MigrainePhase 4EVECNCT05284019

Real World Effectiveness of Eptinezumab in Participants With Migraine

A Phase 4 study testing Eptinezumab, Erenumab and Onabotulinumtoxin-A in people with Migraine, run by H. Lundbeck A/S at 10 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to examine how eptinezumab compares to other advanced preventive medications in a real-world community setting in adult participants with episodic migraine (EM) or chronic migraine (CM). These objectives include exploring the comparative effectiveness on patient reported outcomes. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Migraine
What is being tested?: Eptinezumab, Erenumab and Onabotulinumtoxin-A
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 10 sitesUnited States
Study dates: 4 Mar 2022to 14 Apr 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have a diagnosis of migraine per International Headache Society (IHS) International Classification of Headache Disorder (ICHD)-3 guidelines at least 12 months prior to screening.
Have a history of ≥ 8 migraine days/month in 2 of the previous 3 months as confirmed by the treating physician through medical records.
Be able to understand the clinical description of treatment options and have the capability to participate fully in making their treatment preferences known.
Be willing to accept randomization to any of the possible study medications if allocated to that treatment arm.
Be willing and capable of completing daily reports and other participant reported outcome measures using a smartphone-based application.

Who cannot join

The participant has a history of severe drug allergy or hypersensitivity, or known hypersensitivity or intolerance to either eptinezumab, erenumab, fremanezumab, galcanezumab or their excipients.
The participant has previous history of use of any of the study drugs (for example, eptinezumab, Botox, erenumab, fremanezumab or galcanezumab). Note that only previous Botox use for treatment of migraine is exclusionary. Prior use of Botox for cosmetic purposes is allowed.
The participant has a diagnosis of CM and has hypersensitivity to botulinum toxin preparation or to any of the components in the formulation.
The participant has used opioids or butalbital-containing products greater than 4 days per month in the last month.
Other inclusion and exclusion criteria may apply.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Dent Neurologic Institute - Amherst
Amherst, New York, 14226
StudyMetrix Research
City of Saint Peters, Missouri, 63303
Carolina Women's Research and Wellness Center
Durham, North Carolina, 27713
Gilbert Neurology Partners/ CCT Research
Gilbert, Arizona, 85297
North Kansas City Hospital
North Kansas City, Missouri, 64416
Innovation Medical Group
Palmetto Bay, Florida, 33157
AIM Trials, LLC
Plano, Texas, 75093
The Headache Center
Ridgeland, Mississippi, 39157
Olympus Family Medicine/CCT Research
Salt Lake City, Utah, 84117
Ki Clinical Research LLC, dba New England Institute for Clinical Research
Stamford, Connecticut, 06905

Other trials in United States

About this study

Official title: An Exploratory, Prospective, Randomized, Pragmatic Open Label Cohort Study to Evaluate the Comparative Effectiveness of Eptinezumab in the United States

Conditions: Migraine
Being tested: Eptinezumab, Erenumab, Onabotulinumtoxin-A, Fremanezumab, Galcanezumab
Medical subject headings: Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EptinezumabDrug
Also called Vyepti
Concentrate for solution for IV infusion
ErenumabDrug
Also called Aimovig®
Solution for SC Injection
Onabotulinumtoxin-ADrug
Solution for IM Injection
FremanezumabDrug
Also called Ajovy®
Solution for SC Injection
GalcanezumabDrug
Also called Emgality®
Solution for SC Injection

Study groups in NCT05284019
Study group	Role	What they receive
Eptinezumab	Experimental	Participants will receive eptinezumab via intravenous (IV) infusion on Day 0 and Day 84. Receives: Drug: Eptinezumab
Anti-CGRP injectables	Experimental	Participants are free to select treatment from one of 3 calcitonin gene-related peptide (CGRP) inhibitors: erenumab, fremanezumab, or galcanezumab. CGRP inhibitors will be administered via subcutaneous (SC) injection on Day 0 and then, per product label. Receives: Drug: Erenumab; Drug: Fremanezumab; Drug: Galcanezumab
Onabotulinumtoxin-A	Experimental	Onabotulinumtoxin-A will be administered via intramuscular (IM) injection on Day 0 and Day 84. Receives: Drug: Onabotulinumtoxin-A

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Patient-informed Most Bothersome Symptom (PI-MBS) Score at Week 24
Participants select the symptom that they find most impairs them at the time of reporting and rate the severity of that symptom on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a high score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status. The MBS areas included: nausea, vomiting, sensitivity to light, sensitivity to sound, mental cloudiness, fatigue, pain with activity, mood changes, and other symptoms.
Measured: Baseline, Week 24
Number of "Good Days" From Baseline
The participants report the number of "good days" and "bad days" they had in the previous week on a weekly basis using the good day/bad day scale.
Measured: Up to Week 24
Change From Baseline in Quality of Life (QOL) as Measured by the 5 Level Euro Quality of Life 5 Dimensional Questionnaire (EQ-5D-5L) Score at Week 24
The EQ-5D-5L is a participant-reported assessment designed to measure the participant's well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a visual analog scale (VAS) of the overall health state. Each descriptive item is rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
Measured: Baseline, Week 24
Health Care Resources Utilization (HCRU): Number of Participants Who Used Health Services and Medications
Measured: Up to Week 24
QOL as Measured by the 6 Item Headache Impact Test (HIT-6) Score
The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item is rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 is the sum of each response score ranging from 36 to 78. The life impact derived from the total score is described as follows: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).
Measured: Up to Week 24
QOL as Measured by the Migraine Disability Assessment (MIDAS) Total Score
The Midas score is a participant completed 5-item questionnaire about lost time and productivity (for work, school or family/social activities) in the past 3 months (number of days missed) where: 0-5=Little or No disability, 6-10=Mild disability, 11-20=Moderate disability or 21+ Severe disability.
Measured: Up to Week 24
Participant Satisfaction Score as Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)
The TSQM assesses four domains of participants' satisfaction with treatment, with scale ranges from 0 (extremely dissatisfied) to 100 (not at all dissatisfied) for each of the categories (Effectiveness, Side Effects, Convenience, and Overall Satisfaction).
Measured: Week 24
Percentage of Participants That Switch From the Preventive Medication They Are Randomized to at Baseline to Another Preventive Medication
Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Mar 202214 Apr 2023

First posted17 Mar 2022
Study start4 Mar 2022
Primary completion17 Feb 2023
Study completion14 Apr 2023

Why it stopped: The study was terminated due to enrolment challenges.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for MigraineStudies of the same condition, open and under way.
More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05284019
Sponsor's protocol ID: 19766N
Acronym: EVEC
Status last verified: May 2024
First submitted: 23 Feb 2022
Last updated: 29 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Study of the Glymphatic System in Migraine
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Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
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App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
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Recruiting
Marine Lipids Ease Painful TMD
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All Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Exploratory, Prospective, Randomized, Pragmatic Open Label Cohort Study to Evaluate the Comparative Effectiveness of Eptinezumab in the United States
ClinicalTrials.gov ID: NCT05284019
Acronym / sponsor ID: EVEC / 19766N
Conditions: Migraine
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated due to enrolment challenges.
Enrolment: 32 participants (actual)
Lead sponsor: H. Lundbeck A/SIndustry (pharma, biotech, devices)
Study start: 4 Mar 2022 (actual)
Primary completion: 17 Feb 2023 (actual)
Study completion: 14 Apr 2023 (actual)
First posted: 17 Mar 2022 (actual)
Results: Posted 29 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Eptinezumab	Experimental	Drug: EptinezumabParticipants will receive eptinezumab via intravenous (IV) infusion on Day 0 and Day 84.
Anti-CGRP injectables	Experimental	Drug: Erenumab, Drug: Fremanezumab, Drug: GalcanezumabParticipants are free to select treatment from one of 3 calcitonin gene-related peptide (CGRP) inhibitors: erenumab, fremanezumab, or galcanezumab. CGRP inhibitors will be administered via subcutaneous (SC) injection on Day 0 and then, per product label.
Onabotulinumtoxin-A	Experimental	Drug: Onabotulinumtoxin-AOnabotulinumtoxin-A will be administered via intramuscular (IM) injection on Day 0 and Day 84.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Have a diagnosis of migraine per International Headache Society (IHS) International Classification of Headache Disorder (ICHD)-3 guidelines at least 12 months prior to screening.
Have a history of ≥ 8 migraine days/month in 2 of the previous 3 months as confirmed by the treating physician through medical records.
Be able to understand the clinical description of treatment options and have the capability to participate fully in making their treatment preferences known.
Be willing to accept randomization to any of the possible study medications if allocated to that treatment arm.
Be willing and capable of completing daily reports and other participant reported outcome measures using a smartphone-based application.

Key exclusion criteria (5 listed)

The participant has a history of severe drug allergy or hypersensitivity, or known hypersensitivity or intolerance to either eptinezumab, erenumab, fremanezumab, galcanezumab or their excipients.
The participant has previous history of use of any of the study drugs (for example, eptinezumab, Botox, erenumab, fremanezumab or galcanezumab). Note that only previous Botox use for treatment of migraine is exclusionary. Prior use of Botox for cosmetic purposes is allowed.
The participant has a diagnosis of CM and has hypersensitivity to botulinum toxin preparation or to any of the components in the formulation.
The participant has used opioids or butalbital-containing products greater than 4 days per month in the last month.
Other inclusion and exclusion criteria may apply.

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
EptinezumabAlso: VyeptiConcentrate for solution for IV infusion	Drug	Eptinezumab
ErenumabAlso: Aimovig®Solution for SC Injection	Drug	Anti-CGRP injectables
Onabotulinumtoxin-ASolution for IM Injection	Drug	Onabotulinumtoxin-A
FremanezumabAlso: Ajovy®Solution for SC Injection	Drug	Anti-CGRP injectables
GalcanezumabAlso: Emgality®Solution for SC Injection	Drug	Anti-CGRP injectables

Primary outcome

Change From Baseline in Patient-informed Most Bothersome Symptom (PI-MBS) Score at Week 24
Time frame: Baseline, Week 24
Participants select the symptom that they find most impairs them at the time of reporting and rate the severity of that symptom on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a high score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status. The MBS areas included: nausea, vomiting, sensitivity to light, sensitivity to sound, mental cloudiness, fatigue, pain with activity, mood changes, and other symptoms.
Number of "Good Days" From Baseline
Time frame: Up to Week 24
The participants report the number of "good days" and "bad days" they had in the previous week on a weekly basis using the good day/bad day scale.
Change From Baseline in Quality of Life (QOL) as Measured by the 5 Level Euro Quality of Life 5 Dimensional Questionnaire (EQ-5D-5L) Score at Week 24
Time frame: Baseline, Week 24
The EQ-5D-5L is a participant-reported assessment designed to measure the participant's well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a visual analog scale (VAS) of the overall health state. Each descriptive item is rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
Health Care Resources Utilization (HCRU): Number of Participants Who Used Health Services and Medications
Time frame: Up to Week 24
QOL as Measured by the 6 Item Headache Impact Test (HIT-6) Score
Time frame: Up to Week 24
The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item is rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 is the sum of each response score ranging from 36 to 78. The life impact derived from the total score is described as follows: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).
QOL as Measured by the Migraine Disability Assessment (MIDAS) Total Score
Time frame: Up to Week 24
The Midas score is a participant completed 5-item questionnaire about lost time and productivity (for work, school or family/social activities) in the past 3 months (number of days missed) where: 0-5=Little or No disability, 6-10=Mild disability, 11-20=Moderate disability or 21+ Severe disability.
Participant Satisfaction Score as Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)
Time frame: Week 24
The TSQM assesses four domains of participants' satisfaction with treatment, with scale ranges from 0 (extremely dissatisfied) to 100 (not at all dissatisfied) for each of the categories (Effectiveness, Side Effects, Convenience, and Overall Satisfaction).
Percentage of Participants That Switch From the Preventive Medication They Are Randomized to at Baseline to Another Preventive Medication
Time frame: Week 24

Results and safety

Results posted to the registry on 29 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Erenumab	3	0
Fremanezumab	2	0
Onabotulinumtoxin-A	2	0
Galcanezumab	8	0
Eptinezumab	17	0

Primary outcome: Change From Baseline in Patient-informed Most Bothersome Symptom (PI-MBS) Score at Week 24

Time frame: Baseline, Week 24

Population analysed: Analysis was performed on the full analysis set (FAS), which included all participants who completed at least one daily report after receiving eptinezumab or other advanced migraine therapy. Due to the small sample size, data was not reported for participant confidentiality reasons.

Primary outcome: Number of "Good Days" From Baseline

Time frame: Up to Week 24

Population analysed: Analysis was performed on the FAS, which included all participants who completed at least one daily report after receiving eptinezumab or other advanced migraine therapy. Due to the small sample size, data was not reported for participant confidentiality reasons.

Primary outcome: Change From Baseline in Quality of Life (QOL) as Measured by the 5 Level Euro Quality of Life 5 Dimensional Questionnaire (EQ-5D-5L) Score at Week 24

Time frame: Baseline, Week 24

Primary outcome: Health Care Resources Utilization (HCRU): Number of Participants Who Used Health Services and Medications

Time frame: Up to Week 24

Adverse events

Time frame: Baseline up to Week 24. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Erenumab	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Fremanezumab	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Onabotulinumtoxin-A	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Galcanezumab	0 of 8 (0%)	6 of 8 (75%)	0 of 8
Eptinezumab	0 of 16 (0%)	4 of 16 (25%)	0 of 16

Limitations and caveats (from the sponsor): The study was terminated early due to enrolment challenges.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Migraine

RecruitingObservational study
Study of the Glymphatic System in Migraine
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Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
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App-Based Migraine Treatment: The Health enSuite Study
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Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
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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. This study is not recruiting at the moment.

Email contact via H. Lundbeck A/S study director

LundbeckClinicalTrials@Lundbeck.com

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Eptinezumab, Erenumab and Onabotulinumtoxin-A in people with Migraine, run by H. Lundbeck A/S at 10 sites in United States.

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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Patient-informed Most Bothersome Symptom (PI-MBS) Score at Week 24 (time frame: Baseline, Week 24). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05284019.

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 29 May 2024.