Eptinezumab for Pediatric Migraine
(REJOIN Trial)
Recruiting in Palo Alto (17 mi)
+70 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: H. Lundbeck A/S
Disqualifiers: Adverse events, Anaphylactic reaction, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?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.
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.
What data supports the effectiveness of the drug Eptinezumab for pediatric migraine?
Eptinezumab has been shown to reduce the number of migraine days in adults, with significant reductions in both episodic and chronic migraines. While specific data for pediatric use is not provided, its effectiveness in adults suggests potential benefits for children as well.
12345Is eptinezumab safe for use in humans?
Eptinezumab, also known as Vyepti, is generally considered safe for preventing migraines in adults, with common mild side effects like nasal congestion and upper respiratory infections. It has been well tolerated in studies, even in patients with other health conditions like obesity and diabetes, but more research is needed to confirm its long-term safety.
13467How is the drug eptinezumab different from other migraine treatments?
Eptinezumab is unique because it is given as a quarterly infusion (injected directly into the bloodstream) and works quickly to prevent migraines by blocking a protein called CGRP, which is involved in causing migraines. This fast-acting infusion method sets it apart from other migraine treatments that may be taken more frequently or in different forms.
12458Eligibility Criteria
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
+1 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Eptinezumab 300 mgExperimental Treatment1 Intervention
Participants will receive 3 intravenous (IV) infusions of eptinezumab 300 mg (weight adjusted) at Weeks 0, 12, and 24.
Group II: Eptinezumab 100 mgExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Helen DeVos Children HospitalGrand Rapids, MI
Devos Childrens HospitalGrand Rapids, MI
True North NeurologyCommack, NY
Vancouver Island Health AuthorityVictoria, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
H. Lundbeck A/SLead Sponsor
References
Eptinezumab: First Approval. [2022]Eptinezumab-jjmr (referred to as eptinezumab hereafter; Vyepti™) is a humanised monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) and blocks its binding to the receptor. CGRP is believed to play a major role in the pathophysiology of migraine. Eptinezumab, delivered by intravenous (IV) administration, is being developed by Lundbeck Seattle BioPharmaceuticals for the prevention of migraine. In February 2020, eptinezumab was approved in the USA for the preventive treatment of migraine in adults. This article summarizes the milestones in the development of eptinezumab leading to this first approval.
Eptinezumab-jjmr, a humanized monoclonal specific to Calcitonin Gene Related Peptide, for the preventive treatment of migraine in adults. [2022]Migraines are prevalent and cause significant morbidity, decline in quality of life and healthcare costs universally. Treatment options are varied, but efficacy is limited. This review centers on Eptinezumab-jjmr, a humanized monoclonal specific to CGRP for the prevention of migraines in adults. Herein presented are the science and mechanism of action, indication and clinical evidence for use.
Eptinezumab for adolescents with chronic refractory headache: A retrospective chart review. [2023]To evaluate the safety and efficacy of eptinezumab for the treatment of chronic refractory headache in adolescents.
Long-term safety and tolerability of eptinezumab in patients with chronic migraine: a 2-year, open-label, phase 3 trial. [2021]Eptinezumab, an anti-calcitonin gene-related peptide monoclonal antibody recently approved in the United States for preventive treatment of migraine in adults, was found to be well tolerated in double-blind, placebo-controlled studies in patients with episodic and chronic migraine. The objective of the PREVAIL study was to evaluate the long-term safety, immunogenicity, and impact on patient-reported outcomes of repeat doses of eptinezumab in patients with chronic migraine.
Eptinezumab: A calcitonin gene-related peptide monoclonal antibody infusion for migraine prevention. [2021]This article seeks to analyze the clinical trials concerning the newly approved eptinezumab to assess its efficacy, safety, and application to current clinical practice. The Institute of Health US National Library of Medicine Clinical Trials, PubMed, and Cochrane Library databases were searched for relevant abstracts, journal articles, and other published sources. Search terms included eptinezumab, Vyepti®, and ALD403. Relevant English-language articles were evaluated and included in the narrative. Two randomized controlled trials compared quarterly infusions of eptinezumab 100 mg, eptinezumab 300 mg, and placebo in chronic and episodic migraine sufferers. In episodic migraine, eptinezumab resulted in a reduction of approximately 4 monthly migraine days, which was significant compared to placebo. In chronic migraine, eptinezumab reduced monthly migraine days by approximately 8 days, also significant compared to placebo. More patients who received eptinezumab experienced at least 75% reduction in monthly migraine days compared to placebo, resulting in a number needed to treat as low as 6, depending on the study population and the dose. The preventive impact was noticed day one post-infusion. The most common treatment-emergent adverse events were nausea and fatigue, and there was a low incidence of hypersensitivity or study withdrawal. Eptinezumab is the fourth Calcitonin Gene-related Peptide monoclonal antibody to receive Federal Drug Administration approval. Its delivery as a quarterly infusion sets it apart from the other agents in this class. As an infusion, eptinezumab has a quick onset of action that may prove especially beneficial to those with severe or refractory episodic or chronic migraines, despite the perceived increased direct and indirect cost of an infusion.
A Review of Eptinezumab Use in Migraine. [2023]We present a review of the efficacy and safety profile of eptinezumab (also known by the brand name Vyepti), a calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) developed by Lundbeck Seattle BioPharmaceuticals, Inc., that received its first approval in the USA on 21 February 2020 for the preventive treatment of migraine in adults. It is administered by an intravenous infusion at a 100 mg dose every 3 months and shows no drug interactions. Studies have shown that eptinezumab is an effective preventative medication in migraine which starts showing its effect from day 1 of its administration, which maintains a consistent level of efficacy through a year of its treatment at doses 100 mg and 300 mg. It was found to be effective at reducing time to headache pain freedom during acute migraine attacks as well. Eptinezumab is a relatively safe drug for the prevention of migraines with treatment-related adverse events occurring at a low frequency. They bear a safe profile in patients with comorbidities like obesity and type 1 diabetes. The most frequent adverse events observed were nasopharyngitis, upper respiratory tract infections (URTIs), and sinusitis and were usually mild. The development of anti-drug antibodies was common, but they declined to undetectable levels with continued dosing and did not appear to impact the overall safety profile of the drug. Further studies are needed to assess long-term safety, use in different patient populations, and to compare its efficacy to other drugs of its class.
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]The monoclonal antibody eptinezumab, which targets calcitonin gene-related peptide, has shown migraine preventive effects starting the day following infusion and acceptable safety and tolerability in phase 3 trials, but benefits in the subpopulations of patients with previous preventive treatment failures were not examined. We aimed to investigate the safety and efficacy of eptinezumab for migraine prevention in adults with migraine and two-to-four previous preventive treatment failures.
Long-term reductions in disease impact in patients with chronic migraine following preventive treatment with eptinezumab. [2022]Eptinezumab is an anti-calcitonin gene-related peptide humanized monoclonal antibody approved for the preventive treatment of migraine in adults. The PREVAIL study demonstrated a favorable safety profile with sustained reductions in overall migraine-related burden in patients with chronic migraine (CM). This post hoc analysis aimed to examine item-level changes in the Migraine Disability Assessment (MIDAS) questionnaire over 2 years in participants with CM on eptinezumab treatment.