The clinical data of Nerivio Migra was obtained in one prospective, double-blind, randomized, crossover, sham-controlled pilot study and one multi-center, prospective, randomized, double-blind, sham-controlled pivotal study.
Nerivio Migra: Clinical Data
Full article regarding the pilot study was published in Neurology, March 2017: http://n.neurology.org/content/88/13/e128
The pilot study was a single-center, prospective, double-blind, randomized, crossover, sham controlled pilot study aimed to assess the safety and efficacy of non-invasive remote electrical neuromodulation (REN) with the Nerivio Migra device for the acute treatment of migraine. In this study, 86 people with migraine with or without aura (in accordance with ICHD classification criteria) who had 2–8 attacks per month without preventive medications for at least 2 months were recruited. The participants were requested to treat migraine episodes at home using the device, which randomly provided four different stimuli programs differentiating in pulse width and one sham stimulus. Pain levels were self-reported via a smartphone application at onset and 10, 20, and 120 minutes after stimulation onset. The primary endpoint was the proportion of participants reporting pain decrease of at least 50% at 2 hours post-treatment in at least 50% of completed treatments. The analysis of the primary endpoint was performed on 71 participants who successfully treated at least one migraine attack and have not used rescue medications concurrently with REN treatments. This analysis revealed a 64% rate of at least 50% pain reduction at 2 hours post-treatment, in at least 50% of completed active treatments. This rate was significantly higher than the 26% rate found for the sham treatment (p=0.005). In this study no device-related adverse events and no side effects were reported.
Full article regarding the pivotal study was published in Headache, May 2019: https://onlinelibrary.wiley.com/doi/full/10.1111/head.13551
The pivotal study (TCH-003) was a prospective, randomized, double-blind, sham controlled multi-center study aimed to demonstrate the safety and efficacy of Nerivio Migra 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 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 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. The incidence of device-related adverse events was low (3.6% participants) and similar between 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 were 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 Migra is safe and effective for the acute treatment of migraine. The findings of this study were robust and clinically meaningful. Nerivio Migra, thus, offers a novel alternative for current pharmacological and non-pharmacological treatments that combines effective treatment with minimal side effects.