MigrainePhase 3NCT06428838
Eptinezumab as an Adjunct to Standard of Care for Migraine in an Acute Emergency Context
A Phase 3 study testing Eptinezumab in people with Migraine and Chronic Migraine, run by Dr George Medvedev at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Migraine, Chronic Migraine
- What is being tested?
- Eptinezumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesCanada
- Study dates
- 5 May 2025to Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- Presenting to the emergency department with a migraine that meets ICHD-3 migraine headache criteria;
- Provided signed informed consent;
- Sufficient literacy and cognitive capacity to understand and complete patient self-rated questionnaires in English.
Who cannot join
- Secondary headaches caused by an injury or underlying illness, such as a concussion, bleeding in the brain, an infection or a brain tumor
- Current or history of severe cardiovascular disease or renal dysfunction
- A systemic condition in the stage of active treatment (vasculitis, etc.)
- Pregnant or at risk of becoming pregnant (absent contraception)
- Currently enrolled in another investigational drug trial
- Dosed with eptinezumab within the past 3 months
Show all 10Show fewer
- Currently on anti-CGRP therapy with monoclonal antibodies
- Currently involved in active litigation
- Any other condition which, in the opinion of the Investigator, would exclude the participant due to reasons of safety or data integrity
- Hypersensitivity to the active substance or to any of the excipients
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites
Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W7
Surrey Memorial Hospital
Surrey, British Columbia, V3V 1Z2
About this study
Official title: Eptinezumab as an Adjunct to Standard of Care for MIGRANE in an Acute EmeRgency Context (Migraine ERase Study)
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.
Read more
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
- Being tested
- Eptinezumab, Standard of Care
- Keywords
- acute treatment, emergency, monoclonal antibody
- Medical subject headings
- Migraine Disorders, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EptinezumabBiological
The study treatment consists of a single infusion of eptinezumab (100mg/mL).
Standard of CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Other | SoC will be delivered at the discretion of the treating physician Receives: Other: Standard of Care |
| Standard of Care + Eptinezumab | Experimental | In addition to standard of care, participants randomized to the Standard of Care + Eptinezumab arm will receive a single infusion of eptinezumab (100mg/mL). Receives: Biological: Eptinezumab; Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of migraine days at week 1
Number of migraine days at week 1, as reported in daily Headache Diary
Measured: Baseline to Week 1
Secondary outcomes (9)
Readmission to the Emergency Department (ED)
Readmission to the Emergency Department (ED) as assessed by patient chart
Measured: Baseline to Month 3
Generalized Anxiety Disorder 7-item (GAD-7)
The Generalized Anxiety Disorder 7-item (GAD-7) will be assessed at baseline, month 1 and month 3. The GAD-7 is a short self-report questionnaire assessing the severity of anxiety disorder. For each item, the participant is asked how bothered they have been by the problem in the last 2 weeks. The total score ranges from 0-21, and a score greater than 15 indicates severe anxiety. The recall period for the GAD-7 is 2 weeks.
Measured: Baseline to Month 3
Headache Impact Test (HIT-6)
The Headache Impact Test (HIT-6) will involve an assessment at baseline and at months 1 and 3. The HIT-6 (v1.0) is a Likert-type, self-reported questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. HIT-6 scores range from 36 to 78. Higher scores indicate a greater impact of headaches on the respondent's life, i.e., 36 = no impact, 78 = maximum impact. The HIT-6 consists of six items: pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. The assessment was developed to measure a wide spectrum of factors contributing to headache burden, and it has demonstrated reliability and validity. The recall period for the HIT-6 is 4 weeks.
Measured: Baseline to Month 3
Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a short self-report questionnaire assessing signs and symptoms of depression. The questionnaire consists of nine items which ask about the frequency and severity of depressive symptoms based on DSM-IV criteria. For each item, the participant is asked to rate the severity of the symptom on a scale from 0 to 3. The total score ranges from 0-27 with a higher score indicating more severe depressive symptoms. The recall period for the PHQ-9 is 2 weeks.
Measured: Baseline to Month 3
Patient Global Impression of Change (PGI-C)
The PGI-C will involve an assessment at 24-72hrs, week 1, month 1 and month 3. PGI-C is a one-item measure rating of the overall patient perceived improvement on a seven-point scale. Patients rate their change since treatment initiation as "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", or "very much worse.
Measured: Baseline to Month 3
Number of monthly headache days
Number of monthly headache days as assessed by the Migraine Disability Assessment (MIDAS)
Measured: Baseline to Month 3
Migraine recurrence
Recurrence of migraine as reported in daily Headache Diary
Measured: Baseline to Month 3
Work Productivity and Activity Impairment (WPAI)
The WPAI is a six-item validated instrument that measures aspects of work productivity and activity impairment due to migraine over the past 7 days with higher values, in the form of percentages, indicating greater impairment due to the respondent's health. Only patients that are currently employed (full-time, part-time, or self-employed) are eligible to respond to the items assessing work-related activities. Item 6 in the WPAI will be administered to those not in employment, providing the possibility of calculating activity impairment for patients that are not employed. The six items are used to derive four subscales: Absenteeism (proportion of missed work hours out of the total; scale 0-100%), Presenteeism (level of work impairment; scale 0-10), Overall work impairment (combination of absenteeism and presenteeism; scale 0-100%), and Activity impairment (impairment in daily activities; scale 0-10).
Measured: Baseline to Month 3
Sleep Quality
Sleep quality will be assessed with the question, "On average, about how many hours of sleep do you get per night?" with responses including "7-9 hrs", "6-6.9 hrs", "5-5.9 hrs" or "less than 5 hrs". The recall period will be 1 week.
Measured: Baseline to Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start5 May 2025
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized (1:1), controlled trial with standard of care (SoC) as control arm.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr George Medvedev
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- H. Lundbeck A/S, Royal Columbian Hospital Foundation, Surrey Memorial Hospital (SMH), Centre for Neurology Studies, Canada
- Responsible party
- Sponsor-investigator, Dr George Medvedev, HealthTech Connex Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428838
- Sponsor's protocol ID
- Medvedev_001
- Status last verified
- Sep 2026
- First submitted
- 16 May 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If the results of the study are published in the public domain, only aggregate/group data will be published.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eptinezumab as an Adjunct to Standard of Care for MIGRANE in an Acute EmeRgency Context (Migraine ERase Study)
- ClinicalTrials.gov ID
- NCT06428838
- Acronym / sponsor ID
- Medvedev_001
- Conditions
- Migraine, Chronic Migraine
- Keywords
- acute treatment, emergency, monoclonal antibody
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Dr George MedvedevIndustry (pharma, biotech, devices)
- Collaborators
- H. Lundbeck A/S, Royal Columbian Hospital Foundation, Surrey Memorial Hospital (SMH), Centre for Neurology Studies, Canada
- Study start
- 5 May 2025 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized (1:1), controlled trial with standard of care (SoC) as control arm.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Other | Other: Standard of CareSoC will be delivered at the discretion of the treating physician |
| Standard of Care + Eptinezumab | Experimental | Biological: Eptinezumab, Other: Standard of CareIn addition to standard of care, participants randomized to the Standard of Care + Eptinezumab arm will receive a single infusion of eptinezumab (100mg/mL). |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
- Presenting to the emergency department with a migraine that meets ICHD-3 migraine headache criteria;
- Provided signed informed consent;
- Sufficient literacy and cognitive capacity to understand and complete patient self-rated questionnaires in English.
Key exclusion criteria (10 listed)
- Secondary headaches caused by an injury or underlying illness, such as a concussion, bleeding in the brain, an infection or a brain tumor
- Current or history of severe cardiovascular disease or renal dysfunction
- A systemic condition in the stage of active treatment (vasculitis, etc.)
- Pregnant or at risk of becoming pregnant (absent contraception)
- Currently enrolled in another investigational drug trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EptinezumabThe study treatment consists of a single infusion of eptinezumab (100mg/mL). | Biological | Standard of Care + Eptinezumab |
| Standard of CareSoC 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. | Other | Standard of Care, Standard of Care + Eptinezumab |
Primary outcome
Number of migraine days at week 1
Time frame: Baseline to Week 1
Number of migraine days at week 1, as reported in daily Headache Diary
9 secondary outcomes
Readmission to the Emergency Department (ED)
Time frame: Baseline to Month 3
Generalized Anxiety Disorder 7-item (GAD-7)
Time frame: Baseline to Month 3
Headache Impact Test (HIT-6)
Time frame: Baseline to Month 3
Patient Health Questionnaire (PHQ-9)
Time frame: Baseline to Month 3
Patient Global Impression of Change (PGI-C)
Time frame: Baseline to Month 3
Number of monthly headache days
Time frame: Baseline to Month 3
Migraine recurrence
Time frame: Baseline to Month 3
Work Productivity and Activity Impairment (WPAI)
Time frame: Baseline to Month 3
Sleep Quality
Time frame: Baseline to Month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No. If the results of the study are published in the public domain, only aggregate/group data will be published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eptinezumab in people with Migraine and Chronic Migraine, run by Dr George Medvedev at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of migraine days at week 1 (time frame: Baseline to Week 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.