Episodic Migrainei-NEEDNCT07103694
i-NEED: NEw migrainE Drugs Database
An observational study of Episodic Migraine and Chronic Migraine, run by IRCCS San Raffaele Roma at 2 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Episodic Migraine, Chronic Migraine, Medication Overuse Headache
- What is being tested?
- anti-CGRP monoclonal antibodies, gepants and combination of sumatriptan and naproxen
- How many people
- 2,641 participants
- Where
- 2 sitesItaly
- Study dates
- 24 Mar 2022to 31 Dec 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients include * adults (equal or more 18 years) * episodic or chronic migraine diagnosis, * treated with preventive or acute treatment drugs
Who may be able to join
- 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 join
- Other headaches different than migraine;
- Known intolerance to the eccipients;
- Vascular disease or Raynaud.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Istituto Auxologico Italiano IRCCS
Milan, Italy, 20145
Alberto Doretti, MD, +39 02 619112937, emitrial@auxologico.it; a.doretti@auxologico.it
- Recruiting
IRCCS San Raffaele
Rome, Italy, 00163
Piero Barbanti, MD, PhD, +390652254318, piero.barbanti@sanraffaele.it
Cinzia Aurilia, MD, +390652254318, cinzia.aurilia@sanraffaele.it
About this study
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.
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.
Read the 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.
- Being tested
- anti-CGRP monoclonal antibodies, gepants, combination of sumatriptan and naproxen, ditan
- Keywords
- migraine, anti-CGRP monoclonal antobodies, gepants, ditans, sumatriptan and naproxen combination
- Medical subject headings
- Headache Disorders, Secondary, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-CGRP monoclonal antibodiesDrug
erenumab, fremanezumab, galcanezumab, eptinezumab
gepantsDrug
atogepant, rimegepant
combination of sumatriptan and naproxenDrug
combination of sumatriptan and naproxen
ditanDrug
lasmiditan
| Study group | Role | What they receive |
|---|---|---|
| individuals affected by migraine | episodic and chronic migraine Receives: Drug: anti-CGRP monoclonal antibodies; Drug: gepants; Drug: combination of sumatriptan and naproxen; Drug: ditan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 2 hours
Secondary outcomes (55)
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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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")
Measured: 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")
Measured: 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")
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 0-48 hours after taking the innovative drug for migraine attack
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start24 Mar 2022
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Episodic MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,641 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103694
- Sponsor's protocol ID
- RP 22/02
- Acronym
- i-NEED
- Status last verified
- Jun 2026
- First submitted
- 29 Apr 2025
- Last updated
- 11 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sacco S, Bendtsen L, Ashina M, Reuter U, Terwindt G, Mitsikostas DD, Martelletti P. European headache federation guideline on the use of monoclonal antibodies acting on the calcitonin gene related peptide or its receptor for migraine prevention. J Headache Pain. 2019 Jan 16;20(1):6. doi: 10.1186/s10194-018-0955-y.
PubMed 30651064Goadsby PJ, Reuter U, Hallstrom Y, Broessner G, Bonner JH, Zhang F, Sapra S, Picard H, Mikol DD, Lenz RA. A Controlled Trial of Erenumab for Episodic Migraine. N Engl J Med. 2017 Nov 30;377(22):2123-2132. doi: 10.1056/NEJMoa1705848.
PubMed 29171821Reuter U, Goadsby PJ, Lanteri-Minet M, Wen S, Hours-Zesiger P, Ferrari MD, Klatt J. Efficacy and tolerability of erenumab in patients with episodic migraine in whom two-to-four previous preventive treatments were unsuccessful: a randomised, double-blind, placebo-controlled, phase 3b study. Lancet. 2018 Nov 24;392(10161):2280-2287. doi: 10.1016/S0140-6736(18)32534-0. Epub 2018 Oct 22.
PubMed 30360965Stauffer VL, Dodick DW, Zhang Q, Carter JN, Ailani J, Conley RR. Evaluation of Galcanezumab for the Prevention of Episodic Migraine: The EVOLVE-1 Randomized Clinical Trial. JAMA Neurol. 2018 Sep 1;75(9):1080-1088. doi: 10.1001/jamaneurol.2018.1212.
PubMed 29813147Detke HC, Goadsby PJ, Wang S, Friedman DI, Selzler KJ, Aurora SK. Galcanezumab in chronic migraine: The randomized, double-blind, placebo-controlled REGAIN study. Neurology. 2018 Dec 11;91(24):e2211-e2221. doi: 10.1212/WNL.0000000000006640. Epub 2018 Nov 16.
PubMed 30446596Dodick DW, Silberstein SD, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T, Grozinski-Wolff M, Yang R, Ma Y, Aycardi E. Effect of Fremanezumab Compared With Placebo for Prevention of Episodic Migraine: A Randomized Clinical Trial. JAMA. 2018 May 15;319(19):1999-2008. doi: 10.1001/jama.2018.4853.
PubMed 29800211Silberstein SD, Dodick DW, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T, Grozinski-Wolff M, Yang R, Ma Y, Aycardi E. Fremanezumab for the Preventive Treatment of Chronic Migraine. N Engl J Med. 2017 Nov 30;377(22):2113-2122. doi: 10.1056/NEJMoa1709038.
PubMed 29171818Dodick DW, Goadsby PJ, Silberstein SD, Lipton RB, Olesen J, Ashina M, Wilks K, Kudrow D, Kroll R, Kohrman B, Bargar R, Hirman J, Smith J; ALD403 study investigators. Safety and efficacy of ALD403, an antibody to calcitonin gene-related peptide, for the prevention of frequent episodic migraine: a randomised, double-blind, placebo-controlled, exploratory phase 2 trial. Lancet Neurol. 2014 Nov;13(11):1100-1107. doi: 10.1016/S1474-4422(14)70209-1. Epub 2014 Oct 5.
PubMed 25297013Lipton RB, Goadsby PJ, Smith J, Schaeffler BA, Biondi DM, Hirman J, Pederson S, Allan B, Cady R. Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE-2. Neurology. 2020 Mar 31;94(13):e1365-e1377. doi: 10.1212/WNL.0000000000009169. Epub 2020 Mar 24.
PubMed 32209650Lipton RB, Croop R, Stock EG, Stock DA, Morris BA, Frost M, Dubowchik GM, Conway CM, Coric V, Goadsby PJ. Rimegepant, an Oral Calcitonin Gene-Related Peptide Receptor Antagonist, for Migraine. N Engl J Med. 2019 Jul 11;381(2):142-149. doi: 10.1056/NEJMoa1811090.
PubMed 31291516Goadsby PJ, Wietecha LA, Dennehy EB, Kuca B, Case MG, Aurora SK, Gaul C. Phase 3 randomized, placebo-controlled, double-blind study of lasmiditan for acute treatment of migraine. Brain. 2019 Jul 1;142(7):1894-1904. doi: 10.1093/brain/awz134.
PubMed 31132795Brandes JL, Kudrow D, Stark SR, O'Carroll CP, Adelman JU, O'Donnell FJ, Alexander WJ, Spruill SE, Barrett PS, Lener SE. Sumatriptan-naproxen for acute treatment of migraine: a randomized trial. JAMA. 2007 Apr 4;297(13):1443-54. doi: 10.1001/jama.297.13.1443.
PubMed 17405970
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07103694
- Acronym / sponsor ID
- i-NEED / RP 22/02
- Keywords
- migraine, anti-CGRP monoclonal antobodies, gepants, ditans, sumatriptan and naproxen combination
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,641 participants (estimated)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| individuals affected by migraine | – | Drug: anti-CGRP monoclonal antibodies, Drug: gepants, Drug: combination of sumatriptan and naproxen, Drug: ditanepisodic and chronic migraine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients include * adults (equal or more 18 years) * episodic or chronic migraine diagnosis, * treated with preventive or acute treatment drugs
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- Other headaches different than migraine;
- Known intolerance to the eccipients;
- Vascular disease or Raynaud.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-CGRP monoclonal antibodieserenumab, fremanezumab, galcanezumab, eptinezumab | Drug | individuals affected by migraine |
| gepantsatogepant, rimegepant | Drug | individuals affected by migraine |
| combination of sumatriptan and naproxencombination of sumatriptan and naproxen | Drug | individuals affected by migraine |
| ditanlasmiditan | Drug | individuals affected by migraine |
Primary outcome
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
55 secondary outcomes
safety and tolerability of innovative drugs as migraine prophylaxis
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
Time frame: the assessment will be conducted at 48 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on migraine symptoms
Time frame: the assessment will be conducted at 4 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on migraine symptoms
Time frame: the assessment will be conducted at 8 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on migraine symptoms
Time frame: the assessment will be conducted at 12 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on migraine symptoms
Time frame: the assessment will be conducted at 24 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on migraine symptoms
Time frame: the assessment will be conducted at 48 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on migraine-related disability
Time frame: the assessment will be conducted at 4 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on migraine-related disability
Time frame: the assessment will be conducted at 8 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on migraine-related disability
Time frame: the assessment will be conducted at 12 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on migraine-related disability
Time frame: the assessment will be conducted at 24 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on migraine-related disability
Time frame: the assessment will be conducted at 48 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on migraine-related disability
Time frame: the assessment will be conducted at 12 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on migraine-related disability
Time frame: the assessment will be conducted at 24 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on migraine-related disability
Time frame: the assessment will be conducted at 48 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on interictal disability
Time frame: the assessment will be conducted at 4 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on interictal disability
Time frame: the assessment will be conducted at 8 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on interictal disability
Time frame: the assessment will be conducted at 12 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on interictal disability
Time frame: the assessment will be conducted at 24 weeks from treatment initiation
impact of innovative drugs as migraine prophylaxis on interictal disability
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
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
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
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
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
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
Time frame: the assessment will be conducted at 48 weeks from treatment initiation
patient subjective perception
Time frame: the assessment will be conducted at 4 weeks from treatment initiation
patient subjective perception
Time frame: the assessment will be conducted at 8 weeks from treatment initiation
patient subjective perception
Time frame: the assessment will be conducted at 12 weeks from treatment initiation
patient subjective perception
Time frame: the assessment will be conducted at 24 weeks from treatment initiation
patient subjective perception
Time frame: the assessment will be conducted at 48 weeks from treatment initiation
response rates to innovative drugs as migraine prophylaxis
Time frame: the assessment will be conducted at 4 weeks from treatment initiation
response rates to innovative drugs as migraine prophylaxis
Time frame: the assessment will be conducted at 8 weeks from treatment initiation
response rates to innovative drugs as migraine prophylaxis
Time frame: the assessment will be conducted at 12 weeks from treatment initiation
response rates to innovative drugs as migraine prophylaxis
Time frame: the assessment will be conducted at 24 weeks from treatment initiation
response rates to innovative drugs as migraine prophylaxis
Time frame: the assessment will be conducted at 48 weeks from treatment initiation
response rates to innovative drugs as migraine prophylaxis
Time frame: the assessment will be conducted at 4 weeks from treatment initiation
response rates to innovative drugs as migraine prophylaxis
Time frame: the assessment will be conducted at 8 weeks from treatment initiation
response rates to innovative drugs as migraine prophylaxis
Time frame: the assessment will be conducted at 12 weeks from treatment initiation
response rates to innovative drugs as migraine prophylaxis
Time frame: the assessment will be conducted at 24 weeks from treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Results publication: PubMed 30651064Sacco S, Bendtsen L, Ashina M, Reuter U, Terwindt G, Mitsikostas DD, Martelletti P. European headache federation guideline on the use of monoclonal antibodies acting on the calcitonin gene related peptide or its receptor for migraine prevention. J Headache Pain. 2019 Jan 16;20(1):6. doi: 10.1186/s10194-018-0955-y.
- Results publication: PubMed 29171821Goadsby PJ, Reuter U, Hallstrom Y, Broessner G, Bonner JH, Zhang F, Sapra S, Picard H, Mikol DD, Lenz RA. A Controlled Trial of Erenumab for Episodic Migraine. N Engl J Med. 2017 Nov 30;377(22):2123-2132. doi: 10.1056/NEJMoa1705848.
- Results publication: PubMed 30360965Reuter U, Goadsby PJ, Lanteri-Minet M, Wen S, Hours-Zesiger P, Ferrari MD, Klatt J. Efficacy and tolerability of erenumab in patients with episodic migraine in whom two-to-four previous preventive treatments were unsuccessful: a randomised, double-blind, placebo-controlled, phase 3b study. Lancet. 2018 Nov 24;392(10161):2280-2287. doi: 10.1016/S0140-6736(18)32534-0. Epub 2018 Oct 22.
- Results publication: PubMed 29813147Stauffer VL, Dodick DW, Zhang Q, Carter JN, Ailani J, Conley RR. Evaluation of Galcanezumab for the Prevention of Episodic Migraine: The EVOLVE-1 Randomized Clinical Trial. JAMA Neurol. 2018 Sep 1;75(9):1080-1088. doi: 10.1001/jamaneurol.2018.1212.
- Results publication: PubMed 30446596Detke HC, Goadsby PJ, Wang S, Friedman DI, Selzler KJ, Aurora SK. Galcanezumab in chronic migraine: The randomized, double-blind, placebo-controlled REGAIN study. Neurology. 2018 Dec 11;91(24):e2211-e2221. doi: 10.1212/WNL.0000000000006640. Epub 2018 Nov 16.
- Results publication: PubMed 29800211Dodick DW, Silberstein SD, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T, Grozinski-Wolff M, Yang R, Ma Y, Aycardi E. Effect of Fremanezumab Compared With Placebo for Prevention of Episodic Migraine: A Randomized Clinical Trial. JAMA. 2018 May 15;319(19):1999-2008. doi: 10.1001/jama.2018.4853.
- Results publication: PubMed 29171818Silberstein SD, Dodick DW, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T, Grozinski-Wolff M, Yang R, Ma Y, Aycardi E. Fremanezumab for the Preventive Treatment of Chronic Migraine. N Engl J Med. 2017 Nov 30;377(22):2113-2122. doi: 10.1056/NEJMoa1709038.
- Results publication: PubMed 25297013Dodick DW, Goadsby PJ, Silberstein SD, Lipton RB, Olesen J, Ashina M, Wilks K, Kudrow D, Kroll R, Kohrman B, Bargar R, Hirman J, Smith J; ALD403 study investigators. Safety and efficacy of ALD403, an antibody to calcitonin gene-related peptide, for the prevention of frequent episodic migraine: a randomised, double-blind, placebo-controlled, exploratory phase 2 trial. Lancet Neurol. 2014 Nov;13(11):1100-1107. doi: 10.1016/S1474-4422(14)70209-1. Epub 2014 Oct 5.
- Results publication: PubMed 32209650Lipton RB, Goadsby PJ, Smith J, Schaeffler BA, Biondi DM, Hirman J, Pederson S, Allan B, Cady R. Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE-2. Neurology. 2020 Mar 31;94(13):e1365-e1377. doi: 10.1212/WNL.0000000000009169. Epub 2020 Mar 24.
- Results publication: PubMed 31291516Lipton RB, Croop R, Stock EG, Stock DA, Morris BA, Frost M, Dubowchik GM, Conway CM, Coric V, Goadsby PJ. Rimegepant, an Oral Calcitonin Gene-Related Peptide Receptor Antagonist, for Migraine. N Engl J Med. 2019 Jul 11;381(2):142-149. doi: 10.1056/NEJMoa1811090.
- Results publication: PubMed 31132795Goadsby PJ, Wietecha LA, Dennehy EB, Kuca B, Case MG, Aurora SK, Gaul C. Phase 3 randomized, placebo-controlled, double-blind study of lasmiditan for acute treatment of migraine. Brain. 2019 Jul 1;142(7):1894-1904. doi: 10.1093/brain/awz134.
- Results publication: PubMed 17405970Brandes JL, Kudrow D, Stark SR, O'Carroll CP, Adelman JU, O'Donnell FJ, Alexander WJ, Spruill SE, Barrett PS, Lener SE. Sumatriptan-naproxen for acute treatment of migraine: a randomized trial. JAMA. 2007 Apr 4;297(13):1443-54. doi: 10.1001/jama.297.13.1443.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Episodic Migraine and Chronic Migraine, run by IRCCS San Raffaele Roma at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Piero Barbanti, MD, PhD (+390652254318, piero.barbanti@sanraffaele.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effectiveness of innovative drugs as migraine prophylaxis (time frame: the assessment will be conducted at 4 weeks from treatment initiation). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07103694, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.