What side effects are associated with this type of intervention?

Common treatments for migraines that involve the inhibition of calcitonin gene-related peptide (CGRP) include monoclonal antibodies like Eptinezumab. These treatments are generally well-tolerated, with no significant difference in the incidence of adverse events compared to placebo. The main side effects reported include upper respiratory tract infections, nausea, and injection site reactions. Other treatments, such as topiramate and sodium valproate, can cause side effects like weight gain, drowsiness, and gastrointestinal issues. Acupuncture, another preventive treatment, is associated with fewer adverse outcomes compared to drug treatments.

What prior FDA approvals exist?

The FDA has approved several treatments for migraine that involve the inhibition of calcitonin gene-related peptide (CGRP). Eptinezumab, an intravenous anti-CGRP monoclonal antibody, is one such treatment. Other similar FDA-approved drugs include fremanezumab, galcanezumab, and erenumab, which are also monoclonal antibodies targeting CGRP or its receptor. These treatments have shown efficacy in reducing the frequency and severity of migraine attacks by blocking the activity of CGRP, a neuropeptide involved in migraine pathophysiology.

What other types of research exist?

Promising alternatives to Eptinezumab for migraine treatment include other CGRP inhibitors such as Erenumab, Galcanezumab, and Fremanezumab. Additionally, non-CGRP options like Topiramate and Verapamil have shown efficacy in migraine prophylaxis. These alternatives offer different mechanisms of action and may provide effective treatment options for patients.

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Monoclonal Antibodies

Eptinezumab for Chronic Migraine in Adolescents (PROSPECT-2 Trial)

Phase 3

Recruiting

Research Sponsored by H. Lundbeck A/S

Eligibility Criteria Checklist

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

Must have

Participant has a diagnosis of migraine (with or without aura) as defined by International Classification of Headache Disorders 3 (ICHD-3) guidelines with history of chronic migraine, of at least 6 months prior to the screening visit

Be younger than 18 years old

Must not have

Participant has a history or diagnosis of complicated migraine, chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, ophthalmoplegic migraine, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration; for example >60 minutes)

Participant has previously been randomized in this study and exposed to eptinezumab

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, Eptinezumab may cause reactions similar to other monoclonal antibodies such as injection site reactions, potential allergic responses, fatigue, or flu-like symptoms.

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2020 Phase 3 trial • 485 Patients • NCT04152083

Hypersensitivity

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Eptinezumab

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: Eptinezumab 300 mgExperimental Treatment1 Intervention

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

Group II: Eptinezumab 100 mgExperimental Treatment1 Intervention

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

Group III: PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Eptinezumab

2021

Completed Phase 3

~2200

0 / 4Eligibility 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 reduce the frequency of attacks. Eptinezumab, like other CGRP inhibitors, targets the calcitonin gene-related peptide, a molecule involved in the transmission of pain and the dilation of blood vessels in the brain, thereby reducing migraine frequency and severity. NSAIDs, such as ibuprofen and naproxen, reduce inflammation and pain by inhibiting cyclooxygenase enzymes. Triptans, another common treatment, activate serotonin receptors to constrict blood vessels and block pain pathways in the brain. Neuromodulation techniques, such as transcutaneous nerve stimulation, alter nerve activity to reduce migraine frequency. Understanding these mechanisms helps patients and doctors choose the most effective treatment based on individual needs and response patterns.

Efficacy and Safety of Monoclonal Antibody Against Calcitonin Gene-Related Peptide or Its Receptor for Migraine: A Systematic Review and Network Meta-analysis.Targeting calcitonin gene-related peptide: a new era in migraine therapy.