Eptinezumab for Chronic Migraine in Adolescents

(PROSPECT-2 Trial)

Recruiting in Palo Alto (17 mi)

+85 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: H. Lundbeck A/S

Must not be taking: Monoclonal antibodies, CGRP antibodies

Disqualifiers: Complicated migraine, Cluster headache, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing if eptinezumab, given through an IV, can reduce migraine days in young people aged 12 to 17 who have chronic migraines. Eptinezumab works by blocking a protein that causes migraines. Participants will receive different amounts of the treatment to compare the effects. Eptinezumab has been shown to be effective and safe for preventing migraines in adults.

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.

What data supports the effectiveness of the drug Eptinezumab for treating chronic migraine in adolescents?

Eptinezumab has been shown to reduce migraine frequency and improve quality of life in adults with chronic migraine, even in those who had not responded to other treatments. It works by blocking a protein called CGRP, which is involved in causing migraines. ^{1 2 3 4 5}

Is eptinezumab safe for use in humans?

Eptinezumab has been evaluated for safety in various studies, including in older adults and adolescents with chronic headaches. It has been approved in the USA for preventing migraines in adults, indicating it is generally considered safe for human use. ^{1 2 4 5 6}

How is the drug Eptinezumab unique for treating chronic migraine in adolescents?

Eptinezumab is unique because it is a monoclonal antibody that targets and blocks the calcitonin gene-related peptide (CGRP), which plays a key role in migraines. Unlike other treatments, it is administered as a quarterly infusion, providing a quick onset of action that can be especially beneficial for severe or hard-to-treat migraines. ^{1 4 5 7 8}

Research Team

Email contact via H. Lundbeck A/S

Principal Investigator

H. Lundbeck A/S

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Eptinezumab (Monoclonal Antibodies)
• Placebo (Other)

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.

Participant Groups

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Corewell Health Grand Rapids, MI

Children's Specialty Group - 850 Southampton Ave Norfolk, VA

Michigan State University - Department of Neurology East Lansing, MI

The Kids Clinic Ajax, Canada

More Trial Locations

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

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 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]

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]

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, 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]

References

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

Eptinezumab for adolescents with chronic refractory headache: A retrospective chart review. [2023]

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

Eptinezumab improved patient-reported outcomes and quality of life in patients with migraine and prior preventive treatment failures. [2023]

3. England 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. [2023]

4. Denmark pubmed.ncbi.nlm.nih.gov

Eptinezumab for migraine prevention in patients 50 years or older. [2022]

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

Eptinezumab: First Approval. [2022]

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

In migraine with previous treatment failures, eptinezumab safely reduced migraine days at 1 to 12 wk. [2022]

7. 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]

8. England pubmed.ncbi.nlm.nih.gov

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