Remote electrical neuromodulation (REN) in the acute treatment of migraine: a comparison with usual care and acute migraine medications

Abstract

Background: There is a significant unmet need for new, effective and well tolerated acute migraine treatments. A recent study has demonstrated that a novel remote electrical neuromodulation (REN) treatment provides superior clinically meaningful pain relief with a low rate of device-related adverse events. The results reported herein compare the efficacy of REN with current standard of care in the acute treatments of migraine.

Methods: We performed a post-hoc analysis on a subgroup of participants with migraine from a randomized, double-blind, parallel-group, sham-controlled, multicenter study on acute care. The original study included a 2-4 weeks run-in phase, in which migraine attacks were treated according to patient preference (i.e., usual care) and reported in an electronic diary; next, participants entered a double-blind treatment phase in which they treated the attacks with an active or sham device. The efficacy of REN was compared to the efficacy of usual care or pharmacological treatments in the run-in phase in a within-subject design that included participants who treated at least one attack with the active REN device and reported pain intensity at 2 h post-treatment.

Results: Of the 252 patients randomized, there were 99 participants available for analysis. At 2 h post-treatment, pain relief was achieved in 66.7% of the participants using REN versus 52.5% participants with usual care (p < 0.05). Pain relief at 2 h in at least one of two attacks was achieved by 84.4% of participants versus 68.9% in usual care (p < 0.05). REN and usual care were similarly effective for pain-free status at 2 h. The results also demonstrate the non-inferiority of REN compared with acute pharmacological treatments and its non-dependency on preventive medication use.

Conclusion: REN is an effective acute treatment for migraine with non-inferior efficacy compared to current acute migraine therapies. Together with a very favorable safety profile, these findings suggest that REN may offer a promising alternative for the acute treatment of migraine and could be considered first line treatment in some patients.

Trial registration: ClinicalTrials.gov NCT03361423 . Registered 18 November 2017.

Keywords: Acute treatment; Conditioned pain modulation; Headache; Migraine; Neuromodulation; Non-pharmacological treatment; Remote electrical neuromodulation.

Conflict of interest statement

Alan Rapoport serves as an advisor for Amgen, Amneal, Automatic Technologies, Neurolief, Promius, Satsuma, Teva Pharmaceutical Industries, Theranica, and Zosano; and is on the speakers’ bureau of Amgen, Electrocore, Promius, and Teva Pharmaceutical Industries, Jo Bonner declares no competing interests. Tamar Lin, Dagan Harris, Yaron Gruper and Alon Ironi are employees of Theranica Ltd. Robert Cowan serves as a consultant and/or on the Advisory Board for Alder, Allergan, Amgen, Biohaven, Electrocore, Impel, Lilly, Novartis, Satsuma, Supernus, Teva, Theranica, Xoc and Zosano; receives royalties from Penguin/Avery, Oxford University Press, and Springer; and is founder and principle in BonTriage, Inc. and ProMyHealth, LLC.

Figures

Fig. 1

Number of participants using different types of acute pharmacological treatments in their first reported attack in the run-in phase. AAC, aspirin, acetaminophen and caffeine; APAP, acetaminophen

Fig. 2

Efficacy comparison of pain responses in a single attack. a Pain relief at 2 h post-treatment of REN (solid black and diagonal black) compared with usual care (solid gray) and pharmacological treatment (diagonal gray). b Pain-free at 2 h post-treatment of REN (solid black and diagonal black) compared with usual care (solid gray) and pharmacological treatment (diagonal gray). *p < 0.05

Fig. 3

Efficacy comparison of pain responses in at least 1 of 2 attacks. a Pain relief at 2 h post-treatment in at least 1 of 2 attacks following REN treatment (solid black and diagonal black) compared with responses usual care (solid gray) and pharmacological treatment (diagonal gray). b Pain-free at 2 h post-treatment in at least 1 of 2 attacks following REN treatment (solid black and diagonal black) compared with usual care (solid gray) and pharmacological treatment (diagonal gray). *p < 0.05