Dysport for Migraine Prevention

(E-BEOND Trial)

Not currently recruiting at 196 trial locations

Overseen By Ipsen Clinical Study Enquiries

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Ipsen

Must be taking: Migraine preventatives

Must not be taking: Botulinum toxin, CGRP antagonists

Disqualifiers: Migraine with brainstem aura, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of Dysport®, a type of botulinum toxin, for migraine prevention. Dysport® blocks chemicals that cause pain during a migraine. Participants will receive injections of either Dysport® or a placebo to determine if it reduces migraine frequency. This study suits individuals who have experienced migraines for over a year, have fewer than 15 headache days a month but at least 6 migraine days, and have previously tried preventive medications. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new migraine treatment.

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but you can continue one migraine preventative treatment as long as the dose is stable for at least 3 months before the study starts. Some medications, like botulinum toxin and CGRP antagonists, must be stopped for a certain period before the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Dysport®, containing Botulinum toxin type A, has been studied for safety in preventing migraines. In one study, 57% of patients reported some side effects, which can vary widely. Common side effects include mild issues like headaches or pain at the injection site. Dysport® is similar to Botox, already used for migraines and known to be safe, suggesting that Dysport® may also be well-tolerated. The advanced stage of this trial indicates that earlier studies have already demonstrated a reasonable safety profile for the treatment. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for migraines?

Researchers are excited about Dysport® for migraine prevention because it offers a potentially more effective and longer-lasting option compared to traditional treatments like oral medications and Botox®. Dysport® is a type of botulinum toxin similar to Botox®, but it may provide different benefits due to its unique formulation and dosing. This treatment is administered intramuscularly and could offer a more targeted approach, reducing the frequency of migraines with fewer side effects. By focusing on specific muscle groups associated with migraine triggers, Dysport® might provide quicker relief and improved patient outcomes.

What evidence suggests that Dysport® might be an effective treatment for episodic migraine?

Research has shown that Dysport®, a type of botulinum toxin, can reduce the frequency and severity of migraines. In this trial, participants will receive either Dysport® dose "A" or "B" or a placebo, with varying dosages to assess its effectiveness. Studies have found that such treatments can lead to fewer migraine days and less severe migraines, with some results showing up to a 27% decrease in migraine intensity. Dysport® works by inhibiting the release of pain-causing chemicals in the brain. Although some studies did not find a significant change in the number of migraine attacks, there was still a noticeable improvement in overall migraine symptoms. The evidence suggests that Dysport® could effectively prevent migraines. ^{2 3 4 6 7}

Who Is on the Research Team?

Ipsen Medical Director

Principal Investigator

Ipsen

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have kept track of your symptoms in a diary for at least 22 days before starting the study.

My migraines started before I turned 50.

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

Exclusion Criteria

I have a history of specific severe headaches.

I haven't used CGRP antagonists or cannabinoids for migraine prevention in the last 12 weeks.

I haven't used certain migraine treatments or painkillers extensively in the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

6 to 12 weeks

1 visit (in-person)

Treatment Phase 1

Participants receive injections of Dysport® or placebo into various muscles across the head, neck, face, and shoulders. Injections occur on Day 1 and at Week 12.

24 weeks

4 visits (in-person), 4 visits (virtual)

Treatment Phase 2 (Extension)

All participants receive Dysport® injections at Week 24 and Week 36.

24 weeks

3 visits (in-person), 4 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion.

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dysport®

Trial Overview 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.

How Is the Trial Designed?

Group I: Dysport® dose "B" Experimental Treatment 1 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 Treatment 1 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 Group 2 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 Group 2 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).

Dysport® is already approved in European Union, United States for the following indications:

Approved in European Union as Dysport for:

• Cervical dystonia
• Muscle spasms and stiffness (spasticity) of the arms, hands, legs, and feet
• Facial wrinkles

Approved in United States as Dysport for:

• Cervical dystonia
• Muscle spasms and stiffness (spasticity) of the arms, hands, legs, and feet
• Facial wrinkles

Who Is Running the Clinical Trial?

Ipsen

Lead Sponsor

Trials

358

Recruited

74,600+

David Loew

Ipsen

Chief Executive Officer since 2020

BA in Business Administration and MBA from the University of St. Gallen, Switzerland

Sandra Silvestri

Ipsen

Chief Medical Officer since 2023

MD, PhD

Published Research Related to This Trial

BoNTA-ABO (Dysport) significantly improved moderate to severe glabellar lines compared to placebo, with effects noticeable as early as 24 hours after treatment and lasting a median of 85 days for fixed doses and 109 days for variable doses.

The treatment was effective across a diverse group of 1116 patients, with no evidence of tolerance developing after multiple treatment cycles, suggesting sustained efficacy over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An analysis of efficacy data from four phase III studies of botulinum neurotoxin type A-ABO for the treatment of glabellar lines. Baumann, L., Brandt, FS., Kane, MA., et al.[2022]

In a study of 65 chronic migraine patients treated with onabotulinumtoxinA (Botox®) over three years, there was a significant reduction in the mean number of monthly headache days, from 7.2 to 3.4 days, indicating sustained efficacy of the treatment.

The therapy was found to be safe and well tolerated, with low rates of adverse events and drop-outs, supporting the long-term use of onabotulinumtoxinA for chronic migraine management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained onabotulinumtoxinA therapeutic benefits in patients with chronic migraine over 3 years of treatment. Vikelis, M., Argyriou, AA., Dermitzakis, EV., et al.[2022]

An open-label study was conducted to assess the safety and effectiveness of botulinum toxin type A injections in patients with chronic migraine who did not respond to at least three different prophylactic medications.

The study highlights the potential of botulinum toxin type A as a treatment option for chronic migraine sufferers, particularly those who have not found relief with standard preventive therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botox therapy for refractory chronic migraine. Conway, S., Delplanche, C., Crowder, J., et al.[2010]

In a study of 59 patients, both botulinum toxin type A (BoNTA) and divalproex sodium (DVPX) effectively reduced migraine-related disability and headache frequency, showing significant improvements in migraine disability scores.

BoNTA was better tolerated than DVPX, with fewer patients experiencing adverse events (50% for BoNTA vs. 75.8% for DVPX) and a much lower discontinuation rate due to side effects (3.3% for BoNTA vs. 27.6% for DVPX).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botulinum toxin type A and divalproex sodium for prophylactic treatment of episodic or chronic migraine. Blumenfeld, AM., Schim, JD., Chippendale, TJ.[2013]

In a review of five phase III clinical trials involving 2485 patients, BoNTA-ABO (Dysport) was found to be well tolerated for treating moderate to severe glabellar lines, with treatment-emergent adverse events (TEAEs) similar to those of placebo, except for injection site reactions and ptosis.

The safety profile of BoNTA-ABO showed no cumulative issues over time, with a decrease in TEAEs during repeat-dose studies, and no significant changes in vital signs or laboratory parameters, indicating its safety for repeated use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An analysis of safety data from five phase III clinical trials on the use of botulinum neurotoxin type A-ABO for the treatment of glabellar lines. Rubin, M., Dover, J., Maas, C., et al.[2016]

In a 12-week study involving 128 patients, Dysport (botulinum toxin type A) did not show a significant reduction in the number of migraine attacks compared to placebo, indicating that its efficacy for this primary endpoint remains inconclusive.

However, Dysport-240 units demonstrated significant improvements in headache duration and intensity during the first 4 weeks, suggesting potential benefits that warrant further investigation with better assessment tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prophylactic botulinum type A toxin complex (Dysport®) for migraine without aura. Chankrachang, S., Arayawichanont, A., Poungvarin, N., et al.[2011]

A phase 3b clinical trial involving 134 adults with cervical dystonia demonstrated that a 500 U/2 mL dilution of abobotulinumtoxinA significantly improved symptoms compared to placebo, with a notable treatment difference of -8.3 on the Toronto Western Spasmodic Torticollis Rating Scale (P < 0.001).

The safety profile of the 500 U/2 mL dilution was consistent with previous data for the 1 mL dilution, with common side effects including dysphagia, muscle weakness, neck pain, and headache, indicating that the new dilution is both effective and safe for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 500 U/2 mL dilution of abobotulinumtoxinA vs. placebo: randomized study in cervical dystonia. Lew, MF., Brashear, A., Dashtipour, K., et al.[2018]

Dysport, a new botulinum neurotoxin type A approved by the FDA in 2009, offers a therapeutic alternative to Botox, and both can be used for similar cosmetic and medical applications.

Understanding the differences between Dysport and Botox, including their unit conversions and injection techniques, is crucial for practitioners to minimize side effects and achieve the best results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical applications of a new botulinum toxin. Hexsel, D., Spencer, JM., Woolery-Lloyd, H., et al.[2010]

In the COMPEL Study involving 716 adults with chronic migraine, onabotulinumtoxinA treatment every 12 weeks for 108 weeks resulted in a significant reduction in headache days, with an average decrease of 10.7 days by the end of the study (P < 0.0001).

The treatment was found to be generally safe and well-tolerated, with only 18.3% of patients reporting adverse events, the most common being neck pain, and no deaths reported, indicating a favorable risk-benefit profile for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term study of the efficacy and safety of OnabotulinumtoxinA for the prevention of chronic migraine: COMPEL study. Blumenfeld, AM., Stark, RJ., Freeman, MC., et al.[2018]

In a trial with 32 participants suffering from high-frequency episodic migraines, onabotulinum toxin-A treatment led to a significant reduction of 3.68 migraine days per month, which is a 33.1% decrease from baseline.

The treatment also improved patients' quality of life and reduced the need for acute medication, with 39% of participants experiencing at least a 50% reduction in monthly migraine days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BoNT-A efficacy in high frequency migraine: an open label, single arm, exploratory study applying the PREEMPT paradigm. Martinelli, D., Arceri, S., De Icco, R., et al.[2022]

OnabotulinumtoxinA is the first medication specifically approved to prevent chronic migraines (CM), based on two phase 3 clinical studies involving over 5000 patients, which demonstrated significant reductions in headache frequency compared to placebo.

The treatment not only effectively reduces migraine days but also improves quality of life and is well tolerated, with most side effects being mild or moderate and decreasing with continued use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of chronic migraine with Botox (onabotulinumtoxinA): Development, insights, and impact. Turkel, CC., Aurora, S., Diener, HC., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06047444

NCT06047444 | A Study to Evaluate the Effectiveness and ... The purpose of this study is to understand the safety and effectiveness of the study drug, Dysport® when compared with placebo in preventing chronic ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21083558/

Prophylactic botulinum type A toxin complex (Dysport®) for ... Results: Change in number of migraine attacks from pre-treatment to weeks 8-12 was not significantly different. There was a greater improvement in total ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06047457/a-study-to-evaluate-the-effectiveness-and-safety-of-dysportr-for-the-prevention-of-episodic-migraine-in-adults

A Study to Evaluate the Effectiveness and Safety of Dysport ... The purpose of this study is to understand the safety and effectiveness of the study drug, Dysport® when compared with placebo in preventing episodic migraine.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0041010124000424

Exploring the Therapeutic Potential of AbobotulinumtoxinA ... AboBoNT-A and onaBoNT-A recipients reported an average of 23% (SD: 12.8) and 27% (SD: 8.9) reduction in migraine severity, respectively. Although there were no ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6661560/

Cochrane systematic review and meta-analysis of botulinum ... We have data which suggest that BTX effectively reduces the duration and severity of migraines in sufferers. There are however question marks ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2016/125274s107lbl.pdf

DYSPORT® (abobotulinumtoxinA) for injection In the overall safety database, where some patients received up to twelve treatments with DYSPORT®, adverse reactions were reported for 57% (1425/2491) of ...

7. withpower.com withpower.com/trial/phase-3-migraine-disorders-8-2023-4e3a0

Dysport for Migraine Prevention (E-BEOND Trial) While specific safety data for Dysport is limited in the provided research, similar treatments like onabotulinumtoxinA (Botox) have shown a good safety profile ...