What side effects are associated with this type of intervention?

Common treatments for migraines, particularly those similar to Dysport® (Botulinum toxin type A), include Botulinum toxin type A injections and neuromodulation therapies. Botulinum toxin type A can cause mild pain at the injection site, neck pain, and muscle weakness. Neuromodulation treatments like transcranial magnetic stimulation (TMS) and noninvasive vagus nerve stimulation (nVNS) have side effects such as lightheadedness, tingling, tinnitus, warm sensations, numbness, redness, itching, muscle spasms, and pain in the arm, shoulder, or neck. Serious adverse events are rare for these treatments.

What prior FDA approvals exist?

The FDA has approved several treatments for migraine that are similar to Dysport® (Botulinum toxin type A). OnabotulinumtoxinA (BOTOX) is another Botulinum toxin type A formulation that has been approved for the preventive treatment of chronic migraine. It works by inhibiting the release of neurotransmitters involved in pain pathways. Additionally, Calcitonin Gene-Related Peptide (CGRP) monoclonal antibodies, which also target chemical messengers involved in migraine pathophysiology, have been approved for migraine prevention. These treatments provide alternative options for patients who may benefit from therapies that modulate chemical messengers to reduce migraine frequency and severity.

What other types of research exist?

Promising novel alternatives to Dysport® for migraine treatment include CGRP (calcitonin gene-related peptide) inhibitors such as Erenumab (Aimovig), Fremanezumab (Ajovy), and Galcanezumab (Emgality). These medications work by blocking the activity of CGRP, a molecule involved in migraine pathophysiology. Additionally, Gepants like Ubrogepant (Ubrelvy) and Rimegepant (Nurtec ODT) are oral CGRP receptor antagonists that have shown effectiveness in acute migraine treatment. Another emerging option is Lasmiditan (Reyvow), a serotonin (5-HT1F) receptor agonist, which is used for acute migraine relief.

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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

Pivotal Trial

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 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 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

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 / 2Eligibility 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

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].