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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

Study Summary

This trial will assess the effects of BOTOX in preventing migraine in adult participants with EM.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in the Frequency of Monthly Migraine Days
Secondary outcome measures
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

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
~1270

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.

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

AllerganLead Sponsor
781 Previous Clinical Trials
276,054 Total Patients Enrolled
10 Trials studying Migraine
5,869 Patients Enrolled for Migraine
AbbVieLead Sponsor
982 Previous Clinical Trials
507,376 Total Patients Enrolled
11 Trials studying Migraine
8,109 Patients Enrolled for Migraine
ALLERGAN INC.Study DirectorAllergan
75 Previous Clinical Trials
78,744 Total Patients Enrolled
5 Trials studying Migraine
4,687 Patients Enrolled for Migraine

Media Library

BOTOX (Neurotoxin) Clinical Trial Eligibility Overview. Trial Name: NCT05028569 — Phase 3
Migraine Research Study Groups: BOTOX Dose A, BOTOX Dose B, Placebo
Migraine Clinical Trial 2023: BOTOX Highlights & Side Effects. Trial Name: NCT05028569 — Phase 3
BOTOX (Neurotoxin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05028569 — Phase 3
Migraine Patient Testimony for trial: Trial Name: NCT05028569 — Phase 3
~217 spots leftby Jun 2025