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| Name | Class |
|---|---|
| Società Italiana per lo Studio delle Cefalee | OTHER |
| Fondazione Policlinico Universitario Campus Bio-Medico | OTHER |
| SISC RICe Group | UNKNOWN |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Episodic migraine | Patients affected by migraine with an episodic pattern (< 15 monthly migraine days) with or without aura according to ICHD-III criteria with ongoing migraine attack. |
| |
| Chronic migraine | Group/Cohort Description: atients affected by chronic migraine (> 15 monthly headache days with at least 8 days with migraine features) according to ICHD-III criteria with ongoing migraine attack. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eptinezumab 100 or 300 mg ev | Drug | Eptinezumab administered for migraine prevention in patients but with ongoing migraine attacks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Headache Pain Freedom | 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. | Up to 48 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Absence of Most Bothersome Symptom (MBS) | Time to absence of most bothersome symptom defined as the time that the participant reported absence of MBS | Up to 48 hours postdose |
| Headache Pain Freedom at 2 Hours |
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Inclusion Criteria:
Exclusion Criteria:
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Multicentric study on patients attending the outpatient clinic of Italian Headache centres who meet criteria for eptinezumab use as migraine preventive treatment
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fabrizio Vernieri, MD | Contact | 06 225411 | F.Vernieri@policlinicocampus.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Campus Biomedico | Recruiting | Roma | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34128999 | Background | Winner PK, McAllister P, Chakhava G, Ailani J, Ettrup A, Krog Josiassen M, Lindsten A, Mehta L, Cady R. Effects of Intravenous Eptinezumab vs Placebo on Headache Pain and Most Bothersome Symptom When Initiated During a Migraine Attack: A Randomized Clinical Trial. JAMA. 2021 Jun 15;325(23):2348-2356. doi: 10.1001/jama.2021.7665. |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| D010146 | Pain |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C000628361 | eptinezumab |
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Number of participants with freedom from headache pain at 2 hours postdose are reported.
| 2 hours |
| Absence of MBS at 2 Hours | Number of participants with absence of MBS (of nausea, photophobia, or phonophobia) at 2 hours postdose are reported. | 2 hours |
| Headache Pain Freedom and absence of MBS | Number of participants with freedom from headache pain and/or Number of participants with absence of MBS up to 48 hours | Up to 48 hours postdose |
| Use of Rescue Medication | Number of participants who used rescue medication up to 48 hours post dose | Up to 48 hours postdose |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |