What side effects are associated with this type of intervention?

Common treatments for migraine, including BOTOX (Botulinum Toxin Type A), can have various side effects. BOTOX injections may cause neck pain, muscle weakness, and injection site pain. Other neuromodulation therapies, such as transcranial magnetic stimulation and vagus nerve stimulation, generally have mild side effects like scalp discomfort and tingling sensations. Preventive medications like topiramate and sodium valproate can cause side effects such as weight loss, cognitive disturbances, and gastrointestinal issues. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for migraine, including Botulinum Toxin Type A (BOTOX), which reduces the frequency and severity of migraine attacks by inhibiting neurotransmitter release. Other approved treatments include neuromodulation devices such as transcranial magnetic stimulation (TMS) and remote electrical neuromodulation, both of which have shown efficacy in reducing migraine pain. Additionally, noninvasive vagus nerve stimulation (nVNS) has been approved for acute migraine treatment. These treatments offer alternatives for patients who do not respond to or cannot take traditional pharmacologic therapies like triptans.

What other types of research exist?

Promising novel alternatives to BOTOX for migraine treatment in 2024 include: 1) CGRP (Calcitonin Gene-Related Peptide) inhibitors such as Erenumab, Fremanezumab, and Galcanezumab, which target the CGRP pathway involved in migraine pathophysiology. 2) Gepants, a new class of oral CGRP receptor antagonists like Rimegepant and Ubrogepant, which provide acute and preventive migraine relief. 3) Ditans, such as Lasmiditan, which are serotonin receptor agonists offering acute migraine treatment with fewer cardiovascular side effects. 4) Non-invasive neuromodulation devices like transcutaneous electrical nerve stimulation (TENS) and single-pulse transcranial magnetic stimulation (sTMS), which modulate neural activity to reduce migraine frequency and severity.

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Neurotoxin

BOTOX Injections for Migraine

Verified Trial

Phase 3

Recruiting

Research Sponsored by Allergan

Eligibility Criteria Checklist

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

Must have

Was the onset of your migraines before the age of 50?

Have you had 6-14 migraine days per month over the last 3 months?

Timeline

Screening 4 weeks

Treatment 52 weeks

Follow Up 0 days

Awards & highlights

Pivotal Trial

Summary

This trial is testing BOTOX injections to prevent migraines in adults who have episodic migraines. BOTOX helps by blocking pain signals in the nerves, reducing migraine frequency and severity. Participants will receive injections and be monitored through periodic medical visits. Botox has been studied for more than a decade as a migraine preventative.

Who is the study for?

Adults who've had 6-14 migraine days per month for the last 3 months, with migraines starting before age 50 and lasting at least a year. They should have tried preventative medications before. Excluded are those with chronic migraine, pregnant or nursing women, and anyone with certain other headache disorders or poor response to more than four previous preventive drugs.

What is being tested?

The trial is testing BOTOX injections as a preventive treatment for adults with episodic migraines compared to placebo. Participants will be randomly assigned into three groups and receive injections on Week 0 and Week 12, then eligible participants again on Week 24 and Week 36.

What are the potential side effects?

While not specified here, common side effects of BOTOX may include pain at the injection site, neck pain, muscle weakness near where the medicine was injected; bruising, bleeding; headache; fever; chills; dizziness.

Eligibility Criteria

Inclusion Criteria

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

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My migraines started before I turned 50.

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I've had 6-14 migraine days monthly for the last 3 months.

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I have had migraines for at least a year.

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I have tried medications to prevent migraines before.

Timeline

Screening ~ 4 weeks1 visit

Treatment ~ 52 weeks14 visits

Follow Up ~ 0 days0 visits

Screening ~ 4 weeks

Treatment ~ 52 weeks

Follow Up ~0 days

This trial's timeline: 4 weeks for screening, 52 weeks for treatment, and 0 days 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 the Frequency of Monthly Migraine Days

Secondary study objectives

Change From Baseline in Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1) Role Function - Restrictive (RFR) Domain Score

Change From Baseline in the Activity Impairment in Migraine - Diary (AIM-D) Physical Impairment Domain Score

Change From Baseline in the Frequency of Monthly Acute Headache Medication Days

+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: BOTOX Dose BExperimental Treatment1 Intervention

Participants will receive BOTOX Dose B on Week 0 and Week 12. Eligible participants will receive BOTOX Dose A on Week 24 and Week 36.

Group II: BOTOX Dose AExperimental Treatment1 Intervention

Participants will receive BOTOX Dose A on Week 0 and Week 12. Eligible participants will receive BOTOX Dose A on Week 24 and Week 36.

Group III: PlaceboPlacebo Group2 Interventions

Participants will receive placebo on Week 0 and Week 12. Eligible participants will receive BOTOX Dose A on Week 24 and Week 36.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BOTOX

2013

Completed Phase 4

~1410

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

Botulinum Toxin Type A (BOTOX) works by inhibiting the release of neurotransmitters involved in pain signaling, such as calcitonin gene-related peptide (CGRP), thereby reducing the frequency and severity of migraine attacks. This mechanism is crucial for migraine patients as it offers a preventive approach, potentially decreasing the number of migraine days and improving quality of life. Similar treatments, like CGRP antagonists, also target this pathway by blocking the effects of CGRP to prevent migraine onset. Understanding these mechanisms aids in selecting appropriate therapies and managing treatment expectations.

Cochrane systematic review and meta-analysis of botulinum toxin for the prevention of migraine.[Botulinum toxin type A in headache treatment : Established and experimental indications].The use of botulinum toxin in the treatment of headaches.