Eptinezumab for Chronic Migraine in Adolescents

(PROSPECT-2 Trial)

Recruiting at 121 trial locations

Overseen By Email contact via H. Lundbeck A/S

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: H. Lundbeck A/S

Must not be taking: Monoclonal antibodies, CGRP antibodies

Disqualifiers: Complicated migraine, Cluster headache, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

285 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether eptinezumab, a monoclonal antibody, can reduce migraine days in young people with chronic migraines. Participants will receive either eptinezumab or a placebo (a harmless saline solution) through an IV. Adolescents aged 12 to 17 who have experienced chronic migraines for at least six months and have frequent headaches, with at least eight migraines each month, are eligible. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking migraine treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have been exposed to certain migraine treatments like monoclonal antibodies or CGRP antibodies in the last 6 months, you may not be eligible to participate.

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

Research has shown that eptinezumab is generally safe and well-tolerated. In a study involving 2,076 people with migraines, many handled the treatment without serious issues. Common side effects included a stuffy nose and fatigue. Another study with adults found that eptinezumab is safe, with few severe side effects reported. Although the FDA has approved the treatment for adults, limited information exists for children and teens. This trial aims to provide more details about its safety for younger individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about eptinezumab for treating chronic migraine in adolescents because it offers a novel approach compared to standard treatments like oral medications and other injectable options. Unlike many current treatments that require frequent dosing, eptinezumab is administered as a single intravenous infusion, potentially offering longer-lasting relief. Additionally, it targets the calcitonin gene-related peptide (CGRP) pathway, which plays a crucial role in migraine pathophysiology, providing a more precise mechanism of action. These features could translate to more effective and convenient migraine management for young patients.

What evidence suggests that eptinezumab might be an effective treatment for chronic migraine in adolescents?

Research has shown that eptinezumab can reduce the number of migraine days for people with chronic migraines. In this trial, participants will receive either eptinezumab at doses of 300 mg or 100 mg, or a placebo, which contains no active medicine. One study found that people taking eptinezumab experienced fewer migraine days than those who received a placebo. Some reports also suggest it works well even for difficult-to-treat migraines. Previous studies with teenagers have indicated that eptinezumab is safe and effective for treating chronic headaches. Overall, the drug has shown promising results in reducing the frequency of migraines and the need for medication to treat sudden migraine attacks. ^{2 6 7 8 9}

Who Is on the Research Team?

Email contact via H. Lundbeck A/S

Principal Investigator

H. Lundbeck A/S

Are You a Good Fit for This Trial?

This trial is for adolescents aged 12-17 with chronic migraine, as defined by ICHD-3 guidelines. They must have had a history of migraines for at least 6 months and experienced ≥15 to ≤26 headache days during the screening period, with at least 8 being migraine days. Participants should not have used any monoclonal antibody or CGRP antibody treatments in the past 6 months.

Inclusion Criteria

I have been diagnosed with chronic migraine for at least 6 months.

During the 28-day screening period, participant must adequately complete the headache eDiary on at least 23 of the 28 days following the screening visit

I've had 15 to 26 headache days, with at least 8 being migraines, in the last 28 days.

Exclusion Criteria

I have a history of severe or unusual types of headaches.

I have been part of this study before and received eptinezumab.

I haven't had any monoclonal antibody treatment in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive a single IV infusion of eptinezumab or placebo during the double-blind, placebo-controlled period

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Eptinezumab
• Placebo

Trial Overview The study aims to determine if Eptinezumab is more effective than a placebo (normal saline solution) in reducing the number of migraine days in young people with chronic migraines. It's a comparison between an active drug and an inactive substance.

How Is the Trial Designed?

Group I: Eptinezumab 300 mg Experimental Treatment 1 Intervention

Participants will receive a single IV infusion of eptinezumab 300 mg (weight adjusted).

Group II: Eptinezumab 100 mg Experimental Treatment 1 Intervention

Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted).

Group III: Placebo Placebo Group 1 Intervention

Participants will receive a single IV infusion of placebo matching to eptinezumab.

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

In the DELIVER clinical trial involving adults with a history of treatment failures, eptinezumab significantly reduced migraine frequency and improved overall patient-reported outcomes compared to placebo, starting as early as week 4.

Patients receiving eptinezumab reported greater improvements in health-related quality of life and specific migraine-related symptoms, with over twice as many patients indicating substantial improvement compared to those on placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eptinezumab improved patient-reported outcomes and quality of life in patients with migraine and prior preventive treatment failures. Goadsby, PJ., Barbanti, P., Lambru, G., et al.[2023]

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, 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 monthly migraine days in patients with difficult-to-treat migraines, with response rates increasing from 65.9% to 70.4% for ≥30% reduction after 12 weeks for the 100 mg dose, and from 71.0% to 74.5% for the 300 mg dose, compared to placebo which showed much lower rates.

Notably, over one-third of patients who initially did not respond to eptinezumab (<30% reduction) experienced a response (≥30% reduction) after their second infusion, indicating potential for improved outcomes with continued treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responder rates with eptinezumab over 24 weeks in patients with prior preventive migraine treatment failures: post hoc analysis of the DELIVER randomized clinical trial. Ashina, M., Lipton, RB., Ailani, J., et al.[2023]

In a small study of 11 adolescents with chronic refractory headaches, eptinezumab (100 mg) showed promising results, with some patients experiencing complete cessation of daily headaches and reductions in headache intensity after the first infusion.

Eptinezumab was well tolerated among participants, and subsequent higher doses (300 mg) led to further improvements in headache frequency and intensity, suggesting its potential as a safe treatment option for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eptinezumab for adolescents with chronic refractory headache: A retrospective chart review. Zorrilla, N., Gelfand, AA., Irwin, SL.[2023]

Eptinezumab was found to be safe and effective for preventing migraines in patients who had previously failed two to four other preventive treatments, as demonstrated in a phase 3b trial.

The study utilized a multi-arm, randomized, double-blind, placebo-controlled design, ensuring robust results that support eptinezumab as a viable option for patients with chronic migraine issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In migraine with previous treatment failures, eptinezumab safely reduced migraine days at 1 to 12 wk. Absher, JR.[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 significantly reduced the number of monthly migraine days in patients aged 50 and older with episodic and chronic migraines, with reductions of up to -4.4 days for episodic migraine and -8.6 days for chronic migraine compared to placebo.

The treatment was well-tolerated, with a similar incidence of mild to moderate adverse events across all groups, indicating that eptinezumab is a safe option for older patients suffering from migraines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eptinezumab for migraine prevention in patients 50 years or older. Martin, V., Tassorelli, C., Ettrup, A., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36633118/

Eptinezumab for adolescents with chronic refractory ... While this was a small sample, findings suggest that eptinezumab may be a safe and effective treatment for chronic, refractory headache in adolescents.

2. prnewswire.com prnewswire.com/news-releases/new-data-demonstrates-robust-efficacy-of-vyepti-eptinezumab-in-otherwise-difficult-to-treat-patients-with-severe-migraine-302487652.html

New data demonstrates robust efficacy of Vyepti® ... The trial was a randomized, placebo-controlled trial designed to evaluate the efficacy of eptinezumab versus placebo in patients with chronic migraine.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05164172

NCT05164172 | A Study With Eptinezumab in Children and ... The main goal of the study is to assess the long-term safety of eptinezumab on children and adolescents ages 6 to 17 with chronic or episodic migraine.

4. headachejournal.onlinelibrary.wiley.com headachejournal.onlinelibrary.wiley.com/doi/10.1111/head.14959

Pharmacokinetics and safety of eptinezumab in children and ... The primary objective was to characterize the pharmacokinetics (PK) and safety of eptinezumab in children and adolescents with migraine.

5. 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.

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8008612/

Safety and tolerability of eptinezumab in patients with ... In adults with migraine, the intravenous administration of eptinezumab every 12 weeks demonstrated a favorable safety and tolerability profile.

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

Vyepti, eptinezumab - European Medicines Agency Paediatric population The safety and efficacy of VYEPTI in children aged 6 to 18 years has not yet been established. Currently no data are available. There is ...

9. aetna.com 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 ...