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Two new studies now enrolling participants will examine a new botulinum toxin-based treatment for migraine headaches.
Migraine headaches are debilitating, painful, and unique to each person who experiences them. To provide effective, personalized treatment, we must have various treatment options. MedStar Health Research Institute is now enrolling participants in two studies of a new medication that could give patients and providers more versatility in treatment.
The studies, E-BEOND and C-BEOND, are Phase III clinical trials testing the safety and effectiveness of Dysport®, a form of Botulinum toxin type A, for preventing migraines.
C-BEOND will examine Dysport for chronic migraine (at least 15 days of headaches, 8 of which were migraines, per month), while E-BEOND focuses on episodic migraine (fewer than 15 headache days per month with at least six days being migraine days).
The American Migraine Foundation estimates that at least 39 million people in the U.S. live with migraine. But many go undiagnosed, so that number is probably low. Our research could help develop new, effective treatments, and participants will have early access to therapies that could relieve migraine symptoms.
Understanding new migraine treatment options.
People who enroll in these trials will receive either Dysport or a placebo. They will have in-person and remote appointments for physical exams, blood and urine sample collection, and Dysport injections. An electronic diary and questionnaires will help track their progress over the 14 months of the trial.
Participants who are assigned a placebo will have an opportunity to transition to the medication, so everyone will have a chance to receive treatment.
To enroll, patients must be adults over age 18 who speak English. They must have had a diagnosis of migraine for at least a year, and their migraines must have started before the age of 50. To learn more about our study and whether you can participate, call 202-877-8125.
Related reading: Everything You Need to Know About Migraines and How to Treat Them.
Dysport: A new kind of Botulinum toxin for headache.
Dysport is a form of Botulinum toxin type A, a neurotoxin that can cause temporary paralysis. It is similar to Botox, which was approved for migraine treatment in 2011.
To treat headaches, Botulinum toxin is precisely injected under the skin into the tip of muscles near the sensory nerves. During a migraine, these nerves send distress signals to the brain, making patients extremely sensitive to external stimulation like light and sound. The toxin calms this nerve, quieting signals that result in migraine symptoms.
We’re studying Dysport to learn which doses are most effective and whether it might have fewer side effects than Botox, which can leave some patients with neck and muscle pain. In some patients, Botox can trigger a migraine and, in rare cases, can cause weakness at the injection site or in the neck.
If it’s proven safe and effective, Dysport could become an essential new tool for providers to help patients avoid the burden of migraine attacks.
Related reading: New Headache Research: Atogepant Could Be a Safe, Effective Medicine to Prevent Migraines.
Building our migraine treatment toolkit.
Preventative migraine treatment can help patients get back to leading full lives, but some patients may only get partial relief with current options. Fifty percent fewer migraine days is an improvement, but it still leaves patients in a lot of pain.
At the MedStar Georgetown University Headache Center, we partner with patients to develop a personalized treatment plan. Along with lifestyle changes and physical therapy, this plan can include a toxin-based medication like Botox or Dysport in addition to a medication like atogepant that works differently – by blocking calcitonin gene-related peptide, a protein related to pain transmission that spikes during a migraine attack.
Because migraine treatment is so personal, providers must have various safe, effective treatment options to help our patients lead full, active lives. These studies of Dysport are an essential step toward that goal.
