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 (ATO-BOTOX Trial)

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

Must not have

Use of opioid-containing products for more than 4 days per month for acute treatment of headache in the 3 months prior to Screening or during the screening/baseline period

Treatment of study target muscles using acupuncture, transcutaneous electrical nerve stimulation (TENS), cranial traction, dental splints for headache, or head and/or neck injections of anesthetics/steroids within 4 weeks prior to Screening and throughout the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 28 weeks

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new daily pill called atogepant, used along with regular BOTOX treatments, to help prevent migraines. It targets adults who suffer from frequent and severe headaches. The pill works by blocking certain brain signals that trigger migraines. The study will monitor safety, side effects, and effectiveness over several months. Atogepant is a newly approved medication for the prevention of migraine.

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.

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.

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

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I have had chronic migraines for at least a year.

Exclusion Criteria

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

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I've used opioids for headaches more than 4 days a month recently.

Select...

I haven't had treatments like acupuncture or TENS on my head/neck muscles in the last 4 weeks.

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I am not using migraine prevention treatments other than BOTOX or low-dose topiramate.

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

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

Primary study objectives

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 study objectives

Change From Baseline in Mean Monthly Migraine Days

Side effects data

From 2023 Phase 4 trial • 263 Patients • NCT05264129

COVID-19

DECREASED APPETITE

NAUSEA

FATIGUE

CONSTIPATION

100%

80%

60%

40%

20%

Study treatment Arm

Atogepant 60 mg (Period 1)

Atogepant 60 mg + Ubrogepant 100 mg (Period 2)

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

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

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 / 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

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.