External Trigeminal Nerve Stimulation device effective for At-Home Acute Migraine Treatment: Phase 3 Clinical Trial

 DARIEN, CEFALY Technology, a Belgium-based manufacturer of wearable medical devices for migraine, today announced the results of a clinical study demonstrating that two-hour treatment with the e-TNS CEFALY device is a safe and effective, non-pharmaceutical alternative for the acute treatment of migraine attacks in the out-of-hospital setting.

The Trial of e-TNS for the Acute treatment of Migraine (TEAM) study was the first, prospective, double-blind,randomized, sham-controlled clinical trial of 2-hour e-TNS treatment for acute migraine attack in an at-home scenario. The TEAM study is also the largest sham-controlled, clinical trial examining the use of any e-TNS therapy for the treatment of migraine headache.

A common and debilitating neurological disorder, migraine has been ranked by the World

Health Organization as the world's second leading cause of disability. There are several limitations to conventional anti-migraine medications. In addition, many patients prefer to avoid medications to treat their migraine headaches. As a result, up to 40% of migraine patients have unmet needs for this migraine treatment.

External trigeminal nerve stimulation (e-TNS) is a medical device treatment that offers a non-pharmacological, non-invasive approach for patients with migraine who prefer to avoid medications, have intolerances to medications or, require complementary therapy in their migraine management. Worn on the forehead, the CEFALY e-TNS device delivers a mild electric stimulation to reduce pain signals of the trigeminal nerve, a primary pathway for migraine pain.

The TEAM study spanned nine months and was conducted at 10 centers across the United States. The study enrolled 538 patients aged 18-65 with episodic migraine, with or without aura, who had moderate- to severe-intensity migraine attacks 2 to 8 times per month. Subjects who met all of the study criteria were randomly assigned to either the verum or sham group and were provided a headache diary and educated with how to use the CEFALY device.

During a 2 month period, patients were instructed to self-administer the e-TNS treatment, according to the training and instruction they received, within 4 hours of migraine onset or within 4 hours of awakening with migraine headache. Neurostimulation was applied with the CEFALY e-TNS device for a 2-hour, continuous session.

In the verum group, compared to the sham group:

Pain freedom at 2 hours was 7.2% higher (25.5% compared to 18.3%; p = .043)

Resolution of the most bothersome migraine-associated symptom was 14.1% higher (56.4% compared to 42.3%; p = 0.001)

Pain relief at 2 hours was 14.3% higher (69.5% compared to 55.2%; p = 0.001)

Absence of all migraine-associated symptoms at 2 hours was 8.4% higher (42.5% compared to 34.1%; p = 0.044)

Sustained pain freedom and pain relief at 24 hours was 7.0% and 11.5% higher in verum (22.8% and 45.9%) than sham (15.8 and 34.4%; p = 0.039)

No serious adverse events were reported.

Study authors concluded that the use of self-administered 2-hour e-TNS therapy is a safe and effective therapeutic option, with or without the use of acute anti-migraine medications.

"The CEFALY device provides patients with a non-medication option for the prevention and acute treatment of migraine. It is especially helpful to add to a medication regimen or use for people who have had a negative experience with migraine medications," said Dr. Deena Kuruvilla, one of the study authors and Medical Director and Board Certified Neurologist, Westport Headache Institute.

"So many people who live with migraine pain are desperate for a solution that they can use safely at home," said Jen Trainor McDermott, CEO of CEFALY Technology. "As the TEAM study shows us, CEFALY provides the powerful, sustained pain relief they need."