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Taking people in ItalyNo phase

Observes real-world use of newer migraine drugs in Italy

Studies how newer migraine medicines work and feel in adults with migraine.

Key facts

Who runs it
IRCCS San Raffaele Roma
Where
Milan and Rome, ItalySee the 2 sites
Trial code
Registry title
i-NEED: NEw migrainE Drugs Database
Status
Recruiting
People taking part
2,641 people, planned
Started
24 Mar 2022
Expected to end
31 Dec 2026
Type of study
Observational
Treatments tested
  • anti-CGRP monoclonal antibodies
  • gepants
  • combination of sumatriptan and naproxen
  • ditan
Record updated
11 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with episodic or chronic migraine who use or are about to use newer migraine drugs for prevention or for treating attacks.

Age
18 years or older.
Sex
Men and women can join.
Disease stage
Episodic migraine (for drugs that treat an attack), high-frequency episodic migraine with at least 8 days per month of disabling migraine in the past 3 months, or chronic migraine by ICHD-III criteria.

Main reasons for not taking part

  • Headaches other than migraine
  • Known intolerance to the excipients
  • Vascular disease or Raynaud

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Vascular disease or Raynaud
  • Other headaches different than migraine
  • Known intolerance to the eccipients

Where in Italy

  • Istituto Auxologico Italiano IRCCSMilan, ItalyContact: Alberto Doretti, MDTaking people
  • IRCCS San RaffaeleRome, ItalyContact: Piero Barbanti, MD, PhDTaking people

About the trial

What the trial wants to find out

Approved by the Food and Drug Administration (FDA) and the European Medicine Agency (EMA) starting in 2018, anti-CGRP monoclonal antibodies (anti-CGRP mAbs) represent the first true revolution in the preventive treatment of migraine due to their selectivity and specificity. To date, four anti-CGRP mAbs have been developed for the preventive treatment of migraine: eptinezumab, erenumab, fremanezumab, and galcanezumab.Anti-CGRP mAbs constitute not only the first specific and selective treatment for the prevention of migraine but also the most extensively studied pharmacological category in this field, considering the vast and complex populations examined. The clinical effects of the various mAbs are substantially comparable and are characterized by several fundamental aspects:

Read full original descriptionShow less

* High efficacy in both episodic and chronic migraine, with the presence of super-responders who experience a reduction in the average monthly number of migraine days of >75% (or even 100%) compared to before treatment. * Efficacy that is independent of the clinical form of migraine - with or without aura - and regardless of whether there is analgesic overuse. * Efficacy maintained even in the presence of depressive or anxious comorbidities. * Rapid onset of action (even more pronounced with eptinezumab), with the therapeutic effect appearing within the first week in most cases. * Excellent tolerability with an absence of class-specific adverse events. * Outstanding treatment adherence and a very low rate of treatment discontinuation in the long term. It should also be noted that the development of anti-drug antibodies or neutralizing antibodies to anti-CGRP mAbs is rare and does not significantly impact the efficacy or tolerability of treatment. Future clinical practice will need to clarify several additional aspects, such as: 1) whether treatment with anti-CGRP mAbs can modify the course of migraine; 2) the appropriate approach regarding any traditional preventive treatment (whether to continue or discontinue it); 3) the definition of the characteristics of non-responders; 4) the definition of patients with a delayed response to treatment.

Gepants are oral antagonists of the CGRP receptor. Among the four gepants synthesized so far (atogepant, rimegepant, ubrogepant, zavegepant), atogepant and rimegepant are currently available in Italy. Atogepant has proven to be an effective and well-tolerated option for the prevention of episodic and chronic migraines. Rimegepant is effective for both acute treatment and prevention of migraines, with a favorable safety profile and flexible oral administration. Lasmiditan is the first ditan effective for migraine attack and it represents a new therapeutic option for patients with contraindications to triptans, due to the presence of vascular risk factors, or for patients who experience undesirable side effects with these, thus increasing the therapeutic possibilities for the symptomatic treatment of migraine. The combination of sumatriptan 85 mg and naproxen sodium 500 mg is indicated for the acute treatment of migraine attacks in adult patients for whom sumatriptan monotherapy is insufficient.

The group in the trial

  • individuals affected by migraine

    episodic and chronic migraine

    Treatment: anti-CGRP monoclonal antibodies, gepants, combination of sumatriptan and naproxen, and ditan

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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.
Plain-language title
Observes real-world use of newer migraine drugs in ItalyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
11 June 2026