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Neuromodulator

Dysport for Chronic Migraine (C-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
Has baseline number of monthly headache days (MHD) ≥15 and baseline number of monthly migraine days (MMD) of ≥8, using eDiary data collected during the 4 weeks nearest to randomisation on Day 1 (but prior to randomisation)
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

C-BEOND Trial Summary

This trial aims to understand the safety and effectiveness of Dysport® as a treatment for chronic migraine. Patients will receive injections and complete questionnaires and an e-diary over 14 months.

Who is the study for?
Adults over 18 with chronic migraine, defined as at least 15 headache days a month and at least 8 of those being migraines. Participants must have had migraines start before age 50 and be diagnosed for more than a year. They can't join if they've used certain medications or treatments recently, like other botulinum toxins, CGRP antagonists, cannabinoids, or neuromodulation therapies.Check my eligibility
What is being tested?
The trial is testing Dysport®, a Botulinum toxin type A medication against placebo to prevent chronic migraines. It involves two treatment phases over approximately 14 months with injections into head and neck muscles every 12 weeks. Participants will also keep an e-diary and complete questionnaires.See study design
What are the potential side effects?
Dysport® may cause muscle weakness near the injection site, eyelid drooping, skin tightness or pain where injected, headaches not related to migraines, allergic reactions like itching or rash, and less commonly breathing difficulties.

C-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 15 or more headache days and 8 or more migraine days a month.

C-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 HIT-6 score to MID/MIC
Change from baseline in MHD of moderate or severe intensity of ≥50%
Change from baseline in MHD of moderate or severe intensity of ≥75%
+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

C-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 "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).
Group IV: 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)
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
72,580 Total Patients Enrolled
1 Trials studying Migraine
138 Patients Enrolled for Migraine
Ipsen Medical DirectorStudy DirectorIpsen
258 Previous Clinical Trials
54,569 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 U.S. Food and Drug Administration endorsed a certain dosage of Dysport®?

"Our team has calculated the safety of Dysport® dose "A" to be a 3 on a scale from 1-3, as it is currently in Phase 3 trials. This signifies that there are multiple rounds of data confirming its efficacy and safety."

Answered by AI

In what areas can individuals access this research?

"This medical trial is currently recruiting from 7 sites, including Aventura, Riverwoods and Fort Wayne. To diminish the need for travel it would be advisable to look for a site in close proximity."

Answered by AI

Are participants already being accepted for this clinical investigation?

"This medical experiment, which was first listed on the 1st of October 2023, is not currently recruiting. However, 169 other clinical trials are actively enrolling participants at this time."

Answered by AI

Who else is applying?

What site did they apply to?
840037
Thomas Jefferson University Hospital - Jefferson Hospital for Neuroscience - Jefferson Neurology Associates - Neurology
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Chronic Migraine in Adults
2023. "A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Chronic Migraine in Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06047444.
All > Migraine Headaches > Vancouver
~480 spots leftby Jun 2026
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