Eptinezumab for Migraine

Not yet recruiting at 1 trial location

Overseen By Julia Joyes Clinical Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Dr George Medvedev

Must not be taking: Anti-CGRP therapy

Disqualifiers: Severe cardiovascular, Renal dysfunction, Pregnant, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called eptinezumab to determine if it prevents migraines from returning after treatment in the Emergency Department (ED). Although eptinezumab is already approved for migraine prevention, researchers are still studying its quick action in the ED setting. The trial will compare results for those receiving standard care alone with those also receiving eptinezumab. Individuals who frequently visit the ED for migraines and meet certain criteria might be suitable candidates. Researchers hope eptinezumab will reduce the need for follow-up visits and improve overall migraine management. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential widespread use of eptinezumab for migraine management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently on anti-CGRP therapy with monoclonal antibodies.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that patients generally tolerate eptinezumab well. One study found that people using eptinezumab experienced fewer migraine days than those taking a placebo, suggesting its effectiveness and safety for many with migraines. Another study examined its long-term use and found it safe even for those who didn’t benefit from other migraine treatments.

Eptinezumab has already received approval in Canada for preventing migraines, indicating its safety for humans. While this study will focus on its short-term use in the emergency department, existing research supports its overall safety and tolerability. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for migraines?

Unlike standard migraine treatments that typically involve oral medications like triptans or over-the-counter pain relievers, eptinezumab is a monoclonal antibody that targets the calcitonin gene-related peptide (CGRP) pathway, which plays a key role in migraine development. This treatment is particularly exciting because it is administered via a single infusion, potentially offering rapid and sustained relief from migraines. Researchers are enthusiastic about eptinezumab because it may provide a more effective and longer-lasting solution for those who suffer from frequent and severe migraines.

What evidence suggests that eptinezumab might be an effective treatment for migraines in the ED?

Research shows that eptinezumab, which participants in this trial may receive alongside standard care, can reduce the number of migraine days. In earlier studies, about half of the patients saw their monthly migraine days cut in half, with some experiencing around nine fewer days each month. Eptinezumab acts quickly and provides long-lasting prevention. It also reduces the need for other migraine medications. While researchers continue to study its immediate effect in emergencies, its ability to quickly stop migraines makes it a promising option for preventing their recurrence. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for patients who come to the Emergency Department with a migraine. It's designed to see if eptinezumab, given during their visit, can prevent future migraines. To join, individuals must have a diagnosis of migraine and be in need of emergency care.

Inclusion Criteria

I am in the ER for a migraine that fits specific medical criteria.

I am between 19 and 75 years old and have a history of migraines.

Provided signed informed consent

Exclusion Criteria

Currently involved in active litigation

Currently enrolled in another investigational drug trial

Pregnant or at risk of becoming pregnant (absent contraception)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single infusion of eptinezumab in the Emergency Department as an adjunct to standard care

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of migraine recurrence and other health measures

3 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Eptinezumab

Trial Overview

The study tests whether eptinezumab (Vyepti), when added to standard ED treatments for migraines, can stop migraines from returning shortly after treatment. The goal is also to see if it reduces return ED visits and improves overall well-being.

How Is the Trial Designed?

Group I: Standard of Care + Eptinezumab Experimental Treatment 2 Interventions

In addition to standard of care, participants randomized to the Standard of Care + Eptinezumab arm will receive a single infusion of eptinezumab (100mg/mL).

Group II: Standard of Care Experimental Treatment 1 Intervention

SoC will be delivered at the discretion of the treating physician

Who Is Running the Clinical Trial?

Dr George Medvedev

Lead Sponsor

Trials

2

Recruited

120+

H. Lundbeck A/S

Industry 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

Centre for Neurology Studies, Surrey Neuroplasticity Clinic Inc.

Collaborator

Trials

1

Recruited

100+

Royal Columbian Hospital

Collaborator

Trials

3

Recruited

2,300+

Surrey Memorial Hospital

Collaborator

Trials

1

Recruited

100+

Royal Columbian Hospital Foundation

Collaborator

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

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]

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 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]

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.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10662788/

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

The long-term effectiveness and safety/tolerability of eptinezumab in patients with migraine and 2–4 prior preventive treatment failures was demonstrated.

7.

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 ...

8.

neurology.org

neurology.org/doi/10.1212/WNL.0000000000009169

Efficacy and safety of eptinezumab in patients with chronic ...

The ≥75% and ≥50% migraine responder rates for the eptinezumab 100 mg and 300 mg dose groups were greater than for placebo. These findings are consistent with ...

9.

jamanetwork.com

jamanetwork.com/journals/jamaneurology/fullarticle/2833817

Efficacy and Safety of Eptinezumab in Episodic Cluster ...

Eptinezumab was generally well tolerated but did not reduce the mean number of weekly cluster headache attacks over weeks 1 to 2 compared with placebo.