Clinical trial NCT06428838: Eptinezumab as an Adjunct to Standard of Care for Migraine in an Acute Emergency Context
Official title: Eptinezumab as an Adjunct to Standard of Care for MIGRANE in an Acute EmeRgency Context (Migraine ERase Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Migraine
Chronic Migraine
Keywords: acute treatment
emergency
monoclonal antibody
Lead sponsor: HealthTech Connex Inc.
Sponsor class: INDUSTRY
Collaborators: name: H. Lundbeck A/S
name: Centre for Neurology Studies, Surrey Neuroplasticity Clinic Inc.
name: Royal Columbian Hospital Foundation
name: Surrey Memorial Hospital
First posted: 2024-05-24
Enrollment: 102
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized (1:1), controlled trial with standard of care (SoC) as control arm.
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Adults between the ages of 19-75 with a history of migraines, as established at the time of presentation to the ED or known from the patient's chart;
2. Presenting to the emergency department with a migraine that meets ICHD-3 migraine headache criteria;
3. Provided signed informed consent;
4. Sufficient literacy and cognitive capacity to understand and complete patient self-rated questionnaires in English.

Exclusion Criteria:

1. Secondary headaches caused by an injury or underlying illness, such as a concussion, bleeding in the brain, an infection or a brain tumor
2. Current or history of severe cardiovascular disease or renal dysfunction
3. A systemic condition in the stage of active treatment (vasculitis, etc.)
4. Pregnant or at risk of becoming pregnant (absent contraception)
5. Currently enrolled in another investigational drug trial
6. Dosed with eptinezumab within the past 3 months
7. Currently on anti-CGRP therapy with monoclonal antibodies
8. Currently involved in active litigation
9. Any other condition which, in the opinion of the Investigator, would exclude the participant due to reasons of safety or data integrity
10. Hypersensitivity to the active substance or to any of the excipients

Primary outcomes:
measure: Number of migraine days at week 1
timeFrame: Baseline to Week 1
Secondary outcomes:
measure: Readmission to the Emergency Department (ED)
timeFrame: Baseline to Month 3
measure: Generalized Anxiety Disorder 7-item (GAD-7)
timeFrame: Baseline to Month 3
measure: Headache Impact Test (HIT-6)
timeFrame: Baseline to Month 3
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline to Month 3
measure: Patient Global Impression of Change (PGI-C)
timeFrame: Baseline to Month 3
measure: Number of monthly headache days
timeFrame: Baseline to Month 3
measure: Migraine recurrence
timeFrame: Baseline to Month 3
measure: Work Productivity and Activity Impairment (WPAI)
timeFrame: Baseline to Month 3
measure: Sleep Quality
timeFrame: Baseline to Month 3
Other outcomes:
Locations:
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
city: Surrey
country: Canada
facility: Surrey Memorial Hospital
state: British Columbia
Study officials:
References: