What is the mechanism of action of this treatment?

CGRP receptor antagonists, such as Atogepant, work by blocking the calcitonin gene-related peptide (CGRP) receptors, which play a crucial role in mediating pain transmission and neurogenic inflammation associated with migraines. Triptans, another common treatment, activate 5-HT(1B/1D) receptors to constrict blood vessels and inhibit the release of pro-inflammatory neuropeptides, thereby reducing migraine pain. NSAIDs and acetaminophen alleviate migraine symptoms by inhibiting the production of prostaglandins, which are involved in pain and inflammation pathways. Understanding these mechanisms is vital for migraine patients as it helps in selecting the most appropriate treatment based on the specific pathophysiological processes involved in their migraine attacks.

What side effects are associated with this type of intervention?

Common treatments for migraines include CGRP receptor antagonists like Atogepant, triptans, NSAIDs, and anticonvulsants. CGRP receptor antagonists, such as Atogepant, are generally well-tolerated but can cause side effects like nausea, constipation, and fatigue. Triptans, used for acute migraine relief, may cause dizziness, chest tightness, and cardiovascular issues. NSAIDs can lead to gastrointestinal problems, including ulcers and bleeding. Anticonvulsants like topiramate may cause cognitive side effects, weight loss, and paresthesia. Patients should discuss these potential side effects with their healthcare provider to determine the best treatment option.

What prior FDA approvals exist?

The FDA has approved several CGRP receptor antagonists for the treatment of migraine. These include Erenumab (Aimovig), Fremanezumab (Ajovy), and Galcanezumab (Emgality), which are used for the preventive treatment of migraine. These drugs work by blocking the calcitonin gene-related peptide (CGRP) receptor, which is involved in migraine pathophysiology. Atogepant, currently being studied, is another CGRP receptor antagonist aimed at preventing chronic or episodic migraine.

What other types of research exist?

Promising novel alternatives to Atogepant for migraine patients include Ubrogepant, another CGRP receptor antagonist, which has shown efficacy in acute migraine treatment. Additionally, Lasmiditan, a serotonin (5-HT1F) receptor agonist, is approved for acute migraine treatment. For preventive treatment, monoclonal antibodies targeting CGRP, such as Galcanezumab, are also effective options.

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Calcitonin Gene-Related Peptide (CGRP) Antagonist

Atogepant for Migraine Prevention

Phase 3

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

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

Must have

Eligible participants who completed Visit 7, and Visit 8 if applicable, of Study 3101-303-002 or Study 3101-304-002 without significant protocol deviations and who did not experience an Adverse Event that may indicate an unacceptable safety risk.

Be older than 18 years old

Must not have

Participants with hypertension at Visit 1.

Participants requiring any medication, diet, or nonpharmacological treatment on the list of prohibited concomitant medications or treatments that cannot be discontinued or switched to an allowable alternative.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 156 weeks

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing a medication called Atogepant to see if it can safely and effectively prevent migraines in people who have them often. The medication works by blocking signals in the brain that cause migraines. Atogepant is a newly approved oral medication for the prevention of episodic migraine.

Who is the study for?

This trial is for people who have chronic or episodic migraines and were part of earlier studies without major issues or serious side effects. They shouldn't need any off-limits treatments, have significant heart problems, uncontrolled high blood pressure, a risk of self-harm, or other serious health conditions.

What is being tested?

The study tests the long-term safety and tolerability of Atogepant 60 mg taken daily to prevent migraines. It's an extension study for participants from previous trials on this medication.

What are the potential side effects?

While not specified here, common side effects may include digestive discomforts like constipation or nausea, fatigue, dry mouth and potential allergic reactions. Each person might experience different side effects.

Eligibility Criteria

Inclusion Criteria

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

Select...

I completed previous study visits without major issues or unsafe side effects.

Exclusion Criteria

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

Select...

I have high blood pressure.

Select...

I am not on any medication or treatment that cannot be stopped or changed for the trial.

Select...

I have a serious health condition affecting my blood, hormones, heart, lungs, kidneys, liver, stomach, intestines, or nervous system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 156 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~156 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 156 weeks for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation and Behaviour using 5-Point Scales

Side effects data

From 2022 Phase 3 trial • 315 Patients • NCT04740827

10%

CONSTIPATION

COVID-19

NAUSEA

NASOPHARYNGITIS

VENTRICULAR TACHYCARDIA

BREAST CANCER STAGE II

INVASIVE BREAST CARCINOMA

ABORTION INDUCED

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Atogepant 60 mg

Awards & Highlights

Pivotal Trial

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

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Atogepant 60 mgExperimental Treatment1 Intervention

Taken once daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atogepant 60 mg

2021

Completed Phase 3

~1280

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

CGRP receptor antagonists, such as Atogepant, work by blocking the calcitonin gene-related peptide (CGRP) receptors, which play a crucial role in mediating pain transmission and neurogenic inflammation associated with migraines. Triptans, another common treatment, activate 5-HT(1B/1D) receptors to constrict blood vessels and inhibit the release of pro-inflammatory neuropeptides, thereby reducing migraine pain. NSAIDs and acetaminophen alleviate migraine symptoms by inhibiting the production of prostaglandins, which are involved in pain and inflammation pathways. Understanding these mechanisms is vital for migraine patients as it helps in selecting the most appropriate treatment based on the specific pathophysiological processes involved in their migraine attacks.

Prevention of migraine with monoclonal antibodies against CGRP or the CGRP receptor: Addition to the S1 guideline: Therapy of migraine attacks and prevention of migraine. Recommendations of the Germany Society of Neurology and the German Migraine and Headache Society.Calcitonin gene-related peptide receptor antagonists for migraine.