Eptinezumab for Pediatric Migraine

(REJOIN Trial)

Recruiting at 96 trial locations

Overseen By Email contact via H. Lundbeck A/S

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: H. Lundbeck A/S

Disqualifiers: Adverse events, Anaphylactic reaction, 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: 3

Duration: 24 weeks

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests eptinezumab, a treatment aimed at reducing migraines in children and teens aged 6 to 17. The goal is to assess its long-term safety for both chronic (frequent) and episodic (less frequent) migraines. Participants will receive one of two different doses of eptinezumab through an intravenous infusion, administered at three different times. The trial seeks children who have previously participated in a migraine study and completed it without major safety issues. As a Phase 3 trial, this represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking migraine treatment for young people.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

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

Research has shown that eptinezumab is generally safe for children and teenagers, with no new safety issues compared to adults. In one study, both children and teenagers experienced fewer migraines after taking eptinezumab. Another small study suggested that eptinezumab might be safe and effective for treating chronic headaches in teens. These findings indicate that eptinezumab has a good safety record for younger patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for pediatric migraine involve oral medications that need frequent dosing, like triptans or preventive medications such as beta-blockers. However, eptinezumab is unique because it is an intravenous infusion that targets the calcitonin gene-related peptide (CGRP), a protein involved in migraine attacks. Researchers are excited about eptinezumab because it offers two dosage options, 300 mg and 100 mg, administered every 12 weeks, potentially providing a longer-lasting effect with fewer treatments. This approach could offer more convenience and possibly faster relief compared to current options, which often require daily administration.

What evidence suggests that eptinezumab might be an effective treatment for pediatric migraine?

This trial will compare two dosages of eptinezumab for pediatric migraine. Research has shown that eptinezumab helps reduce migraine frequency. In one study, 40% of patients who took 300 mg of eptinezumab experienced no migraines for a month or longer. Another study found that eptinezumab significantly reduced the number of migraine days each month. This treatment proves effective even for those who have not responded to other migraine medications. Eptinezumab remains effective and safe for long-term use in individuals with migraines. ^{2 3 4 6 7}

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 children and adolescents aged 6 to 17 who suffer from chronic or episodic migraine and have completed a previous related study. They cannot join if they had severe reactions to the earlier treatment, significant liver test abnormalities, or other safety concerns as determined by the investigator.

Inclusion Criteria

The participant must have completed Week12 (completion) visit of either Study19356A (CM) or Study19357A (EM) immediately prior to enrolment into this OLE study.

Exclusion Criteria

I experienced side effects from a previous study's treatment that may be risky.

During lead-in Study19356A or Study19357A: the participant had a serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value >5 times the upper limit of the reference range that was confirmed by testing <2 weeks later

During lead-in Study19356A or Study19357A: participant experienced an anaphylactic reaction or another severe and/or serious hypersensitivity reaction to the investigational medicinal product (IMP) infusion, as assessed by the investigator

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous infusions of eptinezumab at Weeks 0, 12, and 24

24 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants continue receiving eptinezumab in an open-label format to assess long-term safety

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Eptinezumab

Trial Overview The focus of this study is on evaluating the long-term safety of a medication called Eptinezumab in young patients with migraines. It's an extension of prior studies where participants continue their treatment.

How Is the Trial Designed?

Group I: Eptinezumab 300 mg Experimental Treatment 1 Intervention

Participants will receive 3 intravenous (IV) infusions of eptinezumab 300 mg (weight adjusted) at Weeks 0, 12, and 24.

Group II: Eptinezumab 100 mg Experimental Treatment 1 Intervention

Participants will receive 3 IV infusions of eptinezumab 100 mg (weight adjusted) at Weeks 0, 12, and 24.

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

Eptinezumab-jjmr is a humanized monoclonal antibody targeting CGRP, showing significant efficacy in preventing migraines, which are a prevalent and debilitating condition affecting many adults.

Traditional migraine treatments often have poor adherence and limited effectiveness, highlighting the need for new therapies like Eptinezumab, which aims to fill these gaps in migraine management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eptinezumab-jjmr, a humanized monoclonal specific to Calcitonin Gene Related Peptide, for the preventive treatment of migraine in adults. Berger, AA., Keefe, J., Stark, CW., et al.[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, 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, an anti-CGRP monoclonal antibody, demonstrated significant long-term efficacy in reducing migraine-related disability, with mean MIDAS headache days decreasing from 47.4 at baseline to 16.3 after 104 weeks of treatment.

Patients experienced sustained reductions in both headache frequency and pain severity, with notable improvements in absenteeism and presenteeism, indicating that eptinezumab effectively enhances the quality of life for individuals with chronic migraine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term reductions in disease impact in patients with chronic migraine following preventive treatment with eptinezumab. Blumenfeld, A., Ettrup, A., Hirman, J., 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]

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 (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]

Citations

1. vyeptihcp.com vyeptihcp.com/efficacy-and-patient-outcomes

Efficacy & Patient Outcomes | VYEPTI® (eptinezumab-jjmr) During a 6-month period chronic migraine pivotal trial, 40% of patients treated with VYEPTI 300 mg were 100% migraine free for a month or more vs 22% with ...

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® ... In the RESOLUTION trial (n = 608), eptinezumab met the both the primary and secondary endpoints, showing significantly greater monthly migraine ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05897320

NCT05897320 | A Study of Eptinezumab in Pediatric ... The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.

4. 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.

5. 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.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40444655/

Pharmacokinetics and safety of eptinezumab in children ... Improvement in migraine-associated disability was seen in both children and adolescents after a single intravenous administration of eptinezumab ...

7. 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.