IHC 2021 | Updates on the Phase III TEAM study of CEFALY for migraine treatment

And so the TEAM study was conducted as a multicenter study at 10 different sites in the United States. It was a randomized sham-controlled study that specifically looked at the acute treatment of migraine. In this particular… Two different acute treatment studies were conducted. The study that was completed earlier to this looked at the use of the device in the clinical setting. And so in the first study, prior to the team study for the acute treatment of migraine, we had patients or participants in the trial contact us when they had a migraine attack and had them come into our research study center and we monitored them using the device for that migraine attack for the acute treatment.

Based on the findings of that initials study, which has already been published, we went on for the TEAM study, which is the second part of this study for the acute treatment of migraine, where patients were able to take the device home with them and use it in the comfort of their home rather than coming into the clinical setting. So patients were instructed to use the device with an individual migraine attack when the pain was moderate to severe. And basically, what we looked at was very similar to what’s looked at in many acute treatment pharmaceutical trials. There were two main primary endpoints, pain freedom at two hours and freedom from the most bothersome symptoms at two hours. So those were both the primary endpoints that we were mainly looking at.

The secondary endpoints included pain relief at two hours, absence of all migraine-associated symptoms, that photophobia, phonophobia, and nausea at two hours, the use of acute medications within 24 hours after using the CEFALY device, sustained pain freedom at 24 hours, and sustained pain relief at 24 hours. So we had like seven different endpoints, but two of them were our primary endpoints with that pain freedom at two hours and freedom from the most bothersome migraine-associated symptom at the two-hour mark.

And so in the study, the clinical trial did meet both primary endpoints. We found that folks who received active stimulation had more pain freedom at two hours than the folks who received the sham stimulation. That was statistically significant. And we also found that the folks who got the active stimulation also had more freedom from their most bothersome symptom at two hours compared to this sham stimulation.

I think first, the first thing is that really talking to patients about what they’re interested in from a treatment standpoint is very important. Previously when I discussed treatment options with patients, I had a whole set script of when I would discuss pharmaceutical treatments for the prevention and acute treatment of migraine. And then at the end of this very long conversation, the patient would tell me, “But I want to try something that’s noninvasive or non-pharmaceutical first.” So now I’ve learned a big lesson that I should ask patients what their expectations are for the prevention of migraine, what their expectations are for the acute treatment of migraine, and also discuss noninvasive options such as devices, discuss non-pharmaceutical options such as vitamins, and also discuss those mainstream evidence-based pharmaceutical treatments. So now I’ve expanded my conversation to include some of these more noninvasive things that may cause less side effects.

In our clinical trial, we did find that the CEFALY device can cause a different forehead sensations. No serious adverse events were encountered in the study and patients in the active arm did report some paraesthesia, some tingling, some discomfort in burning in around, I believe in the active arm it was around nine patients, and in the sham, it was one patient. So that’s the most common thing I hear about in my practice as well. So I counsel them about that and I always discuss all the… With all medications I recommend, I discuss those side effects and sometimes the patient just prefers a device. So I think it’s important to expand that conversation with patients.