NCT07103694·Not applicable·OBSERVATIONAL

i-NEED: NEw migrainE Drugs Database

Calcitonin Other Recruiting

Status

Recruiting

Phase

Not applicable

Enrollment

2,641

Locations

Results

Not posted

Publications

Study summary

What the protocol is testing.

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: * 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.

Full detailed description

The European Headache Federation has published detailed guidelines on the state of the art regarding evidence of effectiveness in reducing the frequency and intensity of headache episodes, as well as the safety and tolerability of the four monoclonal antibodies under "ideal" experimental conditions, with patients selected based on stringent inclusion and exclusion criteria. This selection limits the direct transferability of the conclusions of these studies to clinical reality. Therefore, this study aims to evaluate, in a clinical practice setting, the real effectiveness in reducing the monthly frequency of migraine days and the tolerability and efficacy of monoclonal antibodies in a real-world evidence context. The study may later include all drugs that become available for this condition, subject to authorization by the competent Italian authority. The present extension of the I-NEED study aims to integrate the collection and evaluation of real-life data on anti-CGRP monoclonal antibodies for migraine prophylaxis with the study of efficacy, safety, and tolerability-also in a real-world evidence context-of gepants in the prophylaxis of episodic and chronic migraine, and of rimegepant, ditans, and the sumatriptan-naproxen combination in the acute treatment of migraine.

Interventions

Treatment arms and agents.

DRUG

anti-CGRP monoclonal antibodies

erenumab, fremanezumab, galcanezumab, eptinezumab

DRUG

gepants

atogepant, rimegepant

DRUG

combination of sumatriptan and naproxen

DRUG

ditan

lasmiditan

Timeline

From registration to results.

First posted
Aug 5, 2025
Study start
Mar 24, 2022
Primary completion
Dec 30, 2026
Study completion
Dec 31, 2026
Results posted
Not reported
Registry updated
Jun 11, 2026

Outcomes

What the study measures.

Primary outcomes

effectiveness of innovative drugs as migraine prophylaxis

Time frame · the assessment will be conducted at 4 weeks from treatment initiation

reduction in the number of monthly migraine days compared to the baseline average recorded in the three months preceding treatment

effectiveness of innovative drugs as migraine prophylaxis

Time frame · the assessment will be conducted at 8 weeks from treatment initiation

reduction in the number of monthly migraine days compared to the baseline average recorded in the three months preceding treatment

effectiveness of innovative drug as migraine prophylaxis

Time frame · the assessment will be conducted at 12 weeks from treatment initiation

reduction in the number of monthly migraine days compared to the baseline average recorded in the three months preceding treatment

effectiveness of innovative drugs as migraine prophylaxis

Time frame · the assessment will be conducted at 24 weeks from treatment initiation

reduction in the number of monthly migraine days compared to the baseline average recorded in the three months preceding treatment

effectiveness of innovative drugs as migraine prophylaxis

Time frame · the assessment will be conducted at 48 weeks from treatment initiation

reduction in the number of monthly migraine days compared to the baseline average recorded in the three months preceding treatment

2 hour-pain freedom

Time frame · 2 hours

Percentage of patients reporting complete pain relief within 2 hours after taking the innovative drug for migraine attack

Secondary outcomes

safety and tolerability of innovative drugs as migraine prophylaxis

Time frame · the assessment will be conducted at 48 weeks from treatment initiation

type and number of adverse events occurring during the study period (event details, duration, severity and action taken)

impact of innovative drugs as migraine prophylaxis on symptomatic medication use and medication overuse headache

Time frame · the assessment will be conducted at 48 weeks from treatment initiation

reduction in the average monthly consumption of analgesics in patients undergoing treatment with innovative drugs