publication: PubMed 33142014Min 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.
- Results publication: PubMed 34407343Ailani 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.
- Derived from this study: PubMed 41620660Barbanti P, Egeo G, Doretti A, Pistoia F, Rinalduzzi S, Strumia S, Aurilia C, Scatena P, Autunno M, Salerno A, Galli A, Altavilla R, Messina S, Zanferrari C, Bruno P, Camarda C, D'Onofrio F, Iovene V, Ranieri A, Bono F, de Souza JS, Carnevale A, Di Clemente L, Zucco M, Bandettini Di Poggio ML, Vinciguerra L, Borrello L, Fiorentini G, Vecchio R, Drago V, Torelli P, Albanese M, Tomino C, Bonassi S, Porreca A; Italian Migraine Registry (I-GRAINE) study group. Responders and super-responders to atogepant after 24 weeks of treatment in migraine: real-world evidence from the GIANT-2 study. J Headache Pain. 2026 Jan 31;27(1):68. doi: 10.1186/s10194-026-02277-3.
- Individual participant dataSharing planned: No
Related trials for Migraine, Prophylaxis
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Not yet recruitingPhase 4
Migraine Menopause Study
Migraine, Menopausal
RecruitingPhase 2
Study of EVO756 in Adults With Migraine
Migraine
Active, not recruiting
MMA Embolization for Refractory Chronic Migraine
Migraine Disorders
Active, not recruiting
Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Preventative Treatment for Migraine
Migraine
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, Prophylaxis, run by IRCCS San Raffaele Roma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Piero Barbanti (+393357071457, piero.barbanti@sanraffaele.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in monthly migraine days at weeks 9-12 compared to baseline (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06136442, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.