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NCT Number: NCT07103694

i-NEED: NEw migrainE Drugs Database

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.

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Key information

Conditions

Episodic Migraine Brain Diseases Central Nervous System Diseases Chronic Migraine Headache Disorders Headache Disorders, Primary Headache Disorders, Secondary Medication Overuse Headache Migraine Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Auxologico Italiano IRCCS, Milan, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

anti-CGRP monoclonal antibodies

Drug

erenumab, fremanezumab, galcanezumab, eptinezumab

gepants

Drug

atogepant, rimegepant

combination of sumatriptan and naproxen

Drug

combination of sumatriptan and naproxen

ditan

Drug

lasmiditan

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  1. 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)

  2. 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

  3. impact of innovative drugs as migraine prophylaxis on migraine symptoms

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

    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

  4. impact of innovative drugs as migraine prophylaxis on migraine symptoms

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

    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

  5. impact of innovative drugs as migraine prophylaxis on migraine symptoms

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

    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

  6. impact of innovative drugs as migraine prophylaxis on migraine symptoms

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

    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

  7. impact of innovative drugs as migraine prophylaxis on migraine symptoms

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

    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

  8. impact of innovative drugs as migraine prophylaxis on migraine-related disability

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

    mean change in Headache Impact Test 6-TM scores (score range 36-78) before treatment

  9. impact of innovative drugs as migraine prophylaxis on migraine-related disability

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

    mean change in Headache Impact Test 6-TM scores (score range 36-78) before treatment

  10. impact of innovative drugs as migraine prophylaxis on migraine-related disability

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

    mean change in Headache Impact Test 6-TM scores (score range 36-78) before treatment

  11. impact of innovative drugs as migraine prophylaxis on migraine-related disability

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

    mean change in Headache Impact Test 6-TM scores (score range 36-78) before treatment

  12. impact of innovative drugs as migraine prophylaxis on migraine-related disability

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

    mean change in Headache Impact Test 6-TM scores (score range 36-78) before treatment

  13. impact of innovative drugs as migraine prophylaxis on migraine-related disability

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

    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

  14. impact of innovative drugs as migraine prophylaxis on migraine-related disability

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

    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

  15. impact of innovative drugs as migraine prophylaxis on migraine-related disability

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

    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

  16. impact of innovative drugs as migraine prophylaxis on interictal disability

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

    Mean change in Migraine Interictal Burden Scale-4 (score range: 0-12)

  17. impact of innovative drugs as migraine prophylaxis on interictal disability

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

    Mean change in Migraine Interictal Burden Scale-4 (score range: 0-12)

  18. impact of innovative drugs as migraine prophylaxis on interictal disability

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

    Mean change in Migraine Interictal Burden Scale-4 (score range: 0-12)

  19. impact of innovative drugs as migraine prophylaxis on interictal disability

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

    Mean change in Migraine Interictal Burden Scale-4 (score range: 0-12)

  20. impact of innovative drugs as migraine prophylaxis on interictal disability

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

    mean change in Migraine Interictal Burden Scale-4 score (score range: 0-12)

  21. impact of innovative drugs as migraine prophylaxis on work-related difficulties due to migraine

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

    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")

  22. impact of innovative drugs as migraine prophylaxis on work-related difficulties due to migraine

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

    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")

  23. impact of innovatine drugs as migraine prophylaxis on work-related difficulties due to migraine

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

    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")

  24. impact of innovative drugs as migraine prophylaxis on economic resources in migraine

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

    mean change in the COSTI questionnaire score (evaluation of both direct and indirect cost directly gathered from patients)

  25. impact of innovative drugs as migraine prophylaxis on economic resources in migraine

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

    mean change in the COSTI questionnaire score (evaluation of both direct and indirect cost directly gathered from patients)

  26. impact of innovative drugs as migraine prophylaxis on economic resources in migraine

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

    mean change in the COSTI questionnaire score (evaluation of both direct and indirect cost directly gathered from patients)

  27. patient subjective perception

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

    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)

  28. patient subjective perception

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

    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)

  29. patient subjective perception

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

    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)

  30. patient subjective perception

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

    assessment of subjective perception of change through Patient Global Impression of Change (score range 1-7)

  31. patient subjective perception

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

    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)

  32. response rates to innovative drugs as migraine prophylaxis

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

    percentage of patients achieving a >50% reduction in monthly migraine days compared to the pre-treatment period

  33. response rates to innovative drugs as migraine prophylaxis

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

    percentage of patients achieving a >50% reduction in monthly migraine days compared to the pre-treatment period

  34. response rates to innovative drugs as migraine prophylaxis

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

    percentage of patients achieving a >50% reduction in monthly migraine days compared to the pre-treatment period

  35. response rates to innovative drugs as migraine prophylaxis

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

    percentage of patients achieving a >50% reduction in monthly migraine days compared to the pre-treatment period

  36. response rates to innovative drugs as migraine prophylaxis

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

    percentage of patients achieving a >50% reduction in monthly migraine days compared to the pre-treatment period

  37. response rates to innovative drugs as migraine prophylaxis

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

    percentage of patients achieving a >75% reduction in monthly migraine days compared to the pre-treatment period

  38. response rates to innovative drugs as migraine prophylaxis

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

    percentage of patients achieving a >75% reduction in monthly migraine days compared to the pre-treatment period

  39. response rates to innovative drugs as migraine prophylaxis

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

    percentage of patients achieving a >75% reduction in monthly migraine days compared to the pre-treatment period

  40. response rates to innovative drugs as migraine prophylaxis

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

    percentage of patients achieving a >75% reduction in monthly migraine days compared to the pre-treatment period

  41. response rates to innovative drugs as migraine prophylaxis

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

    percentage of patients achieving a >75% reduction in monthly migraine days compared to the pre-treatment period

  42. response rates to innovative drugs as migraine prophylaxis

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

    percentage of patients achieving a 100% reduction in monthly migraine days compared to the pre-treatment period

  43. response rates to innovative drugs as migraine prophylaxis

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

    percentage of patients achieving a 100% reduction in monthly migraine days compared to the pre-treatment period

  44. response rates to innovative drugs as migraine prophylaxis

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

    percentage of patients achieving a 100% reduction in monthly migraine days compared to the pre-treatment period

  45. response rates to innovative drugs as migraine prophylaxis

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

    percentage of patients achieving a 100% reduction in monthly migraine days compared to the pre-treatment period

  46. response rates to innovative drugs as migraine prophylaxis

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

    percentage of patients achieving a 100% reduction in monthly migraine days compared to the pre-treatment period

  47. 1 hour-pain freedom

    Time frame: 1 hour after taking the innovative drug for migraine attack

    Percentage of patients reporting complete pain relief within 1 hour after taking the innovative drug for migraine attack

  48. 2 hours-pain relief

    Time frame: 2 hours after taking the innovative drug for migraine attack

    percentage of patients reporting a 50% reduction in pain intensity wiithin 2 hours after taking the innovative drug for migraine attack

  49. disappearance of Most Bothersone Symptom

    Time frame: 2 hours after taking the innovative drug for migraine attack

    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

  50. presence or absence of associated symptoms (nausea, vomiting, photophobia, phonophobia)

    Time frame: 1-48 hours after taking the innovative drug for migraine attack

    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

  51. 24 hour-sustained pain freedom

    Time frame: 24 hours after taking the innovative drug for migraine attack

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

  52. 24 hour-sustained pain relief

    Time frame: 24 hours after taking the innovative drug for migraine attack

    percentage of patients experiencing a 50% reduction in pain intensity within 2 hours after taking the innovative drug for migraine attack

  53. headache recurrence

    Time frame: 2 hours after taking the innovative drug for migraine attack

    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)

  54. use of rescue medication

    Time frame: 24 hours after taking the innovative drug for migraine attack

    use of rescue medication and evaluation of the time interval between the first and the second dose

  55. adverse occurence

    Time frame: 0-48 hours after taking the innovative drug for migraine attack

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Cinzia Aurilia

CONTACT

[email protected]

+390652254318

Piero Barbanti, MD, PhD

CONTACT

[email protected]

+390652254318

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele Roma

Other

Registry information

Official study 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.

Acronym: i-NEED

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 5, 2025
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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