Are migraines impacting your life?
Consider joining one of the BEOND studies for people living with migraine.
Medical Condition:
Participation Duration:
Phase:
What is a Migraine?
A migraine is a headache with severe throbbing pain or a pulsating sensation, usually on one side of the head, and is often accompanied by feeling or being sick and a sensitivity to bright lights and sound. Chronic Migraine is defined as having at least 15 days of headache a month with at least 8 of those days being migraine headache days, whereas Episodic Migraine is defined as having less than 15 days of headache a month with at least 6 days with migraine headaches. Migraines are caused by a series of events which cause the brain to get stimulated/activated, which results in the release of chemicals that cause pain.
What are the BEOND clinical studies?
The BEOND studies are researching an investigational drug for patients with migraine. There are two studies: one study on chronic migraine and one study in episodic migraine. The goal of these studies is to determine if the investigational drug is safe and effective for people living with migraines.
The two studies are focused on assessing the efficacy and safety for an investigational use of Dysport® which is a formulation of Botulinum toxin type A (BoNT-A). Through research it is believed that Dysport® (abobotulinumtoxin A) may work on the release of the chemical messengers causing migraine pain.
Dysport® is not approved by health authorities (such as the US Food and Drug Administration (FDA)) for the treatment of migraine. Our researchers now want to assess its potential for this use.
Who can participate?
The clinical studies are seeking patients with migraine. You may be eligible to participate if you:
Are 18 years old or older
Have had a diagnosis of Migraine for at least 1 year
Experience at least 6 migraines per month
Please note there are more eligibility criteria that must be met to be considered for participation.
What happens if I participate?
If you are eligible and decide to take part in one of the clinical studies, you will be randomly assigned to get either the investigational drug or placebo (a substance that does not contain active ingredients). You and your study doctor will not know which study medicine you are getting.
Whether or not you decide to join the clinical research study is completely up to you and you can withdraw consent at any time and for any reason. You may be reimbursed for travel costs to the study site.
01
Screening Period
This is the time when the study doctor and staff determine if you are eligible, and you decide if you want to participate. This step takes 6 weeks and if you take other medication for migraine, the study will take another 6 weeks for you to not be on these other medications.
02
Study Treatment Period
This period will last approximately 24 weeks. On the first day and after 3 and 6 months in the Treatment Period, you will receive injections into various muscles. The injections will contain either Dysport® or a placebo (an inactive substance or treatment that looks the same as and is given in the same way as the investigational drug). You will make 4 visits to the study site in person and have 4 remote (online) visits, these visits are every 4 weeks. During each visit to the study site, you will undergo blood samplings, urine collections, physical examinations, clinical evaluations, and your health will be closely monitored. You will also need to complete an e-diary and questionnaires throughout the study on a daily basis.
03
Extension Treatment Period
The Extension Treatment Period will last approximately 24 weeks. If eligible, you will receive Dysport® injections after 3 months into the extension treatment period. There will be 3 in person visits and 4 remote visits. During each visit to the study site, you will undergo blood samplings, urine collections, physical examinations, clinical evaluations, and your health will be closely monitored.
How do I participate?
1
Complete
the online questions to see if you pre-qualify
2
Submit
your contact information
3
Answer
our call to answer more questions and learn about the study
4
Confirm
your interest and study site location
5
Speak
with the study site about the next steps to participate
Frequently Asked Questions
What will happen after I complete the online questionnaire?
Should your online questionnaire suggest that you are potentially eligible, a qualified medical professional will contact you to conduct a more comprehensive telephone assessment and further evaluate your eligibility. Upon confirmation of your potential eligibility during the telephone medical assessment, you will be proposed with nearby study sites conducting the clinical studies that you might qualify for. The study site of your choice will be provided with your contact details in order to schedule an appointment to share more details about the study and learn about your medical history.
Where can I find more information about BEOND clinical studies?
If you are interested in learning more about the clinical studies, we encourage you to complete a few questions to help assess if there is a study that could be a match. You can then be referred to a study site in your area to answer all of your questions.
You can also learn more about the Chronic Migraine study here: https://clinicaltrials.gov/study/NCT06047444 or the Episodic Migraine study here: https://clinicaltrials.gov/study/NCT06047457.
What type of study-related medical care is provided during the study?
Any medical care, tests or procedures that are for the purpose of the study will be provided and will be explained by the study site. There is no insurance required to participate. As you will need to visit the study site throughout the duration of the study, there may be travel reimbursement available.
What is a clinical research study?
Clinical studies seek to understand if the benefits of an investigational product outweigh its risk for the treatment of a medical condition.
Clinical studies are scientific studies in which new drugs and treatments are tested for safety and efficacy.
Why is clinical research important?
Clinical research adds to medical knowledge and if approved by a regulatory authority, can help bring new potential treatments to people with medical conditions. To bring new treatments to the public, they need to be assessed in clinical studies, to determine their safety and efficacy.
Clinical studies rely on the participation of volunteers. It can take several years for a new potential treatment to reach the public. Often, this timeline is due to how long it takes to complete the clinical study, which can be due to shortage of participants.
All drugs approved by a regulatory authorities have gone through clinical studies to determine their safety and efficacy.
Who runs clinical studies?
Clinical studies can be sponsored, or funded, by pharmaceutical or biotechnology companies, academic medical centres, voluntary groups, or health care providers. The BEOND program is funded by a pharmaceutical company.
Every clinical study site is led by a principal investigator, who is a medical doctor. Clinical studies also have a research team that may include doctors, nurses, and other health care professionals.
What are the phases of clinical research studies?
Clinical studies are conducted in different phases.
Phase 1: Researchers test an investigational drug in a small group of people for the first time to assess its safety.
Phase 2: The study investigational drug is given to a larger group e.g., 50-200 of people (compared to Phase 1) to start evaluating it’s efficacy and safety.
Phase 3: The study investigational drug is given to large groups e.g., 100s-1000s of people to confirm its efficacy, monitor side effects, compare it to commonly used medications or placebo (an inactive substance), and collect information that will allow the study investigational drug to be used appropriately according to its safety profile.
What is a “placebo”?
“Placebo” is a term used to describe something that looks like the investigational drug but does not contain any active ingredients.