The results of the pivotal study were published in Headache, May 2019:
The pivotal study (TCH-003) was a prospective, randomized, double-blind, sham controlled multi-center study aimed to demonstrate the safety and efficacy of the Nerivio remote electrical neuromodulation device for the acute treatment of migraine with or without aura. This study was conducted from December 2017 to October 2018 at 12 sites, 7 in the US and 5 in Israel.
296 participants with migraine with or without aura (in accordance with ICHD classification criteria) who had 2–8 attacks per month, ≤12 headache days per month, and were on either no or stable migraine preventive medications in the last two months prior to recruitment were enrolled. 252 participants were randomized to active (n=126) or sham stimulation (n=126). Headache pain levels were reported at baseline, 2 hours and 48 hours post-treatment. The primary efficacy endpoint of the study was the percentage of participants reporting reduction in their pain level, without use of medication, from severe or moderate to mild or no pain or from mild to no pain within 2 hours. Sustained pain relief or pain-free status was defined as having a headache response at 2 hours post-treatment with no use of rescue medication and no return to baseline or relapse of headache pain within 48 hours. The analyses were performed on 202 participants (99 in the active group and 103 in the sham group) who treated an attack within one hour from symptoms onset and reported pain level at 2 hours post-treatment. At 2 hours post-treatment, active stimulation was significantly more effective than sham stimulation in reducing headache pain (66.7% vs. 38.8%, p<0.0001)), in completely relieving headaches (37.4% vs 18.4%, p=0.005), in reducing the most bothersome symptom (MBS) of the associated symptoms of nausea, sensitivity to light and sensitivity to sound (46.3%% vs. 22.2%, p=0.001) and in reducing the combination of headache and MBS (40.0% vs. 15.2%, p<0.001). The 2-hours pain relief and pain-free superiority of the active treatment were sustained 48 hours post-treatment; sustained pain relief at 48 hours post-treatment was achieved by 39.1% of the participants in the active group versus 16.9% in the sham group (p<0.005) and sustained pain free status at 48 hours post-treatment was achieved by 20.7% of the participants in the active group versus 7.9% in the sham group (p<0.005)
Moreover, pain relief at 2 hours post-treatment was consistent across multiple treatments (62.6% of the participants in the active group achieved pain relief in at least 50% of their attacks vs. 45.6% in the sham group, p<0.05).
This study also demonstrated a favorable safety profile for Nerivio. The incidence of device-related adverse events was low (3.6% of participants) and the event rate was similar between the active (Nerivio) and sham treatment groups. During 773 treatments, 23 (2.7%) device-related adverse events were reported, 14 in the active group and 9 in the sham group. All device-related adverse events were mild, did not require treatment and resolved within 24 hours. No device-related serious adverse events were reported and none of the participants withdrew from the study due to adverse events.
In conclusion, the results of the pivotal study indicate that Nerivio is safe and effective for the acute treatment of migraine. The findings of this study were robust and clinically meaningful. Nerivio, thus, offers a novel alternative for current pharmacological and non-pharmacological treatments that combines effective treatment with minimal side effects.