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The newly announced prospective, randomized, placebo- and sham-controlled study, will include 150 patients, ages 18 to 55 years, with documented patent foramen ovale and a history of more than 1 migraine headache day per week.
Robert Sommer, MD
WL Gore & Associates, also known as Gore, recently announced it has initiated a new study—RELIEF (NCT04100135)—that will assess whether closing the patent foramen ovale (PFO) may provide relief for patients with migraine. Specifically, the trial will evaluate the efficacy and safety of the GORE CARDIOFORM Septal Occluder, a permanently implanted, FDA-approved device.1
RELIEF is expected to include approximately 150 patients ages 18 to 55 years with documented PFO, who will be randomly assigned to either device PFO closure arm or sham. The primary end points of the study are mean reduction in migraine headache days over a 40-week treatment period, and proportion of patients with serious adverse events (AEs) related to the study procedure through 30 days post-procedure.
"No previous PFO closure migraine trial has yet included such clearly defined selection criteria designed to identify those patients expected to most likely respond to this potential, PFO-mediated mechanism," Robert Sommer, MD, principal investigator of RELIEF, said in a statement.1 "Clinical experiences have suggested a platelet-based connection between migraine and PFO, and there may be a correlation between PFO closure responsiveness and thienopyridine responsiveness. PFO closure may offer a mechanical method to reduce or eliminate this trigger factor."
There have been nixed literature on the approach of PFO closure, although observational studies have shown that it is safe and could reduce the frequency and duration of migraine. The GORE CARDIOFORM Septal Occluder, which was approved to reduce the risk of recurrent stroke, includes a minimal, nitinol wire frame covered with ePTFE. It conforms to the adjacent, native anatomy facilitating high closure rates with rapid tissue ingrowth and no reported cardiac erosions. To date, there have been over 60,000 devices sold globally in its 11 years of clinical use.
Patients included in the study will have met International Classification of Headache Disorders–3 diagnostic criteria for migraine with or without aura, have at least 1 year of migraine symptom duration, and must be younger than 50 years of age at migraine onset. Patients will also have tried and failed at least 2 preventive medications, experience at least 1 migraine headache per week, and have presence of PFO as determined by transthoracic echocardiography or transesophageal echocardiography.
In a traditional placebo-controlled trial, Nerivio outperformed placebo in the reduction monthly migraine days and monthly headache days, regardless of chronic or episodic migraine status.
"The RELIEF Clinical Study is another example of Gore's commitment to research with the goal of improving lives,” Jake Goble, PhD, Innovation Leader, and Cardiac Business Leader, Medical Products Division, Gore, said in a statement.1 "The study incorporates the learnings from past PFO-migraine studies targeting a patient population we hypothesize may truly benefit. We are excited to reach this milestone as we continue to pursue a potentially impactful treatment option for migraine headache relief."
The efficacy and safety of PFO closure to improve migraine has been studied before, with results captured in a meta-analysis published earlier this year. In total, 3 randomized controlled trials, 1 pooled study, and 8 retrospective case series including 1165 participants were included. Compared with control intervention, PFO closure showed a significant reduction in headache frequency (odds ratio [OR], 1.5698 [95% CI, 1.0465-2.3548; P = .0293) and monthly migraine attacks and monthly migraine days (OR, 0.2594; 95% CI, 0.0790-0.4398; P = .0048). In a subgroup analysis of those who completed PFO surgery, investigators found migraine resolution in patients with aura (OR, 1.5856; 95% CI, 1.0665-2.3575; P = .0227).2
