Migraine
Conditions
Keywords
headache, Pain, migraine, Eptinezumab
Brief summary
A perspective and multicentric study to evaluate the efficacy of eptinezumab administered during a migraine attack. During the intravenous infusion of eptinezumab, some patients experiencing an ongoing migraine attack report its resolution. This finding is known in the literature, having been described in the RELIEF study. This study was designed to also evaluate, in a real-world setting, the efficacy of eptinezumab in resolving the ongoing attack and the time frame within which the attack is resolved. The study includes all patients who will begin treatment according to clinical practice, and are included in the TACHIS study (NCT06409845, Unique protocol ID RICe\_5)
Interventions
Eptinezumab administered for migraine prevention in patients but with ongoing migraine attacks.
Sponsors
University of Florence
Società Italiana per lo Studio delle Cefalee
Fondazione Policlinico Universitario Campus Bio-Medico
SISC RICe Group
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of migraine without aura, migraine with aura, or chronic migraine according to the third edition of the ICHD (ICHD-III). * At least 8 days of migraine per month. * Adequate compliance with study procedures. * Availability of a migraine diary for at least one month prior to enrollment. * Ongoing attack before administration. * Included in the TACHIS study (NCT06409845)
Exclusion criteria
* Subjects with contraindications to the use of eptinezumab. * Concomitant diagnosis of medical conditions and/or comorbidities that, in the investigator's opinion, could interfere with the study's assessments and outcomes. * Pregnancy and breastfeeding. * Changes in concomitant preventive therapy in the month prior to the initiation of eptinezumab.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Headache Pain Freedom | Up to 48 hours postdose | Time to headache pain freedom defined as the time that the participant reported freedom of pain, meaning their headache pain had gone from moderate to severe at baseline to no pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Absence of Most Bothersome Symptom (MBS) | Up to 48 hours postdose | Time to absence of most bothersome symptom defined as the time that the participant reported absence of MBS |
| Headache Pain Freedom at 2 Hours | 2 hours | Number of participants with freedom from headache pain at 2 hours postdose are reported. |
| Absence of MBS at 2 Hours | 2 hours | Number of participants with absence of MBS (of nausea, photophobia, or phonophobia) at 2 hours postdose are reported. |
| Headache Pain Freedom and absence of MBS | Up to 48 hours postdose | Number of participants with freedom from headache pain and/or Number of participants with absence of MBS up to 48 hours |
| Use of Rescue Medication | Up to 48 hours postdose | Number of participants who used rescue medication up to 48 hours post dose |
Countries
Italy
Contacts
CONTACTFabrizio Vernieri, MD
Outcome results
None listed