What side effects are associated with this type of intervention?

Common treatments for migraine prevention include anticonvulsants like sodium valproate and topiramate, as well as newer medications like atogepant. Sodium valproate can cause side effects such as weight gain, tremor, and hair loss. Topiramate may lead to cognitive side effects, weight loss, and paresthesia. Atogepant, an investigational drug, is being studied for its safety and tolerability, with potential side effects including nausea, constipation, and fatigue. These treatments aim to reduce the frequency and severity of migraine attacks but come with varying side effect profiles that should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for migraine, both for acute relief and prevention. For acute treatment, triptans such as sumatriptan and zolmitriptan are commonly used and have been extensively studied. Preventive treatments include monoclonal antibodies like eptinezumab, which has shown efficacy in reducing the frequency of migraine attacks. Additionally, onabotulinumtoxinA (Botox) is approved for chronic migraine prevention. Atogepant, an investigational drug, is being studied for its potential to prevent chronic migraines, adding to the growing list of preventive options.

What other types of research exist?

Promising novel alternatives to Atogepant for migraine prevention include: <ol> <li>Eptinezumab: An intravenous CGRP monoclonal antibody shown to be effective in reducing migraine days.</li> <li></li> </ol> Galcanezumab: Another CGRP monoclonal antibody effective for patients with chronic and episodic migraines. 3. Erenumab: A CGRP receptor antagonist that has shown efficacy in patients with prior preventive treatment failures. 4. Lasmiditan: An oral medication for acute migraine treatment that may also have preventive benefits. 5. Non-invasive neuromodulation devices: Such as transcranial magnetic stimulation (TMS) and external trigeminal neurostimulation (eTNS), which have shown promise in clinical trials.

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Atogepant + Botox for Chronic Migraine

Phase 3

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

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

Must have

At least a 1-year history of chronic migraine (CM), with or without aura, consistent with a diagnosis according to International Classification of Headache Disorders 3rd edition (ICHD-3 2018) and with or without acute medication overuse as defined in the protocol

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 28 weeks

Awards & highlights

Study Summary

This trial will assess if atogepant is a safe and effective drug to prevent chronic migraine when taken with Botox.

Who is the study for?

Adults with chronic migraine who've been treated with BOTOX for at least two cycles in the past 8 months and have had 8-23 migraine days during a screening period. Participants must not have used certain migraine medications recently, including CGRP pathway blockers or oral gepants, and should not be on other preventive treatments besides BOTOX.Check my eligibility

What is being tested?

The trial is testing the safety and effectiveness of an investigational drug called Atogepant when added to standard BOTOX treatment for preventing migraines. Around 125 participants will take Atogepant daily for 24 weeks while continuing their regular BOTOX injections.See study design

What are the potential side effects?

Possible side effects from adding Atogepant to BOTOX may include reactions typical of migraine prevention medications such as nausea, fatigue, dry mouth, or digestive issues. The study will closely monitor any adverse events throughout its duration.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have had chronic migraines for at least a year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 28 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 28 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 28 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change From Baseline in Monthly Migraine Days

Change from Baseline in Monthly Activity Impairment in Migraine - Diary (AIM-D)

Change from Baseline in Monthly Headache Days, Moderate or Severe Headache Days, Cumulative Hours of Headache, Acute Treatment Medication Use Days, Headache Free Days, and Migraine Symptom-Free Days

+7 more

Other outcome measures

Change From Baseline in Mean Monthly Migraine Days

Side effects data

From 2020 Phase 3 trial • 744 Patients • NCT03700320

10%

Upper respiratory tract infection

Constipation

Nausea

Urinary tract infection

Nasopharyngitis

Fatigue

Dizziness

Anxiety

Paraesthesia

Weight increased

100%

80%

60%

40%

20%

Study treatment Arm

Atogepant 60 mg

Oral SOC Migraine Preventive Medication

Trial Design

1Treatment groups

Experimental Treatment

Group I: AtogepantExperimental Treatment1 Intervention

Participants will receive atogepant once a day (QD) during the 24-week treatment period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atogepant

2018

Completed Phase 4

~3490

0 / 1Eligibility 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

Common treatments for migraine include triptans, CGRP antagonists, and preventive medications like topiramate. Triptans work by stimulating serotonin receptors, leading to the constriction of blood vessels and reduction of inflammation. CGRP antagonists, such as Atogepant, block the calcitonin gene-related peptide (CGRP) receptor, which is involved in the transmission of pain and the dilation of blood vessels during a migraine attack. Preventive medications like topiramate modulate neurotransmitter activity to reduce the frequency and severity of migraines. Understanding these mechanisms helps patients and doctors choose the most effective treatment based on the specific pathophysiology of their migraines, potentially leading to better management and improved quality of life.

Migraine: integrated approaches to clinical management and emerging treatments.Update on the Pharmacological Treatment of Chronic Migraine.Acute and preventive treatment of migraine.