Eptinezumab for Migraine

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

102 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to investigate how a medication called eptinezumab (Vyepti) given to patients in the Emergency Department (ED) might help prevent migraines from happening again. The results of this study may help inform better ways to manage patients with migraines in the ED. Eptinezumab is currently approved by Health Canada for the preventive treatment of migraine, but its short-term effectiveness in the ED context is unknown. Unlike other migraine treatments used in the ED, eptinezumab can rapidly interrupt the migraine process, potentially also preventing migraine from coming back in the short term. Most patients with a diagnosis of migraine have no access to preventative therapies. This study will be able to provide access to preventative therapy at the earliest stages of a migraine attack. Administering this medication in the ED may stop the attack more effectively compared to current therapies. This study wants to see if eptinezumab could help stop migraines from coming back after individuals have been treated in the ED. The study will also explore whether eptinezumab could reduce how often individuals with migraine might need to come back to the ED, what other medications they might need alongside eptinezumab, and how they feel overall.

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 eptinezumab safe for humans?

Eptinezumab, also known as Vyepti, is generally considered safe for humans, with most side effects being mild, such as nasopharyngitis (common cold), upper respiratory infections, and sinusitis. It has been well tolerated in studies, even in people with other health conditions like obesity and type 1 diabetes, and any antibodies against the drug usually disappear with continued use. ^{1 2 3 4 5}

How does the drug Eptinezumab for migraine differ from other treatments?

Eptinezumab is unique because it is administered as an intravenous infusion, which allows for rapid onset of action compared to other migraine treatments that are typically taken orally or as injections. It targets the calcitonin gene-related peptide (CGRP), a protein involved in migraine attacks, providing a novel approach to preventing migraines. ^{6 7 8 9 10}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Eptinezumab: First Approval. [2022]

2. England 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. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

A Review of Eptinezumab Use in Migraine. [2023]

4. England 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. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Eptinezumab: A calcitonin gene-related peptide monoclonal antibody infusion for migraine prevention. [2021]

6. Japan pubmed.ncbi.nlm.nih.gov

Multifocal encephalopathy and autoimmune-mediated limbic encephalitis following tocilizumab therapy. [2019]

7. England 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. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

JAK inhibitors in refractory juvenile idiopathic arthritis-associated uveitis. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Treatment of juvenile myoclonic epilepsy. [2021]

10. England pubmed.ncbi.nlm.nih.gov

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