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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 6 months
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
Select...
My migraines started before I turned 50.
Select...
I've had 6-14 migraine days monthly for the last 3 months.
Select...
I have had migraines for at least a year.
Select...
I have tried medications to prevent migraines before.

Timeline

Screening ~ 4 weeks
Treatment ~ 52 weeks
Follow Up ~6 months
This trial's timeline: 4 weeks for screening, 52 weeks for treatment, and 6 months 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
~1200

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
275,792 Total Patients Enrolled
10 Trials studying Migraine
5,869 Patients Enrolled for Migraine
AbbVieLead Sponsor
962 Previous Clinical Trials
502,394 Total Patients Enrolled
10 Trials studying Migraine
7,659 Patients Enrolled for Migraine
ALLERGAN INC.Study DirectorAllergan
75 Previous Clinical Trials
78,482 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Yes, can you tell us about some of the other scientific research that has been conducted using BOTOX?

"BOTOX was first researched in 2012 by the Rothman Institute. Since that time, there have been a total of 18623 completed clinical trials. 69 clinical trials are ongoing, with a large majority of these based in Oklahoma City, Oklahoma."

Answered by AI

Could I possibly be approved to enroll in this experiment?

"777 patients that fit the following description are eligible for this study: Between the ages of 18-65, currently have episodic migraines, 6-14 migraine/probable migraine days during the 4-week screening/baseline phase, less than 15 headache days/month in each of the 3 months prior to Visit 1 and during the 4-week screening/baseline phase, a history of migraine headache disorder meeting International Classification of Headache Disorders (ICHD)-3 diagnostic criteria for migraine with aura or migraine without aura for >= 12 months, onset of migraine before 50 years of age, and a history of 6 to 14 migraine"

Answered by AI

Are there any short or long term risks associated with BOTOX treatments?

"BOTOX safety is estimated to be a 3. This is based on the fact that it is a Phase 3 trial, meaning that there is evidence from multiple rounds of testing that support its efficacy and safety."

Answered by AI

Are there many sites in operation for this research project in Canada?

"This clinical trial has 100 available spots at various locations, some of which include Cutting Edge Research Group /ID# 231095 in Oklahoma City, Artemis Institute for Clinical Research - San Diego /ID# 231103 in San Diego, and Minneapolis Clinic of Neurology in Burnsville."

Answered by AI

For what reason is BOTOX most commonly administered?

"BOTOX is an effective treatment for urinary incontinence, spinal cord compression, and chronic migraines."

Answered by AI

Does this research project allow patients who are senior citizens to enroll?

"This particular trial is only open to patients that are 18-65 years old. There are 38 other trials that cater to a younger demographic and 177 trials for seniors."

Answered by AI

Are people still being recruited for participation in this research?

"Yes, according to the latest update on clinicaltrials.gov, this study is still recruiting patients. This clinical trial was originally posted on 2021-11-05 and was last edited on 2022-11-01. They are looking for 777 patients between 100 sites."

Answered by AI

Who else is applying?

What state do they live in?
California
North Carolina
Iowa
Other
How old are they?
18 - 65
What site did they apply to?
M3 Wake Research Inc. /ID# 232285
Accellacare /ID# 231496
Neurology - Triad /ID# 231733
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
1
3+
0

Why did patients apply to this trial?

Nothing works for my migraines. I’ve had 14 migraines in three months. Hoping trial drugs help with migraines.
PatientReceived no prior treatments
I have never tried Botox for my migraines. I’ve tried multiple medications with no relief.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

When can I start? When will I hear anything back? How long is the screening process?
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Accellacare /ID# 231496: < 24 hours
  2. Neurology - Triad /ID# 231733: < 24 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Study of BOTOX Injections in Prevention of Migraine in Adult Participants With Episodic Migraine
2021. "Study of BOTOX Injections in Prevention of Migraine in Adult Participants With Episodic Migraine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05028569.
All > Migraine Headaches > Migraine
~227 spots leftby May 2025
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