Dysport for Migraine Prevention

(E-BEOND Trial)

Recruiting at162 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

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)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug Dysport for migraine prevention?

Research on a similar drug, onabotulinumtoxinA (Botox), shows it can effectively reduce the frequency of chronic migraines and improve quality of life. Dysport, which is another form of botulinum toxin type A, may have similar benefits for migraine prevention. ^{1 2 3 4 5}

Is Dysport (AbobotulinumtoxinA) safe for use in humans?

The safety of Dysport (AbobotulinumtoxinA) for migraine prevention has been evaluated, and it is generally considered safe for use in humans. While specific safety data for Dysport is limited in the provided research, similar treatments like onabotulinumtoxinA (Botox) have shown a good safety profile in studies, with side effects typically being mild or moderate. ^{1 2 4 6 7}

How is the drug Dysport unique for migraine prevention?

Dysport (abobotulinumtoxinA) is unique for migraine prevention because it is a highly purified form of botulinum toxin type A that works by blocking the release of acetylcholine, a chemical that transmits signals between nerves and muscles, which may help reduce migraine frequency. Unlike other treatments, it offers flexibility in injection volume, potentially allowing for more tailored dosing to meet individual patient needs. ^{1 8 9 10 11}

Research Team

Ipsen Medical Director

Principal Investigator

Ipsen

Eligibility Criteria

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

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

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.

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.

Trial Timeline

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

Treatment Details

Interventions

• Dysport® (Botulinum toxin type A)

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.

Participant Groups

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).

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

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Prophylactic botulinum type A toxin complex (Dysport®) for migraine without aura. [2011]

2. England pubmed.ncbi.nlm.nih.gov

Long-term study of the efficacy and safety of OnabotulinumtoxinA for the prevention of chronic migraine: COMPEL study. [2018]

3. England pubmed.ncbi.nlm.nih.gov

BoNT-A efficacy in high frequency migraine: an open label, single arm, exploratory study applying the PREEMPT paradigm. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Treatment of chronic migraine with Botox (onabotulinumtoxinA): Development, insights, and impact. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Botulinum toxin type A and divalproex sodium for prophylactic treatment of episodic or chronic migraine. [2013]

6. England pubmed.ncbi.nlm.nih.gov

Sustained onabotulinumtoxinA therapeutic benefits in patients with chronic migraine over 3 years of treatment. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Botox therapy for refractory chronic migraine. [2010]

8. England 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. [2022]

9. England 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. [2016]

10. England pubmed.ncbi.nlm.nih.gov

A 500 U/2 mL dilution of abobotulinumtoxinA vs. placebo: randomized study in cervical dystonia. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Practical applications of a new botulinum toxin. [2010]