An observational study in Episodic Migraine, Chronic Migraine and Medication Overuse Headache, sponsored by IRCCS San Raffaele Roma. Recruiting at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by IRCCS San Raffaele Roma · Observational
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:
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 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.
52 studies on the registry are indexed under Headache Disorders, Secondary; 13 are open to participants now.
This study's planned enrollment of 2,641 is above the median of 122 across 17 observational studies indexed under Headache Disorders, Secondary.
Browse Headache Disorders, Secondary studies →IRCCS San Raffaele Roma is the lead sponsor of 71 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Eligible patients include
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
episodic and chronic migraine
Drug: anti-CGRP monoclonal antibodies · Drug: gepants · Drug: combination of sumatriptan and naproxen · Drug: ditan
erenumab, fremanezumab, galcanezumab, eptinezumab
atogepant, rimegepant
Drug pages: Sumatriptan · Naproxen
combination of sumatriptan and naproxen
lasmiditan
effectiveness of innovative drugs as migraine prophylaxis
reduction in the number of monthly migraine days compared to the baseline average recorded in the three months preceding treatment
Time frame: the assessment will be conducted at 4 weeks from treatment initiation
effectiveness of innovative drugs as migraine prophylaxis
reduction in the number of monthly migraine days compared to the baseline average recorded in the three months preceding treatment
Time frame: the assessment will be conducted at 8 weeks from treatment initiation
effectiveness of innovative drug as migraine prophylaxis
reduction in the number of monthly migraine days compared to the baseline average recorded in the three months preceding treatment
Time frame: the assessment will be conducted at 12 weeks from treatment initiation
effectiveness of innovative drugs as migraine prophylaxis
reduction in the number of monthly migraine days compared to the baseline average recorded in the three months preceding treatment
Time frame: the assessment will be conducted at 24 weeks from treatment initiation
effectiveness of innovative drugs as migraine prophylaxis
reduction in the number of monthly migraine days compared to the baseline average recorded in the three months preceding treatment
Time frame: the assessment will be conducted at 48 weeks from treatment initiation
2 hour-pain freedom
Percentage of patients reporting complete pain relief within 2 hours after taking the innovative drug for migraine attack
Time frame: 2 hours
safety and tolerability of innovative drugs as migraine prophylaxis
type and number of adverse events occurring during the study period (event details, duration, severity and action taken)
Time frame: the assessment will be conducted at 48 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on symptomatic medication use and medication overuse headache
reduction in the average monthly consumption of analgesics in patients undergoing treatment with innovative drugs
Time frame: the assessment will be conducted at 48 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on migraine symptoms
mean change in perceived pain intensity during a migraine attack (measured using the Numerical Rating Scale, score range 0-10) compared to the pre-treatment period
Time frame: the assessment will be conducted at 4 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on migraine symptoms
mean change in perceived pain intensity during a migraine attack (measured using the Numerical Rating Scale, score range 0-10) compared to the pre-treatment period
Time frame: the assessment will be conducted at 8 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on migraine symptoms
mean change in perceived pain intensity during a migraine attack (measured using the Numerical Rating Scale, score range 0-10) compared to the pre-treatment period
Time frame: the assessment will be conducted at 12 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on migraine symptoms
mean change in perceived pain intensity during a migraine attack (measured using the Numerical Rating Scale, score range 0-10) compared to the pre-treatment period
Time frame: the assessment will be conducted at 24 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on migraine symptoms
mean change in perceived pain intensity during a migraine attack (measured using the Numerical Rating Scale, score range 0-10) compared to the pre-treatment period
Time frame: the assessment will be conducted at 48 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on migraine-related disability
mean change in Headache Impact Test 6-TM scores (score range 36-78) before treatment
Time frame: the assessment will be conducted at 4 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on migraine-related disability
mean change in Headache Impact Test 6-TM scores (score range 36-78) before treatment
Time frame: the assessment will be conducted at 8 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on migraine-related disability
mean change in Headache Impact Test 6-TM scores (score range 36-78) before treatment
Time frame: the assessment will be conducted at 12 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on migraine-related disability
mean change in Headache Impact Test 6-TM scores (score range 36-78) before treatment
Time frame: the assessment will be conducted at 24 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on migraine-related disability
mean change in Headache Impact Test 6-TM scores (score range 36-78) before treatment
Time frame: the assessment will be conducted at 48 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on migraine-related disability
mean change in Migraine Disability Assessment Score Questionnaire (grade I: 0-5; grade II: 6-10; grade III: 11-20; grade IV\>21) before treatment
Time frame: the assessment will be conducted at 12 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on migraine-related disability
mean change in Migraine Disability Assessment Score Questionnaire (grade I: 0-5; grade II: 6-10; grade III: 11-20; grade IV\>21) before treatment
Time frame: the assessment will be conducted at 24 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on migraine-related disability
mean change in Migraine Disability Assessment Score Questionnaire (grade I: 0-5; grade II: 6-10; grade III: 11-20; grade IV\>21) before treatment
Time frame: the assessment will be conducted at 48 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on interictal disability
Mean change in Migraine Interictal Burden Scale-4 (score range: 0-12)
Time frame: the assessment will be conducted at 4 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on interictal disability
Mean change in Migraine Interictal Burden Scale-4 (score range: 0-12)
Time frame: the assessment will be conducted at 8 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on interictal disability
Mean change in Migraine Interictal Burden Scale-4 (score range: 0-12)
Time frame: the assessment will be conducted at 12 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on interictal disability
Mean change in Migraine Interictal Burden Scale-4 (score range: 0-12)
Time frame: the assessment will be conducted at 24 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on interictal disability
mean change in Migraine Interictal Burden Scale-4 score (score range: 0-12)
Time frame: the assessment will be conducted at 48 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on work-related difficulties due to migraine
mean change in the HEADWORK questionnaire score (two sections: the first one includes 13 items and the second one 12 items: every item requires a five point response scale ranging between 1-"no difficulty"-, 5 - "I cannot do it")
Time frame: the assessment will be conducted at 12 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on work-related difficulties due to migraine
mean change in the HEADWORK questionnaire score (two sections: the first one includes 13 items and the second one 12 items: every item requires a five point response scale ranging between 1-"no difficulty"-, 5 - "I cannot do it")
Time frame: the assessment will be conducted at 24 weeks from treatment initiation
impact of innovatine drugs as migraine prophylaxis on work-related difficulties due to migraine
mean change in the HEADWORK questionnaire score (two sections: the first one includes 13 items and the second one 12 items: every item requires a five point response scale ranging between 1-"no difficulty"-, 5 - "I cannot do it")
Time frame: the assessment will be conducted at 48 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on economic resources in migraine
mean change in the COSTI questionnaire score (evaluation of both direct and indirect cost directly gathered from patients)
Time frame: the assessment will be conducted at 12 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on economic resources in migraine
mean change in the COSTI questionnaire score (evaluation of both direct and indirect cost directly gathered from patients)
Time frame: the assessment will be conducted at 24 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on economic resources in migraine
mean change in the COSTI questionnaire score (evaluation of both direct and indirect cost directly gathered from patients)
Time frame: the assessment will be conducted at 48 weeks from treatment initiation
patient subjective perception
collection of subjective feedback from the patients regarding their experience with the medication, assessing patient satisfaction, ease of use of the medication perceived effectiveness with Patient Global Impression of Change (score range 1-7)
Time frame: the assessment will be conducted at 4 weeks from treatment initiation
patient subjective perception
collection of subjective feedback from the patients regarding their experience with the medication, assessing patient satisfaction, ease of use of the medication perceived effectiveness with Patient Global Impression of Change (score range 1-7)
Time frame: the assessment will be conducted at 8 weeks from treatment initiation
patient subjective perception
collection of subjective feedback from the patients regarding their experience with the medication, assessing patient satisfaction, ease of use of the medication perceived effectiveness with Patient Global Impression of Change (score range 1-7)
Time frame: the assessment will be conducted at 12 weeks from treatment initiation
patient subjective perception
assessment of subjective perception of change through Patient Global Impression of Change (score range 1-7)
Time frame: the assessment will be conducted at 24 weeks from treatment initiation
patient subjective perception
collection of subjective feedback from the patients regarding their experience with the medication, assessing patient satisfaction, ease of use of the medication perceived effectiveness with Patient Global Impression of Change (score range 1-7)
Time frame: the assessment will be conducted at 48 weeks from treatment initiation
response rates to innovative drugs as migraine prophylaxis
percentage of patients achieving a \>50% reduction in monthly migraine days compared to the pre-treatment period
Time frame: the assessment will be conducted at 4 weeks from treatment initiation
response rates to innovative drugs as migraine prophylaxis
percentage of patients achieving a \>50% reduction in monthly migraine days compared to the pre-treatment period
Time frame: the assessment will be conducted at 8 weeks from treatment initiation
response rates to innovative drugs as migraine prophylaxis
percentage of patients achieving a \>50% reduction in monthly migraine days compared to the pre-treatment period
Time frame: the assessment will be conducted at 12 weeks from treatment initiation
response rates to innovative drugs as migraine prophylaxis
percentage of patients achieving a \>50% reduction in monthly migraine days compared to the pre-treatment period
Time frame: the assessment will be conducted at 24 weeks from treatment initiation
response rates to innovative drugs as migraine prophylaxis
percentage of patients achieving a \>50% reduction in monthly migraine days compared to the pre-treatment period
Time frame: the assessment will be conducted at 48 weeks from treatment initiation
response rates to innovative drugs as migraine prophylaxis
percentage of patients achieving a \>75% reduction in monthly migraine days compared to the pre-treatment period
Time frame: the assessment will be conducted at 4 weeks from treatment initiation
response rates to innovative drugs as migraine prophylaxis
percentage of patients achieving a \>75% reduction in monthly migraine days compared to the pre-treatment period
Time frame: the assessment will be conducted at 8 weeks from treatment initiation
response rates to innovative drugs as migraine prophylaxis
percentage of patients achieving a \>75% reduction in monthly migraine days compared to the pre-treatment period
Time frame: the assessment will be conducted at 12 weeks from treatment initiation
response rates to innovative drugs as migraine prophylaxis
percentage of patients achieving a \>75% reduction in monthly migraine days compared to the pre-treatment period
Time frame: the assessment will be conducted at 24 weeks from treatment initiation
response rates to innovative drugs as migraine prophylaxis
percentage of patients achieving a \>75% reduction in monthly migraine days compared to the pre-treatment period
Time frame: the assessment will be conducted at 48 weeks from treatment initiation
response rates to innovative drugs as migraine prophylaxis
percentage of patients achieving a 100% reduction in monthly migraine days compared to the pre-treatment period
Time frame: the assessment will be conducted at 4 weeks from treatment initiation
response rates to innovative drugs as migraine prophylaxis
percentage of patients achieving a 100% reduction in monthly migraine days compared to the pre-treatment period
Time frame: the assessment will be conducted at 8 weeks from treatment initiation
response rates to innovative drugs as migraine prophylaxis
percentage of patients achieving a 100% reduction in monthly migraine days compared to the pre-treatment period
Time frame: the assessment will be conducted at 12 weeks from treatment initiation
response rates to innovative drugs as migraine prophylaxis
percentage of patients achieving a 100% reduction in monthly migraine days compared to the pre-treatment period
Time frame: the assessment will be conducted at 24 weeks from treatment initiation
response rates to innovative drugs as migraine prophylaxis
percentage of patients achieving a 100% reduction in monthly migraine days compared to the pre-treatment period
Time frame: the assessment will be conducted at 48 weeks from treatment initiation
1 hour-pain freedom
Percentage of patients reporting complete pain relief within 1 hour after taking the innovative drug for migraine attack
Time frame: 1 hour after taking the innovative drug for migraine attack
2 hours-pain relief
percentage of patients reporting a 50% reduction in pain intensity wiithin 2 hours after taking the innovative drug for migraine attack
Time frame: 2 hours after taking the innovative drug for migraine attack
disappearance of Most Bothersone Symptom
percentage of patients experiencing the disappearence of the Most Bothersone Symptom (the most disabling by the patient) within wiithin 2 hours after taking the innovative drug for migraine attack
Time frame: 2 hours after taking the innovative drug for migraine attack
presence or absence of associated symptoms (nausea, vomiting, photophobia, phonophobia)
presence or absence of associated symptoms (nausea, vomiting, photophobia, phonophobia) at predefined time intervals of 1, 2, 3, 4, 6, 8, 24 and 48 hours
Time frame: 1-48 hours after taking the innovative drug for migraine attack
24 hour-sustained pain freedom
percentage of patients experiencing complete pain relief within 2 hours after taking the innovative drug for migraine attack
Time frame: 24 hours after taking the innovative drug for migraine attack
24 hour-sustained pain relief
percentage of patients experiencing a 50% reduction in pain intensity within 2 hours after taking the innovative drug for migraine attack
Time frame: 24 hours after taking the innovative drug for migraine attack
headache recurrence
definition of the moment of possible migraine pain recurrence (headache recurernce), as well as its intensity within 24 and 48 hours following the administration of the medication (limited to patients who experienced pain freedom within 2 hours)
Time frame: 2 hours after taking the innovative drug for migraine attack
use of rescue medication
use of rescue medication and evaluation of the time interval between the first and the second dose
Time frame: 24 hours after taking the innovative drug for migraine attack
adverse occurence
definition of the type and number of adverse events occurring within 48 hours of taking the innovative drug for migraine attack (event details, duration, severity and action taken)
Time frame: 0-48 hours after taking the innovative drug for migraine attack
Started Mar 2022 (actual). Primary completion is estimated for Dec 2026, 57 months after the start.
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IRCCS San Raffaele Roma