Dysport for Chronic Migraine

(C-BEOND Trial)

Not currently recruiting at 235 trial locations

Overseen By Ipsen Clinical Study Enquiries

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Ipsen

Must be taking: Preventive treatments

Must not be taking: Botulinum toxin, CGRP antagonists, Cannabinoids, others

Disqualifiers: Migraine with aura, Secondary headaches, 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 aims to test the safety and effectiveness of Dysport®, a medication made from Botulinum toxin type A (BoNT-A), in preventing chronic migraines compared to a placebo. Chronic migraines are intense headaches that occur at least 15 days a month, with 8 of those being migraine days. Participants will receive injections of either Dysport® or a placebo over two treatment phases. This trial may suit those who have experienced migraines for over a year and have at least 15 headache days per month. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking 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 may need to stop certain ones. For example, you cannot use botulinum toxin for 24 weeks before the trial, and some other medications like CGRP antagonists and cannabinoids have specific timeframes. You can continue one migraine preventative treatment if the dose is stable for at least 3 months before the trial.

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

Research has shown that Dysport®, a type of Botulinum toxin type A, is generally safe for people. In past studies, patients tolerated it well, even when used to prevent migraines. Most side effects, such as mild pain or swelling at the injection site, were not serious.

Other studies found that Dysport® did not significantly increase migraine attacks, suggesting it doesn't worsen the condition. Some reports mention minor side effects, but these are usually easy to manage.

Overall, evidence suggests Dysport® is a well-tolerated treatment option for chronic migraines, with a good safety record in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Dysport® for chronic migraine because it offers a different approach from traditional oral medications like triptans and beta-blockers. Dysport® is a form of botulinum toxin type A, which is injected directly into specific muscles, potentially reducing migraine frequency and severity by targeting nerve signaling pathways that trigger pain. This method of delivery allows for localized treatment and could lead to fewer systemic side effects compared to oral treatments. Additionally, Dysport® offers a long-lasting effect, with treatment cycles spaced 12 weeks apart, which could mean fewer doses and greater convenience for patients.

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

Studies have shown that Dysport®, which contains Botulinum toxin type A, can effectively prevent chronic migraines. Research indicates that this treatment reduces migraine severity by about 23-27%. Additionally, Dysport® significantly decreases the number of headache days each month, reducing them by an average of 8 to 9 days from the baseline. In this trial, participants will receive either Dysport® at dose "A" or dose "B", or a placebo, to evaluate its effectiveness in reducing the frequency and intensity of chronic migraines. ^{1 2 3 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 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.

Inclusion Criteria

You have kept a diary for at least 22 days in the 4 weeks leading up to the start of the study.

I have been diagnosed with chronic migraines for over a year.

My migraines started before I turned 50.

Exclusion Criteria

I have headaches, but they are not caused by another condition, except for medication overuse.

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

I haven't used certain migraine treatments or painkillers frequently in the last 4 weeks.

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 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.

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dysport®
• Placebo

Trial Overview 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.

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

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]

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]

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 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]

In a study of 33 patients with intractable chronic migraines who had not responded to other treatments, Botox® injections led to a significant reduction in headache impact, as measured by the HIT-6 score, indicating its efficacy for this difficult-to-treat condition.

21% of the patients experienced a sustained reduction in their HIT-6 scores below 60, suggesting that Botox® can provide meaningful relief for some individuals suffering from chronic migraines, even when they have no pain-free time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of botulinum toxin type-A for intractable chronic migraine patients with no pain-free time. Atraszkiewicz, D., Ito, R., Bahra, A.[2023]

A survey of 64 headache centers in Italy revealed that Onabotulinumtoxin A (OBT-A) is widely used for chronic migraine treatment, with 98.4% of centers using it for over a year and following the recommended PREEMPT treatment guidelines.

Most clinicians define a positive response to OBT-A as a 30% to 50% reduction in headache days, and 80% believe that early treatment leads to better outcomes, suggesting OBT-A could be considered a first-line therapy for chronic migraine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Onabotulinumtoxin A for the management of chronic migraine in current clinical practice: results of a survey of sixty-three Italian headache centers. Tassorelli, C., Aguggia, M., De Tommaso, M., et al.[2022]

In a study of 175 patients with chronic migraine, increasing the dose of onabotulinumtoxinA from 150 units to 200 units significantly reduced the number of headache days and severe headache days, indicating improved efficacy with higher doses.

The higher dose of onabotulinumtoxinA also led to a decrease in the duration of 'wearing off' periods, suggesting that patients experienced more consistent relief from migraines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OnabotulinumtoxinA in chronic migraine: is the response dose dependent? Zandieh, A., Cutrer, FM.[2022]

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]

In a study of 60 patients with refractory chronic migraine, both 15-point Dysport and 31-point Xeomin injections significantly reduced headache frequency, duration, intensity, and improved headache impact test (HIT) scores over 3 months, indicating their efficacy in treating migraines.

While Dysport injections showed a slightly greater reduction in HIT scores compared to Xeomin, the difference was not statistically significant, suggesting both treatments are comparably effective, but Dysport may offer increased comfort and lower costs due to fewer injection points.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel technique of botulinum toxin injection around skull sutures for chronic migraine: A randomized controlled clinical trial. Hemasian, H., Abedini, F., Arab, A., et al.[2023]

OnabotulinumtoxinA has been shown to be an effective and well-tolerated preventive treatment for chronic migraine, based on randomized clinical trials using fixed-site and fixed-dose injections (155-195 U).

The proposed mechanism of action for onabotulinumtoxinA involves inhibiting the release of certain pain-related substances in the trigeminovascular system, although the exact pathomechanism of chronic migraine remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Chronic Migraine with OnabotulinumtoxinA: Mode of Action, Efficacy and Safety. Szok, D., Csáti, A., Vécsei, L., et al.[2018]

Botulinum toxin type A has been shown to be an effective prophylactic treatment for chronic migraine, providing benefits over placebo in a specific subset of patients.

This treatment is particularly important as existing migraine therapies often have limited efficacy and can cause systemic side effects, highlighting the need for alternative strategies for chronic migraine sufferers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botulinum toxin type A for the treatment of migraine. Aurora, S.[2019]

Citations

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

Study: Dysport for Chronic Migraine Prevention 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 Toxin A for Migraine Without Aura 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

Dysport for Episodic Migraine: Effectiveness & Safety Study 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. botoxone.com botoxone.com/chronic-migraine/efficacy

Chronic Migraine - Efficacy Proven prevention in Chronic Migraine with significant headache (HA) day reductions. 1-3 8 to 9 fewer headache days per month from baseline.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10223125/

Safety of Onabotulinumtoxin A in Chronic Migraine The results demonstrate that the incidence of bleeding was 0.9% in patients receiving antithrombotic therapy after the treatment with ...

7. withpower.com withpower.com/trial/phase-3-migraine-disorders-8-2023-2950b

Dysport for Chronic Migraine · Info for Participants The safety of Dysport (AbobotulinumtoxinA) for chronic migraine has been evaluated, and it is generally considered safe for humans. Adverse events (unwanted ...