← Back to Search

Botulinum toxin type A

Dysport for Migraine Prevention (E-BEOND Trial)

Phase 3
Recruiting
Research Sponsored by Ipsen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must be ≥18 years of age inclusive, at the time of signing the informed consent and privacy/data protection documentation.
Participant has a diagnosis for more than 12 months, prior to screening visit, of migraine with aura or migraine without aura according to the International Classification of Headache Disorders definition and diagnostic criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 4 weeks from week 4 (weeks 1-4) to week 24 (weeks 21-24)
Awards & highlights

E-BEOND Trial Summary

This trial will test if Dysport® (BoNT-A) injections can safely and effectively prevent episodic migraines. Participants will get injections of Dysport® or placebo over 14 months & record their symptoms.

Who is the study for?
Adults over 18 with a history of episodic migraines (less than 15 headache days per month, but at least 6 migraine days). They must have had migraines start before age 50 and been diagnosed for over a year. Participants can't join if they've used certain medications or treatments recently, like other botulinum toxins or migraine devices.Check my eligibility
What is being tested?
The trial is testing Dysport®, a Botulinum toxin type A formulation, against a placebo to see if it prevents episodic migraines. It involves two treatment phases: the first with Dysport® or placebo injections and the second where all get Dysport®. There are clinic visits, remote check-ins, e-diaries, questionnaires, blood tests and physical exams.See study design
What are the potential side effects?
Dysport® may cause muscle weakness near injection sites, eyelid drooping, skin reactions at the injection site such as pain or bruising; less commonly there could be symptoms affecting the whole body like tiredness or headaches.

E-BEOND Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years or older and can sign consent forms.
Select...
I have been diagnosed with migraine, with or without aura, for over a year.
Select...
I have less than 15 headache days but at least 6 migraine days a month.

E-BEOND Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 4 weeks from week 4 (weeks 1-4) to week 24 (weeks 21-24)
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 4 weeks from week 4 (weeks 1-4) to week 24 (weeks 21-24) 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 monthly migraine days (MMD)
Secondary outcome measures
Change from baseline in MHD of moderate or severe intensity of ≥50%
Change from baseline in MHD of moderate or severe intensity of ≥75%
Change from baseline in MMD of moderate or severe intensity
+24 more

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

E-BEOND Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Dysport® dose "B"Experimental Treatment1 Intervention
Participant will receive four treatment cycles, each separated by an interval of 12 weeks. DBPC Phase: Dysport® dose "B" administered intramuscularly on Day 1 and Week 12. Extension Phase: Dysport® dose "B" administered intramuscularly at Week 24 and Week 36 (final follow-up at Week 48)
Group II: Dysport® dose "A"Experimental Treatment1 Intervention
Participant will receive four treatment cycles, each separated by an interval of 12 weeks. Double-blind placebo-controlled (DBPC) Phase: Dysport® dose "A" administered intramuscularly on Day 1 and Week 12. Extension Phase: Dysport® dose "A" administered intramuscularly at Week 24 and Week 36 (final follow-up at Week 48)
Group III: Placebo - Dysport dose "A"Placebo Group2 Interventions
Participant will receive four treatment cycles, each separated by an interval of 12 weeks. DBPC Phase: Placebo dose "A" administered intramuscularly on Day 1 and Week 12. Extension Phase: Dysport® dose "A" administered intramuscularly at Week 24 and Week 36 (final follow-up at Week 48).
Group IV: Placebo - Dysport dose "B"Placebo Group2 Interventions
Participant will receive four treatment cycles, each separated by an interval of 12 weeks. DBPC Phase: Placebo dose "B" administered intramuscularly on Day 1 and Week 12. Extension Phase: Dysport® dose "B" administered intramuscularly at Week 24 and Week 36 (final follow-up at Week 48).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Botulinum toxin type A
2011
Completed Phase 4
~2730

Find a Location

Who is running the clinical trial?

IpsenLead Sponsor
346 Previous Clinical Trials
72,587 Total Patients Enrolled
1 Trials studying Migraine
138 Patients Enrolled for Migraine
Ipsen Medical DirectorStudy DirectorIpsen
258 Previous Clinical Trials
54,576 Total Patients Enrolled
1 Trials studying Migraine
138 Patients Enrolled for Migraine

Frequently Asked Questions

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

Has the FDA sanctioned Dysport® dose "A" for public use?

"Clinical data has been gathered to support the safety of Dysport® dose "A", resulting in a rating of 3 on our internal scale. This Phase 3 trial also indicates some efficacy, which adds further credence to its value as a safe treatment option."

Answered by AI

Are there remaining vacancies for individuals to participate in this clinical trial?

"Indeed, according to information accessible on clinicaltrials.gov, this medical experiment is presently searching for participants. It was initially posted on September 29th 2022 and the most recent modification happened on October 9th 2021. A total of 714 patients must be recruited from seven distinct locations."

Answered by AI

How many individuals have volunteered to participate in this research project?

"Affirmative, per the clinicaltrials.gov record this trial is currently attempting to acquire volunteers. The initial posting was on September 29th 2023 and it has since been updated as recently as October 9th 2023. This research requires 714 participants that can be sourced from seven different sites."

Answered by AI

How many medical centers are engaged in executing this investigation?

"The clinical trial sites involved are Visionary Investigators Network (VIN) in Aventura, Robbins Headache Clinic in Riverwoods, MD Fort Wayne Neurological Center in Fort Wayne, and 4 other operating locations."

Answered by AI

Who else is applying?

What site did they apply to?
Fullerton Neurological Center
North Texas Institute of Neurology & Headache
Thomas Jefferson University Hospital - Jefferson Hospital for Neuroscience - Jefferson Neurology Associates - Neurology
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Episodic Migraine in Adults
2023. "A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Episodic Migraine in Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06047457.
All > Migraine Headaches > Knoxville
~476 spots leftby Jun 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top