What side effects are associated with this type of intervention?

Common treatments for migraines, particularly those similar to Dysport® (Botulinum toxin type A), can have side effects such as neck pain, muscle weakness, and injection site pain. Transcranial magnetic stimulation (TMS) may cause mild adverse events like a warm sensation, arm or hand numbness, and muscle spasms. Noninvasive vagus nerve stimulation (nVNS) can lead to mild device-associated adverse events such as redness, itching, and tingling. Serious adverse events are generally not associated with these treatments.

What prior FDA approvals exist?

Botulinum toxin type A, specifically onabotulinumtoxinA (BOTOX), has been FDA-approved for the preventive treatment of chronic migraine in adults. This treatment works by inhibiting the release of chemical messengers that cause pain. Other related drugs for migraine prevention include calcitonin gene-related peptide (CGRP) monoclonal antibodies, which have also shown efficacy in reducing migraine days and are FDA-approved for this purpose. These treatments are similar to Dysport® in their mechanism of action, targeting the pathways involved in migraine pain.

What other types of research exist?

Calcitonin gene-related peptide (CGRP) antagonists are a promising and novel alternative to Dysport® for migraine patients. These medications have shown efficacy in preventing chronic migraines and are supported by clinical evidence.

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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

Pivotal Trial

Summary

This trial aims to test the safety and effectiveness of Dysport® in preventing episodic migraines. Dysport® is injected into muscles to stop pain-causing chemicals in the brain. The study focuses on people with fewer than 15 headache days per month. Participants will undergo various assessments over a period of more than a year. Botulinum toxin type-A has demonstrated good efficacy in several studies of patients with migraine, although data from some trials have been conflicting.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years or older and can sign consent forms.

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I have been diagnosed with migraine, with or without aura, for over a year.

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I have less than 15 headache days but at least 6 migraine days a month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 4 weeks from week 4 (weeks 1-4) to week 24 (weeks 21-24)

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 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

Head injury

Insomnia

Pain

Asthma

Tachycardia

Constipation

Pyrexia

Cough

Hypertensive crisis

Pneumonia

Vomiting

Fall

Hypokalaemia

Urinary tract infection

100%

80%

60%

40%

20%

Study treatment Arm

Dysport ® 500 U

Placebo

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 3Eligibility criteria met

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

Common treatments for migraines, such as Botulinum toxin type A (e.g., Dysport®), work by inhibiting the release of chemical messengers like calcitonin gene-related peptide (CGRP) that cause pain. This is crucial for migraine patients as it directly targets the pain pathways, potentially reducing the frequency and severity of migraine attacks. Other treatments, like acupuncture, may modulate pain through neurochemical pathways and provide a non-pharmacologic option with fewer side effects. Lifestyle measures, including regular exercise and good sleep hygiene, help manage triggers and overall migraine burden. Understanding these mechanisms allows patients and doctors to choose the most appropriate and effective treatment strategies.

[Botulinum toxin type A in headache treatment : Established and experimental indications].