What side effects are associated with this type of intervention?

Common treatments for migraines, particularly CGRP receptor antagonists like Erenumab, often have side effects that include injection site reactions, constipation, and muscle cramps or spasms. Other treatments for migraines, such as triptans, can cause dizziness, fatigue, dry mouth, and in some cases, cardiovascular issues like chest pain or tightness. Ergots, another class of migraine treatments, can lead to nausea, vomiting, and more severe vascular complications, especially with overuse. Preventive medications like valproate can cause weight gain, hair loss, and are contraindicated in pregnancy due to teratogenic effects.

What prior FDA approvals exist?

Erenumab (Aimovig) is a CGRP receptor antagonist that has been approved by the FDA for the preventive treatment of migraines. Other similar FDA-approved treatments include Galcanezumab (Emgality) and Fremanezumab (Ajovy), which are also monoclonal antibodies targeting the CGRP pathway. These drugs have demonstrated efficacy in reducing the number of migraine days per month in clinical trials and are generally well-tolerated with mild adverse effects. Additionally, Eptinezumab (Vyepti) is another CGRP ligand-binding monoclonal antibody approved for migraine prevention, administered via intravenous infusion.

What other types of research exist?

Promising alternatives to Erenumab for migraine treatment in 2024 include: 1) Galcanezumab, another CGRP monoclonal antibody, which has shown efficacy in reducing migraine days in clinical trials. 2) Eptinezumab, a CGRP ligand-binding monoclonal antibody, administered intravenously, which has demonstrated significant reduction in migraine days. 3) Lasmiditan, a serotonin (5-HT1F) receptor agonist, effective for acute migraine treatment. 4) Ubrogepant and Rimegepant, oral CGRP receptor antagonists, effective for acute migraine relief. 5) Non-pharmacological options like neuromodulation devices (e.g., transcutaneous supraorbital neurostimulation) and acupuncture, which have shown benefits in migraine management.

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Monoclonal Antibodies

Erenumab for Migraine (OASIS(CM) Trial)

Verified Trial

Phase 3

Waitlist Available

Research Sponsored by Amgen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Children (6 to less than 12 years of age) or adolescent (12 to less than 18 years of age) at the time of signing, if developmentally appropriate, the formal assent to participate to the study

Subject's parent or legal representative has provided written informed consent before initiation of any study-specific activities/procedures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 83

Awards & highlights

Pivotal Trial

Summary

This trial tests if erenumab, an injection given regularly, can reduce migraine days in children and adolescents with chronic migraines by blocking a protein that triggers these headaches. Erenumab has been shown to reduce migraine days and improve quality of life in adults with chronic and episodic migraines.

Who is the study for?

This trial is for children (6-11 years) and adolescents (12-17 years) with chronic migraine. Participants must have shown good compliance with an eDiary during the baseline period. They can't join if they have major psychiatric disorders, certain types of migraines like cluster or hemiplegic, continuous pain without breaks, a history of suicidal behavior, or no response to more than three previous migraine prevention medications.

What is being tested?

The study tests the effectiveness and safety of different doses of Erenumab against a placebo in preventing migraines in young patients. It aims to see if Erenumab reduces monthly migraine days over a 3-month period compared to those taking a non-active treatment.

What are the potential side effects?

While not specified here, common side effects from similar trials may include injection site reactions such as pain or swelling, constipation, muscle cramps or spasms, and possibly allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a child or teenager who can agree to join the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 83

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 83

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 83 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in MMDs

Secondary study objectives

Change from baseline in migraine-related disability and productivity as assessed by the Pediatric Migraine Disability Assessment (PedMIDAS)

Change in MMDs from baseline to the average of the first 3 months

Change in monthly average severity of migraine attacks from baseline (measured with a visual analogue scale)

+3 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Dose Level 2Experimental Treatment2 Interventions

Participants will be randomized to one of two doses determined by their body-weight at Day 1. Participants who enrolled under the original protocol or protocol amendment 1 will be identified as group 1. Those enrolled under protocol amendment 2 will be identified as group 2.

Group II: Dose Level 1Experimental Treatment2 Interventions

Participants will be randomized to one of two doses determined by their body weight at Day 1. Participants who enrolled under the original protocol or protocol amendment 1 will be identified as group 1. Those enrolled under protocol amendment 2 will be identified as group 2.

Group III: PlaceboPlacebo Group1 Intervention

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Migraine treatments work through various mechanisms to alleviate symptoms and prevent recurrence. Erenumab, a CGRP receptor antagonist, blocks the activity of CGRP, a molecule involved in migraine pathophysiology, thereby reducing the frequency and severity of migraine attacks. Triptans, another common treatment, activate serotonin receptors to constrict blood vessels and inhibit pain pathways. Over-the-counter analgesics like acetaminophen and NSAIDs reduce inflammation and pain. Understanding these mechanisms helps patients and doctors choose the most effective treatment based on individual needs and medical history, improving overall migraine management.

Efficacy of calcitonin gene-related peptide (CGRP) receptor blockers in reducing the number of monthly migraine headache days (MHDs): A network meta-analysis of randomized controlled trials.