Eptinezumab for Migraine

Recruiting at 101 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

Trial Summary

What is the purpose of this trial?

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.

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.

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}

What makes the drug Eptinezumab unique for treating migraines?

Eptinezumab is unique because it is administered as an intravenous (IV) infusion every three months, which is different from other migraine treatments that are often taken orally or as injections more frequently. It works by targeting a specific protein involved in migraine development, offering a novel approach compared to traditional migraine medications. ^{6 7 8 9 10}

Research Team

Email contact via H. Lundbeck A/S

Principal Investigator

[e-mail]

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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. 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]

2. England pubmed.ncbi.nlm.nih.gov

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

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

Eptinezumab: First Approval. [2022]

4. 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]

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

A Review of Eptinezumab Use in Migraine. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Treatment of juvenile myoclonic epilepsy. [2021]

8. Japan pubmed.ncbi.nlm.nih.gov

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

9. 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]

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

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