Eptinezumab for Migraine

Recruiting at 28 trial locations

Overseen By Email contact via H. Lundbeck A/S

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: H. Lundbeck A/S

Must be taking: Anti-CGRP mAb, Gepants

Must not be taking: Eptinezumab

Disqualifiers: Cancer, Prostate issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if eptinezumab can improve outcomes for people with migraines, particularly those who have not found success with other treatments. Eptinezumab, administered through an IV, targets migraine symptoms. The trial includes participants who have experienced migraines for at least a year, have them on eight or more days a month, and have not found sufficient relief with other preventive medications. As a Phase 4 trial, eptinezumab is already FDA-approved and proven effective, and this research seeks to understand its benefits for a broader patient population.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions restrictions on the use of certain migraine medications like ubrogepant and rimegepant before and during the trial.

What is the safety track record for eptinezumab?

Research has shown that eptinezumab is generally well-tolerated by people with migraines. In studies, 2,076 patients received at least one dose, covering a total of 1,615 years of use. This extensive data set helps researchers understand the treatment's long-term effects.

Common side effects include reactions at the injection site and cold-like symptoms. Although serious allergic reactions have been reported, they are rare and can occur shortly after treatment.

Overall, many people have used the treatment safely. However, awareness of possible allergic reactions is important. Always discuss any concerns with a healthcare provider. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Eptinezumab is unique because it is a monoclonal antibody that targets the calcitonin gene-related peptide (CGRP) pathway, which plays a key role in migraine development. Unlike other treatments for migraines that might require daily intake, eptinezumab is administered intravenously every three months, offering convenience and potentially increasing adherence. Researchers are excited about this treatment because it can offer rapid onset of migraine prevention, with some patients experiencing relief as soon as one day after infusion, which is faster than many other current migraine therapies.

What is the effectiveness track record for eptinezumab in treating migraines?

Research shows that eptinezumab, which participants in this trial will receive, can help reduce the number of migraine days for many people. In earlier studies, about half of the patients saw their monthly migraine days cut in half. Another study found that those who took eptinezumab experienced about eight fewer migraine days each month. Additionally, people using eptinezumab reported not only fewer migraines but also an improved quality of daily life. This medication works quickly and provides long-lasting relief from migraines. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals who suffer from migraines and haven't found relief with previous anti-CGRP medications. Specific criteria to join or reasons that might disqualify someone are not provided.

Inclusion Criteria

I have been diagnosed with migraines for at least a year.

I have tried a migraine prevention medication without success.

I have had 8 or more migraine days each month for the last 3 months.

Exclusion Criteria

I have been treated with eptinezumab before.

I have tried more than one CGRP-targeting therapy for migraine prevention without success.

I have had cancer other than minor skin cancer or treated cervical issues, not in remission for over 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive eptinezumab at Baseline (Day 1) and Week 12

12 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Eptinezumab

Trial Overview

The study is testing Eptinezumab, a medication aimed at improving symptoms and life quality in migraine sufferers who didn't respond well to prior CGRP-targeting treatments.

How Is the Trial Designed?

Group I: Eptinezumab Experimental Treatment 1 Intervention

Participants will receive eptinezumab at Baseline (Day 1) and Week 12

Eptinezumab is already approved in United States for the following indications:

Approved in United States as Vyepti for:

• Preventive treatment of migraine in adults

Who Is Running the Clinical Trial?

H. Lundbeck A/S

Lead Sponsor

Trials

332

Recruited

78,300+

Charl van Zyl

H. Lundbeck A/S

Chief Executive Officer since 2023

Degree in Medical Biochemistry from the University of Cape Town, South Africa

Johan Luthman

H. Lundbeck A/S

Chief Medical Officer since 2019

MD from the University of Gothenburg, Sweden

Published Research Related to This Trial

A 63-year-old man with rheumatoid arthritis developed multifocal encephalopathy and limbic encephalitis after receiving tocilizumab, an anti-interleukin-6 receptor therapy.

The presence of anti-glutamate receptor ε2 antibodies in both serum and cerebrospinal fluid suggests that tocilizumab may trigger autoimmune responses leading to encephalopathy, highlighting a potential safety concern with this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multifocal encephalopathy and autoimmune-mediated limbic encephalitis following tocilizumab therapy. Yamaguchi, Y., Furukawa, K., Yamamoto, T., et al.[2019]

In a case series of four patients with juvenile idiopathic arthritis (JIA) and severe uveitis, treatment with JAK inhibitors (baricitinib and tofacitinib) led to significant improvement in uveitis, as indicated by reduced intraocular inflammation.

The treatment was well tolerated with no reported ocular discomfort or systemic side effects, suggesting that JAK inhibitors could be a promising option for patients with JIA-associated uveitis who do not respond to conventional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

JAK inhibitors in refractory juvenile idiopathic arthritis-associated uveitis. Miserocchi, E., Giuffrè, C., Cornalba, M., et al.[2021]

In a study of 257 patients with juvenile myoclonic epilepsy (JME), levetiracetam (LEV) has become the most commonly chosen initial antiseizure medication (ASM), surpassing valproic acid (VPA) in recent years, particularly among girls.

While LEV is preferred for its better adverse effect profile, VPA remains more effective in achieving seizure control, with 92.2% of patients being seizure-free for at least 12 months during the follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in the choice of antiseizure medications in juvenile myoclonic epilepsy: A retrospective multi-center study from Turkey between 2010 and 2020. Kılıç, B., Serdaroğlu, E., Polat, BG., et al.[2022]

Eptinezumab is a humanized monoclonal antibody that effectively blocks the action of calcitonin gene-related peptide (CGRP), a key player in migraine development, making it a targeted treatment for migraine prevention.

Approved in February 2020 for adults, eptinezumab is administered intravenously and represents a significant advancement in migraine therapy, highlighting its efficacy in preventing migraine attacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eptinezumab: First Approval. Dhillon, S.[2022]

Eptinezumab, administered as a 300 mg intravenous treatment every 12 weeks, showed a favorable safety profile in a 2-year study involving 128 adults with chronic migraine, with only a 6.3% discontinuation rate due to adverse events.

Patients reported early and sustained improvements in migraine-related symptoms and overall quality of life, with benefits observed as early as 4 weeks and maintained through the end of the study at week 104.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety and tolerability of eptinezumab in patients with chronic migraine: a 2-year, open-label, phase 3 trial. Kudrow, D., Cady, RK., Allan, B., et al.[2021]

Eptinezumab significantly reduced the mean monthly migraine days in adults with two-to-four previous preventive treatment failures, showing a reduction of -2.7 days for the 100 mg dose and -3.2 days for the 300 mg dose compared to placebo, indicating its efficacy as a preventive treatment.

The safety profile of eptinezumab was acceptable, with treatment-emergent adverse events occurring in 42% of the 100 mg group and 41% of the 300 mg group, similar to the 40% in the placebo group, suggesting it is well-tolerated among patients with a history of treatment failures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of eptinezumab for migraine prevention in patients with two-to-four previous preventive treatment failures (DELIVER): a multi-arm, randomised, double-blind, placebo-controlled, phase 3b trial. Ashina, M., Lanteri-Minet, M., Pozo-Rosich, P., et al.[2022]

Efalizumab is an effective treatment for moderate-to-severe psoriasis, with 19,000 patients treated and common mild-to-moderate side effects like headache and chills, particularly after the first two doses.

Serious adverse effects are rare but can include immune-mediated thrombocytopenia and other severe reactions; monitoring of platelet counts is recommended, highlighting the need for careful patient management during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efalizumab: a review of events reported during clinical trials and side effects. Scheinfeld, N.[2019]

Eptinezumab (Vyepti) is an effective preventive treatment for migraines, showing benefits from day 1 and maintaining efficacy for up to a year at doses of 100 mg and 300 mg, with no drug interactions reported.

The safety profile of eptinezumab is favorable, with low frequency of treatment-related adverse events, primarily mild conditions like nasopharyngitis and upper respiratory infections, and it is safe for patients with comorbidities such as obesity and type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Eptinezumab Use in Migraine. Datta, A., Maryala, S., John, R.[2023]

Eptinezumab, a newly approved treatment for migraines, significantly reduces monthly migraine days by about 4 days for episodic migraine and 8 days for chronic migraine compared to placebo, with a low number needed to treat of 6.

The treatment has a quick onset of action, showing effects as soon as one day after infusion, and is generally well-tolerated, with nausea and fatigue being the most common side effects and a low incidence of serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eptinezumab: A calcitonin gene-related peptide monoclonal antibody infusion for migraine prevention. Morgan, KW., Joyner, KR.[2021]

Valproate is the preferred first-line treatment for juvenile myoclonic epilepsy (JME) in men, while lamotrigine is recommended for women due to concerns about valproate's teratogenic effects.

Levetiracetam is also effective and may soon be considered a first-line treatment, but it's important to note that some antiepileptic drugs can worsen JME, and lifelong treatment is typically necessary to prevent seizure recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of juvenile myoclonic epilepsy. Auvin, S.[2021]

Citations

1.

vyeptihcp.com

vyeptihcp.com/efficacy-and-patient-outcomes

Efficacy & Patient Outcomes | VYEPTI® (eptinezumab-jjmr)

Review efficacy data from the VYEPTI pivotal trials · PRIMARY ENDPOINT · 75% FEWER MIGRAINE DAYS · FAST ONSET, SUSTAINED PREVENTION · REDUCTION IN ACUTE MED USE.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12573807/

A prospective real-world analysis of intravenous eptinezumab ...

Clinical trials have shown the safety and statistical superiority of intravenous eptinezumab to placebo in migraine prevention in adults.

3.

prnewswire.com

prnewswire.com/news-releases/lundbeck-showcases-new-clinical-migraine-data-including-long-term-preventive-effectiveness-of-vyepti-eptinezumab-in-patients-severely-impacted-by-migraine-302553629.html

Lundbeck showcases new clinical migraine data, including ...

Around 50% of patients achieved a ≥50% reduction from baseline in monthly migraine days (MMDs) and achieved approximately nine days fewer MMDs ...

4.

vyepti.com

vyepti.com/vyepti-study-results

Clinical Study Results for VYEPTI® IV Migraine Treatment

People with chronic migraine who averaged 16 migraine days a month receiving VYEPTI had an average of 8 fewer migraine days a month vs 6 with placebo, over 3 ...

5.

thejournalofheadacheandpain.biomedcentral.com

thejournalofheadacheandpain.biomedcentral.com/articles/10.1186/s10194-023-01688-w

Long-term effectiveness of eptinezumab in patients with ...

Improvements in patient-reported outcomes indicate that patients perceived benefits beyond reduced migraine frequency and acute medication use ...

6.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2020/761119s000lbl.pdf

VYEPTI (eptinezumab-jjmr) - accessdata.fda.gov

The safety of VYEPTI was evaluated in 2076 patients with migraine who received at least one dose of VYEPTI, representing 1615 patient-years of exposure; of ...

7.

vyeptihcp.com

vyeptihcp.com/safety-and-tolerability

VYEPTI Safety Profile & Tolerability

Learn about VYEPTI safety results from both pivotal trials, the long-term, open-label safety and tolerability study, and common adverse reactions.

8.

nature.com

nature.com/articles/s41598-025-09490-1

Comprehensive safety analysis of adverse events ...

FAERS data identified 5,306 adverse event (AE) reports, with “drug ineffective” (ROR = 6.71) and “migraine” (ROR = 67.45) as the strongest ...

9.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35716692/

Safety and efficacy of eptinezumab for migraine prevention ...

Treatment-emergent adverse events occurred in 127 (42%) of 299 patients in the eptinezumab 100 mg group, in 120 (41%) of 294 in the eptinezumab 300 mg group, ...

10.

ema.europa.eu

ema.europa.eu/en/documents/product-information/vyepti-epar-product-information_en.pdf

Vyepti, eptinezumab - European Medicines Agency

Serious hypersensitivity reactions, including anaphylactic reactions, have been reported and may develop within minutes of the infusion.