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Monoclonal Antibodies

Eptinezumab for Migraine

Phase 4
Recruiting
Research Sponsored by H. Lundbeck A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The participant has had an onset of migraine diagnosis at ≤50 years of age.
The participant has ≥15 headache days per month for each month within the past 3 months prior to the Screening Visit.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on the day after dosing
Awards & highlights

Study Summary

This trial is testing a new medication to see if it can help prevent migraines in adults with MOH.

Who is the study for?
This trial is for adults under 50 with a migraine diagnosis who have had at least 8 migraine days and 15 headache days per month over the last three months. It's not suitable for those with certain pain syndromes, psychiatric conditions not well-controlled or treated in the past six months, unusual migraine subtypes, or significant cardiovascular issues.Check my eligibility
What is being tested?
The study tests if Eptinezumab can reduce migraine frequency, headache days, and acute medication use in adults with migraines and MOH. Participants will either receive Eptinezumab or a placebo to compare outcomes between the two groups.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones associated with similar medications include injection site reactions, allergic responses, fatigue, nausea. Each individual may experience side effects differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was diagnosed with migraines before or at the age of 50.
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I've had 15 or more headache days each month for the last 3 months.
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I have had 8 or more migraine days each month for the last 3 months.
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I've had 15 or more headache days each month for the last 3 months.
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I have been diagnosed with migraine or medication overuse headache.
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I've had 15 or more headache days each month for the last 3 months.
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I've had 15 or more headache days each month for the last 3 months.
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I was diagnosed with migraines before or at the age of 50.
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I have been diagnosed with migraine or medication overuse headache.
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I was diagnosed with migraines before or at the age of 50.
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I have had 8 or more migraine days each month for the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 1-4, weeks 1-12, and weeks 13-24
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1-4, weeks 1-12, and weeks 13-24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in the Number of Monthly Migraine Days (MMDs)
Secondary outcome measures
Change From Baseline in Average Daily Pain Assessment Score
Change From Baseline in Health Care Resources Utilisation (HCRU) Score
Anxiety
+21 more

Side effects data

From 2020 Phase 3 trial • 485 Patients • NCT04152083
2%
Hypersensitivity
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Eptinezumab

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: EptinezumabExperimental Treatment1 Intervention
Participants will receive an intravenous (IV) infusion of eptinezumab at Week 0 and Week 12.
Group II: PlaceboPlacebo Group2 Interventions
Participants will receive a single IV infusion of matching placebo to eptinezumab at Week 0. Then, all participants will receive a single IV infusion of eptinezumab at Week 12.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eptinezumab
FDA approved

Find a Location

Who is running the clinical trial?

H. Lundbeck A/SLead Sponsor
324 Previous Clinical Trials
77,005 Total Patients Enrolled
12 Trials studying Migraine
4,216 Patients Enrolled for Migraine
Email contact via H. Lundbeck A/SStudy DirectorLundbeckClinicalTrials@Lundbeck.com
188 Previous Clinical Trials
57,770 Total Patients Enrolled
11 Trials studying Migraine
3,718 Patients Enrolled for Migraine

Media Library

Eptinezumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05452239 — Phase 4
Migraine Research Study Groups: Eptinezumab, Placebo
Migraine Clinical Trial 2023: Eptinezumab Highlights & Side Effects. Trial Name: NCT05452239 — Phase 4
Eptinezumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05452239 — Phase 4
Migraine Patient Testimony for trial: Trial Name: NCT05452239 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial accept participants who are of age twenty and above?

"This research is inviting individuals aged between 18 and 75 years old to take part in the study."

Answered by AI

How many participants are being included in the study?

"This trial requires 570 eligible patients to take part, who can join at Clinvest Research LLC in Springfield, Missouri and Clinical Research of Central Florida - ClinEdge - PPDS in Winter Haven, Florida."

Answered by AI

Are there still opportunities to join this clinical experiment?

"The clinical trial is actively searching for participants, as evidenced on ClinicalTrials.gov which lists the trial's initial posting date of July 1st 2022 and most recent edit made on November 11th 2022."

Answered by AI

Who is eligible to join this research endeavor?

"To be eligible for this research, potential participants must have been diagnosed with migraine and fall into the age range between 18 to 75 years. Altogether, 570 individuals will be recruited."

Answered by AI

In what geographic areas is this investigation accessible?

"Clinvest Research LLC in Springfield, Missouri, Clinical Research of Central Florida - ClinEdge - PPDS in Winter Haven, Florida and Legacy Clinical Solutions: Tandem Clinical Research, LLC- Clinedge - Louisiana - PPDS in Marrero are the primary locations for this study. There are also 6 other sites where patients can participate."

Answered by AI

What potential adverse reactions should patients be aware of when using Eptinezumab?

"Our team at Power has rated the safety of Eptinezumab as a 3, due to it being approved for use and having gone through numerous phases of clinical trials."

Answered by AI

Who else is applying?

What state do they live in?
Rhode Island
Other
Texas
New York
How old are they?
18 - 65
What site did they apply to?
Texas Center for Drug Development, Inc
Dent Neurologic Institute
Montefiore Headache Center - BRANY - PPDS
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
3+
0

Why did patients apply to this trial?

because I can help other people and I also need the cash. like to find relief from getting migraines and or stop them all together.
PatientReceived no prior treatments
Ive tried 2 prescription Drugs and 3-4 different offer the counter medications.
PatientReceived 2+ prior treatments
~127 spots leftby Oct 2024