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Neurotoxin

Botox for Migraine

Phase 4
Waitlist Available
Led By William G. Austen, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-65 years
Diagnosis of Chronic Migraine consistent with International Classification of Headache Disorders (ICHD-III) criteria, with a history of bilateral headache pain and chronic tenderness in neck muscles
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights

Study Summary

This triallooks at how Botox affects the pain of chronic migraine sufferers, comparing tissues with and without Botox treatment.

Eligible Conditions
  • Migraine

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You must be between 18 and 65 years old.
Select...
You have been diagnosed with chronic migraine based on specific criteria and experience consistent neck muscle tenderness.
Select...
Your neurologist has recommended you for surgery to relieve pressure on nerves outside the skull.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
molecular markers in discarded tissue of migraine patients

Side effects data

From 2016 Phase 4 trial • 42 Patients • NCT02321436
7%
Head injury
7%
Insomnia
4%
Pain
4%
Asthma
4%
Tachycardia
4%
Constipation
4%
Pyrexia
4%
Cough
4%
Hypertensive crisis
4%
Pneumonia
4%
Vomiting
4%
Fall
4%
Hypokalaemia
4%
Urinary tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dysport ® 500 U
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: Botulinum toxin type A injection armExperimental Treatment1 Intervention
All patients will be injected with Botulinum toxin on one side of the back of the head.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Botulinum toxin type A
FDA approved

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,306 Total Patients Enrolled
5 Trials studying Migraine
385 Patients Enrolled for Migraine
Beth Israel Deaconess Medical CenterOTHER
836 Previous Clinical Trials
13,010,287 Total Patients Enrolled
2 Trials studying Migraine
43 Patients Enrolled for Migraine
William G. Austen, MDPrincipal InvestigatorMassachusetts General Hospital

Media Library

Botulinum toxin type A (Neurotoxin) Clinical Trial Eligibility Overview. Trial Name: NCT03381261 — Phase 4
Migraine Research Study Groups: Botulinum toxin type A injection arm
Migraine Clinical Trial 2023: Botulinum toxin type A Highlights & Side Effects. Trial Name: NCT03381261 — Phase 4
Botulinum toxin type A (Neurotoxin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03381261 — Phase 4

Frequently Asked Questions

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

Is there an age criterion for enrollment in this experiment?

"This clinical trial is looking for adult participants aged 18 to 65."

Answered by AI

Is it possible for me to participate in this experiment?

"Qualifying individuals for this research must have a diagnosed migraine and be between the legal age of consent and 65 years old. Approximately 49 participants are needed in order to complete this study."

Answered by AI

To what afflictions is Botulinum toxin type A injection arm typically administered?

"Botulinum toxin type A injection is a common therapeutic intervention for urinary incontinence, along with spinal cord injury, botox injections and overactive bladder syndrome (oabs)."

Answered by AI

Has the FDA endorsed Botulinum toxin type A injection arm?

"As this therapy has already been approved, we can confidently rate the safety of Botulinum toxin type A injection arm as a 3 on our scale."

Answered by AI

To what extent has Botulinum toxin type A injection arm been evaluated in prior clinical trials?

"Currently, there are 59 active medical studies examining Botulinum toxin type A injection arm with 19 trials in the advanced Phase 3. Out of all these locations, Farmington Hills Michigan is home to a few such experiments while 726 other clinical trial sites offer this treatment option."

Answered by AI

Are there currently any open positions for participants in this research?

"According to clinicaltrials.gov, this experiment is no longer seeking participants as its posting dates range from December 1st 2017 to the fifth of December 2022. However, there are currently 234 other trials recruiting patients at present time."

Answered by AI

How extensive is the participation in this clinical experiment?

"As of the most recent update on December 5th 2022, this particular trial is not recruiting. However, if you are interested in participating in a medical study there are 175 trials focused on migraine and 59 studies on Botulinum toxin type A injection currently searching for volunteers."

Answered by AI

Who else is applying?

What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
~7 spots leftby Apr 2025