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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
Summary
This triallooks at how Botox affects the pain of chronic migraine sufferers, comparing tissues with and without Botox treatment.
Eligible Conditions
- Migraine
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
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 • NCT023214367%
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
2,955 Previous Clinical Trials
13,212,629 Total Patients Enrolled
5 Trials studying Migraine
329 Patients Enrolled for Migraine
Beth Israel Deaconess Medical CenterOTHER
840 Previous Clinical Trials
13,011,670 Total Patients Enrolled
2 Trials studying Migraine
43 Patients Enrolled for Migraine
William G. Austen, MDPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have an infection where the injection is supposed to go.You have had bad reactions to Botox in the past.You must be between 18 and 65 years old.Your neurologist has recommended you for surgery to relieve pressure on nerves outside the skull.You have been diagnosed with chronic migraine based on specific criteria and experience consistent neck muscle tenderness.
Research Study Groups:
This trial has the following groups:- Group 1: Botulinum toxin type A injection arm
Awards:
This trial has 4 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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