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Take part in a Research Study!
Are you living with migraine and willing to contribute to research on new preventive options?
You are invited to check your eligibility in a clinical trial studying the efficacy and safety of Abobotulinum toxin A injections as an investigational (not FDA approved) preventive treatment for migraine. This study provides an opportunity to contribute to research that could bring valuable information into how migraine is managed.
Why participate in this study?
As a participant, you will:
- Receive Abobotulinum toxin A injections as part of the study protocol.
- Help contribute to medical knowledge about migraine treatments.
- Be monitored by study-related healthcare professionals throughout the study.
- Observe whether the investigational treatment has an effect on the frequency and intensity of your attacks if you are receiving the active treatment.
About the study treatment
Abobotulinum toxin A (Dysport®) is an investigational treatment in which the efficacy and safety of it is being studied in the prevention of migraine. It has not been FDA approved for this condition. It is produced from botulinum toxin A (BoNT-A), a neurotoxin derived from the bacterium Clostridium botulinum. Dysport® is already approved for use in other conditions. During the study, very small amounts will be administered at multiple sites on the head, face, and neck. Some participants will receive abobotulinum toxin A throughout the study. Others will receive placebo injections (injections with no active medicine) for 6 months and eventually will be switched to Abobotulinum toxin A.
Who could be eligible?
The E-BEOND Study is recruiting individuals who:
- Are aged at least 18 years.
- Have been diagnosed with migraine with or without aura at least 12 months ago.
- Started to have migraines before the age of 50 years old.
- Typically spend less than 15 days per month with a headache and have at least 6 migraine headaches in a month
- Have used, or are currently using, preventive treatment for migraine.
If you are determined to be eligible for the study, there are other criteria you must meet to join the study, which the study team will discuss with you.
What to expect
During the study, participants will be randomly assigned to one of two groups. One group will receive the actual product for 24 weeks, while the other group will receive a placebo, which is a substance without any active ingredients.
After the first 24 weeks, all participants, regardless of their group, will receive the active treatment. This ensures that researchers are able to gather valuable data.
It’s important to know that all clinical studies may involve risks, including potential side effects or outcomes. If you pre-qualify, the study team will discuss with you potential study-related risks and side effects.
If you join the study, you will:
- Visit the study center to complete your treatment dosing and undergo medical assessments for a total of 60 weeks.
- Be contacted by telephone between study center visits so the site staff can check on your wellbeing.
- Complete a daily headache eDiary to help the study team understand whether the treatment is making a difference to your migraine attacks.
You won’t be charged for any study-related treatment or care.
- Pre-screening: Online questionnaire that you can access by clicking in the button “Check your eligibility” in this email
- Screening: Attend a visit on-site to take the full screening assessment that will determine if you are eligible to participate in the study.
- eDiary: Record your headache and migraine episodes every day for a 6-week screening period first, and then for the entirety of the study if you are accepted in the study.
- 48 Weeks Study: There are study visits onDay 1 and at Week 12, Week 24, Week 36, and Week 48. At Day 1 and Week 12, subjects may get active substance or placebo. At the Week 24 and Week 36 visits, subjects will get active substance. Week 48 will be observation only (no injections) and will be the final study visit.
Check your eligibility now! If you have any questions, please reach out to ebeond@healint.com