RecruitingNot Applicable

EptinezuMaB in ReAl-world evidenCE: Multicenter, Real Life, Cohort Study in Migraine.

Italy500 participantsStarted 2023-01-01

Plain-language summary

The object of this study is to assess the effectiveness, safety, and tolerability of eptinezumab in a real life migraine population.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age between 18 and 75 years;
. Males and females;
. Willingness to sign the informed consent;
. 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 eptinezumab or eccipients;
. Current treatment with other mAbs;
. Vascular disease or Raynaud.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline in monthly migraine days (MMD) in HFEM or monthly headache days (MHD) in CM;

Timeframe: over 12 weeks of treatment compared to baseline

Change from baseline in MMD in HFEM or MHD in CM;

Timeframe: over 24 weeks of treatment compared to baseline

Change from baseline in MMD in HFEM or MHD in CM;

Timeframe: over 48 weeks of treatment compared to baseline

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Timeframe: over 12 months of treatment compared to baseline

Trial details

NCT IDNCT05570149

SponsorIRCCS San Raffaele Roma

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-31

Contact for this trial

Piero Barbanti, MD, PhD

+393357071457 piero.barbanti@sanraffaele.it

View on ClinicalTrials.gov More Migraine Disorders trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age between 18 and 75 years;
. Males and females;
. Willingness to sign the informed consent;
. 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 eptinezumab or eccipients;
. Current treatment with other mAbs;
. Vascular disease or Raynaud.

What they're measuring

Change from baseline in monthly migraine days (MMD) in HFEM or monthly headache days (MHD) in CM;

Timeframe: over 12 weeks of treatment compared to baseline

Change from baseline in MMD in HFEM or MHD in CM;

Timeframe: over 24 weeks of treatment compared to baseline

Change from baseline in MMD in HFEM or MHD in CM;

Timeframe: over 48 weeks of treatment compared to baseline

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Timeframe: over 12 months of treatment compared to baseline