What side effects are associated with this type of intervention?

Common treatments for migraines that target CGRP, such as Eptinezumab, Fremanezumab, and Galcanezumab, generally have side effects including injection site reactions, constipation, and potential cardiovascular risks like hypertension. Other treatments like triptans, which are used for acute migraine relief, can cause side effects such as nausea, dizziness, and fatigue. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

The FDA has approved several treatments for migraine that target the calcitonin gene-related peptide (CGRP) pathway, similar to Eptinezumab. These include Erenumab (Aimovig), Fremanezumab (Ajovy), and Galcanezumab (Emgality). These medications work by inhibiting the activity of CGRP, a neuropeptide involved in migraine pathophysiology, thereby reducing the frequency and severity of migraine attacks.

What other types of research exist?

Promising alternatives to Eptinezumab for migraine treatment include other CGRP-targeted monoclonal antibodies such as Erenumab, Fremanezumab, and Galcanezumab. Additionally, Gepants (CGRP receptor antagonists) like Atogepant and Rimegepant are emerging as effective options. Non-CGRP options include OnabotulinumtoxinA for chronic migraine and neuromodulation devices like transcranial magnetic stimulation (TMS). These alternatives have shown efficacy in reducing migraine frequency and improving patient outcomes.

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Monoclonal Antibodies

Eptinezumab for Migraine

Phase 4

Waitlist Available

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 ≥8 migraine days per month for each month within the past 3 months prior to the Screening Visit.

Must not have

The participant has a diagnosis of acute or active temporomandibular disorders.

The participant has a history or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), recurrent painful ophthalmoplegic neuropathy, migraine with brainstem aura, and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 1-12 and weeks 13-24

Awards & highlights

All Individual Drugs Already Approved

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is testing eptinezumab, a medication that prevents migraines, in adults who have migraines and medication overuse headaches. The goal is to see if it can reduce the number of days with migraines and headaches, and lower the use of other headache medications. The study lasts several months and includes different phases to monitor safety and effectiveness.

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.

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.

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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a jaw joint disorder.

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I have been diagnosed with a specific type of severe or unusual headache.

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I have a significant pain condition like fibromyalgia or chronic back pain.

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I have a history of serious heart or blood vessel problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 1-12 and weeks 13-24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 1-12 and weeks 13-24

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1-12 and weeks 13-24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change From Baseline in Health Care Resources Utilisation (HCRU) Score

Anxiety

Change From Baseline in Treatment Satisfaction Questionnaire for Medicine (9 Items) (TSQM-9) Score

+7 more

Side effects data

From 2020 Phase 3 trial • 485 Patients • NCT04152083

Hypersensitivity

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Eptinezumab

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Migraine treatments work through various mechanisms to alleviate or prevent headache symptoms. Eptinezumab, a CGRP antagonist, prevents migraines by inhibiting the activity of calcitonin gene-related peptide (CGRP), a molecule involved in migraine pathophysiology. Triptans, another common treatment, activate serotonin receptors (5-HT1B/1D) to constrict blood vessels and reduce inflammation. NSAIDs, like diclofenac and acetaminophen, inhibit cyclooxygenase enzymes (COX-1 and COX-2) to reduce inflammation and pain. Understanding these mechanisms is crucial for migraine patients as it helps tailor treatments to their specific needs, improving efficacy and reducing the frequency and severity of migraine attacks.