i-NEED: New migraine drugs database
Official title: Italian Real-life Multicenter Observational Study on Efficacy, Tolerability, and Safety of Innovative Drugs (Monoclonal Antibodies, Gepants, Ditans, Sumatriptan-naproxen) for Preventive or Acute Migraine Treatment.
Run by IRCCS San Raffaele Roma · NCT07103694 · Data updated 2026-11-12
This project will collect real-life data to see how new migraine treatments—anti‑CGRP antibodies, gepants, ditans, and a sumatriptan‑naproxen combo—work and how well adults with episodic or chronic migraine tolerate them.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2641 (estimated) |
| Sponsor | IRCCS San Raffaele Roma Academic / other |
| Drugs / interventions | eptinezumab, erenumab, fremanezumab, galcanezumab |
| Locations | 2 sites (Milan, Italy and 1 other locations) |
| Status | Recruiting |
| Started | March 24, 2022 |
| Main results expected | December 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | June 11, 2026 |
| Trial ID | NCT07103694 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with episodic, high‑frequency episodic (≥8 disabling migraine days/month), or chronic migraine who can give informed consent and are managed at the enrolling center are ideal candidates.
✕Probably not a fit
People whose headaches are not migraine, those with specified vascular disease or Raynaud, or those with known intolerance to formulation excipients are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational registry at IRCCS San Raffaele in Rome collects clinical data on adults treated with anti‑CGRP monoclonal antibodies, gepants for prevention, and ditans and a sumatriptan‑naproxen combination for acute attacks. The protocol captures monthly migraine days, responder rates including super‑responders, adverse events, tolerability, and real‑world medication use during routine care. Eligible participants are adults with episodic, high‑frequency episodic, or chronic migraine (ICHD‑III criteria), while patients with non‑migraine headaches or specified vascular conditions are excluded. Collected data will be compared with randomized trial results to better understand effectiveness and safety in everyday clinical practice.
Why it matters
Potential benefit: If successful, the project could give patients and clinicians clearer, real‑world expectations about how effective and tolerable these newer migraine medicines are, helping personalize treatment choices.
How similar studies have gone: Randomized trials and guideline reviews have shown strong efficacy and tolerability for anti‑CGRP antibodies and growing evidence for gepants and ditans, but large real‑world registry data remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age more or equal 18 years; * Males and females; * Willingness to sign the informed consent; * Episodic migraine for the use of drug indicated for migraine attack * High frequency episodic migraine, at least 8 days per month of disabling migraine in the past 3 months; * Chronic migraine, according to the ICHD-III criteria; Exclusion Criteria: * Other headaches different than migraine; * Known intolerance to the eccipients; * Vascular disease or Raynaud.
Where it's running
-
Istituto Auxologico Italiano IRCCS
Milan, Italy, Italy Recruiting -
IRCCS San Raffaele
Rome, Italy, Italy Recruiting
Study contacts
- Study coordinator: Piero Barbanti, MD, PhD
- Email: piero.barbanti@sanraffaele.it
- Phone: +390652254318
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.