Eptinezumab for Migraine

Recruiting at 111 trial locations

Overseen By Email contact via H. Lundbeck A/S

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: H. Lundbeck A/S

Disqualifiers: Fibromyalgia, Chronic pain, Psychiatric conditions, Cardiovascular disease, others

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: 3

609 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 assist individuals whose migraines are triggered by overusing headache medicines. Eptinezumab already prevents migraines, and researchers seek to discover if it can reduce migraine days and lessen the need for other headache medicines. Participants will receive either eptinezumab (a preventive migraine treatment) or a placebo through an IV at the start and again after 12 weeks. The trial seeks adults who experience migraines on at least eight days a month and have headaches on 15 or more days each month. As a Phase 4 trial, eptinezumab is already FDA-approved and proven effective, and this research helps understand how it benefits more patients.

Do I have to stop taking my current medications for the trial?

The trial summary suggests that participants may need to reduce or stop using acute headache or migraine medications, but it does not specify a clear requirement. It's best to discuss your current medications with the trial team.

What is the safety track record for eptinezumab?

Research has shown that eptinezumab is generally well-tolerated. In studies, many people with migraines used this medication for several years, and it proved to be safe. Common side effects were mild, such as a runny nose or sore throat.

Other studies found that about 42% of people taking eptinezumab experienced these side effects, indicating that some people had no side effects at all. Importantly, serious issues were rare.

The FDA has already approved eptinezumab for preventing migraines, confirming its safety for use. Therefore, those considering joining a trial for this medication can be assured that it has been tested in many people before. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Eptinezumab is unique because it offers a rapid and convenient way to manage migraines through an intravenous (IV) infusion, which is different from the more common oral medications or self-injected treatments currently available. Unlike most migraine treatments that require frequent dosing, eptinezumab is administered just once every 12 weeks, potentially increasing convenience and adherence for patients. Additionally, eptinezumab targets the calcitonin gene-related peptide (CGRP) pathway, a specific mechanism involved in migraine attacks, providing a targeted approach that has shown promise in reducing the frequency and severity of migraines. Researchers are excited about the potential of this treatment to provide fast and long-lasting relief with fewer doses.

What is the effectiveness track record for eptinezumab in treating migraine and medication overuse headache?

Research has shown that eptinezumab can reduce the number of migraine days for migraine sufferers. In one study, about half of the participants experienced a reduction of 50% or more in their monthly migraine days. Another study found that, on average, patients had nine fewer migraine days each month. Additionally, eptinezumab demonstrated positive results in decreasing migraine days and reducing the need for emergency medication in people with medication-overuse headaches. This trial will evaluate eptinezumab's effectiveness, with participants initially receiving either eptinezumab or a placebo, followed by eptinezumab for all participants at Week 12. These findings suggest that eptinezumab could benefit those dealing with both migraines and medication-overuse headaches. ^{6 7 8 9 10}

Who Is on the Research Team?

Email contact via H. Lundbeck A/S

Principal Investigator

[e-mail]

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I was diagnosed with migraines before or at the age of 50.

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

I have been diagnosed with migraine or medication overuse headache.

Exclusion Criteria

I have been diagnosed with a jaw joint disorder.

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

My psychiatric condition has been stable and treated for at least 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Placebo-controlled Treatment

Participants receive either a placebo or eptinezumab infusion at Week 0

12 weeks

1 visit (in-person) at Week 0

Open-label Treatment

All participants receive an eptinezumab infusion at Week 12

12 weeks

1 visit (in-person) at Week 12

Safety Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Eptinezumab

Trial Overview 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.

How Is the Trial Designed?

Group I: Eptinezumab Experimental Treatment 1 Intervention

Participants will receive an intravenous (IV) infusion of eptinezumab at Week 0 and Week 12.

Group II: Placebo Placebo Group 2 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.

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]

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]

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 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]

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]

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 (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]

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40332560/

A 24-week prospective, multicenter, real-world study on ... Conclusions: This real-world study documents that 24-week eptinezumab treatment is rapidly effective and well tolerated in migraine patients ...

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-302553630.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. neurologylive.com neurologylive.com/view/cgrp-inhibitor-eptinezumab-shows-strong-efficacy-treating-medication-overuse-headache

CGRP Inhibitor Eptinezumab Shows Strong Efficacy in ... Eptinezumab significantly reduced monthly migraine days and acute medication use in chronic migraine patients with medication-overuse headache.

5. 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 ...

6. 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.

7. 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 ...

8. 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, ...

9. 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 ...

10. es.aetna.com es.aetna.com/cpb/medical/data/900_999/0970.html

Eptinezumab-jjmr (Vyepti) - Medical Clinical Policy Bulletins The authors concluded that eptinezumab (100 mg or 300 mg) significantly reduced migraine frequency, was well tolerated, and had an acceptable safety profile ...