SARASOTA, Fla. – (Oct. 11, 2023) – Migraine affects more than 1 billion people worldwide. Although there are approved treatments, current therapies may not work for everyone, leaving many to experience the disability of migraine attacks.
In an effort to improve treatment outcomes, the Sarasota Memorial Research Institute has joined approximately 25 research sites around the nation testing a combination of two approved migraine therapies – onabotulinumtoxinA and atogepant – to determine if they can safely control migraine more effectively when the treatments are used together.
"By studying the combination of these two approved treatments, we hope to develop new, safe prevention strategies that provide relief for those not helped by current therapies,” said Gregory Hanes, MD, a neurologist with First Physicians Group and principal investigator of the study at Sarasota Memorial.
Atogepant is an oral treatment approved by the FDA in 2021 for the treatment of episodic migraine; the regulatory approval was expanded to chronic migraine in April 2023. Today, it is the only drug of its kind approved to treat both chronic and episodic migraines (chronic migraines are those that occur 15 or more days per month, while episodic migraines occur fewer than 14 days per month). OnabotulinumtoxinA was approved by the FDA in 2010 for prevention of headache in patients with chronic migraine.
The clinical study (NCT05216263) will not involve placebo. Rather, individuals age 18 to 75 who currently are receiving standardized therapy with onabotulinumtoxinA and enrolled in the trial will receive one atogepant tablet daily as an add-on treatment over a 24-week treatment period. The study sponsor, AbbVie Inc., will closely evaluate the safety of combining the therapies and potential to prevent migraines. Approximately 125 participants will be enrolled.
For more information about the trial and enrollment criteria, call the Sarasota Memorial Research Institute at (941) 917-2225 or visit the FDA clinical trial webpage
About the Sarasota Memorial Research Institute
Sarasota Memorial Research Institute (SMRI) provides advanced research services and a highly qualified staff that advances the latest treatment options for patients in our community. Located on Sarasota Memorial Health Care System’s Sarasota campus, the Institute provides the knowledge, expertise, and infrastructure essential to evaluate and manage innovative drug, device, registry, and biospecimen clinical trials. SMRI offers research trials across a wide spectrum of disease processes, including cardiology, infectious disease, gastroenterology, neurology, oncology, pulmonology, urology, vascular, and more. For more information about clinical studies or participating in clinical trials, contact the Sarasota Memorial Research Institute at (941) 917-2225.