NCT06428838

Eptinezumab as an Adjunct to Standard of Care for Migraine in an Acute Emergency Context

Eptinezumab as an Adjunct to Standard of Care for MIGRANE in an Acute EmeRgency Context (Migraine ERase Study)

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Dr George Medvedev · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to investigate how a medication called eptinezumab (Vyepti) given to patients in the Emergency Department (ED) might help prevent migraines from happening again. The results of this study may help inform better ways to manage patients with migraines in the ED. Eptinezumab is currently approved by Health Canada for the preventive treatment of migraine, but its short-term effectiveness in the ED context is unknown. Unlike other migraine treatments used in the ED, eptinezumab can rapidly interrupt the migraine process, potentially also preventing migraine from coming back in the short term. Most patients with a diagnosis of migraine have no access to preventative therapies. This study will be able to provide access to preventative therapy at the earliest stages of a migraine attack. Administering this medication in the ED may stop the attack more effectively compared to current therapies. This study wants to see if eptinezumab could help stop migraines from coming back after individuals have been treated in the ED. The study will also explore whether eptinezumab could reduce how often individuals with migraine might need to come back to the ED, what other medications they might need alongside eptinezumab, and how they feel overall.

Conditions

• Migraine
• Chronic Migraine

Interventions

Type	Name	Description
BIOLOGICAL	Eptinezumab	The study treatment consists of a single infusion of eptinezumab (100mg/mL).
OTHER	Standard of Care	SoC may include a combination of Toradol, Metoclopramide, and/or Benadryl. Ketamine and/or Midazolam may also be used, according to a stepwise approach, at the discretion of the treating physician. The timing and dose of all medication(s) administered in the ED will be recorded.

Timeline

• Start date: 2024-09-30
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2024-05-24
• Last updated: 2024-05-24

Locations

2 sites across 1 country: Canada