Clinical Trials in Italy / NCT05570149
Recruiting
Observational
EptinezuMaB in ReAl-world evidenCE: Multicenter, Real Life, Cohort Study in Migraine.
NCT05570149 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Migraine Disorders
Investigational drug(s) / intervention(s)
Eptinezumab 100 mg or Eptinezumab 300 mg administered intravenously in 100 mL saline solution: migraine prophylaxis
Study summary
The object of this study is to assess the effectiveness, safety, and tolerability of eptinezumab in a real life migraine population.
Eligibility
KEY INCLUSION CRITERIA
1. Age between 18 and 75 years;
2. Males and females;
3. Willingness to sign the informed consent;
4. High frequency episodic migraine, at least 8 days per month of disabling migraine in the past 3 months;
5. Chronic migraine, according to the ICHD-III criteria;
KEY EXCLUSION CRITERIA
1. Other headaches different than migraine;
2. Known intolerance to eptinezumab or eccipients;
3. Current treatment with other mAbs;
4. Vascular disease or Raynaud.
Primary outcome measure(s)
- Change from baseline in monthly migraine days (MMD) in HFEM or monthly headache days (MHD) in CM; — over 12 weeks of treatment compared to baseline
assessment of MMD or MHD - Change from baseline in MMD in HFEM or MHD in CM; — over 24 weeks of treatment compared to baseline
assessment of MMD or MHD - Change from baseline in MMD in HFEM or MHD in CM; — over 48 weeks of treatment compared to baseline
assessment of MMD or MHD - Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] — over 12 months of treatment compared to baseline
assessment of occurrence of Treatment-Emergent Adverse Events
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| IRCCS San Raffaele Roma | Roma | RM | Recruiting |
More IRCCS San Raffaele Roma trials in Italy
Other trials for the same condition
(Italian Migraine Registry, I-GRAINE-NEW)
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05570149 on ClinicalTrials.gov ↗ ← All trials in Italy