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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

Summary

This trial aims to test the safety and effectiveness of Dysport® in preventing chronic migraines. Dysport® is a drug that blocks pain-causing chemicals in the brain. Dysport® has shown good results in previous studies for preventing migraines. The study focuses on people who have frequent and severe migraines, with injections given over a period of more than a year.

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.
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.
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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in monthly migraine days (MMD)
Secondary study objectives
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

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Botulinum toxin type A, such as Dysport®, works by inhibiting the release of neurotransmitters that cause pain, specifically targeting the chemicals involved in migraine pathophysiology. This is crucial for migraine patients as it directly addresses the root cause of pain, potentially reducing the frequency and severity of migraine attacks. Other common treatments include medications like triptans, which constrict blood vessels and block pain pathways in the brain, and preventive medications such as beta-blockers and anticonvulsants, which stabilize neural activity. Understanding these mechanisms helps patients and doctors choose the most effective treatment tailored to the individual's specific migraine triggers and symptoms.
[Botulinum toxin type A in headache treatment : Established and experimental indications].

Find a Location

Who is running the clinical trial?

IpsenLead Sponsor
349 Previous Clinical Trials
73,082 Total Patients Enrolled
1 Trials studying Migraine
138 Patients Enrolled for Migraine
Ipsen Medical DirectorStudy DirectorIpsen
259 Previous Clinical Trials
55,083 Total Patients Enrolled
1 Trials studying Migraine
138 Patients Enrolled for Migraine
~472 spots leftby Jun 2026
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