Abstract
BackgroundThere 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.MethodsWe 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.ResultsOf 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.ConclusionREN 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 registrationClinicalTrials.gov NCT03361423. Registered 18 November 2017.
Highlights
Migraine is one of the most prevalent and disabling neurologic diseases [1], characterized by recurrent, often disabling, headache attacks associated with nausea, vomiting, photophobia, and phonophobia [2]
Migraine attacks are frequently treated symptomatically with nonsteroidal anti-inflammatory drugs (NSAIDs), simple analgesics such as acetaminophen or aspirin, at times combined with caffeine, or with specific migraine treatments such as triptans and ergots [3]; these pharmacological treatments may be ineffective, poorly tolerated, contraindicated, and if used to excess, may lead to medication overuse headache [4, 5], migraine chronification [6] and significant medical complications
The characteristics of the first treated attack in the run-in phase were similar to those of the test treatment with active remote electrical neuromodulation (REN), except for nausea which was more frequently reported in the test treatment compared to the first attack treated with usual care (p = 0.035)
Summary
Migraine is one of the most prevalent and disabling neurologic diseases [1], characterized by recurrent, often disabling, headache attacks associated with nausea, vomiting, photophobia, and phonophobia [2]. There is a significant unmet need for new, effective and well tolerated non-pharmacological acute migraine therapies. A recent randomized, doubleblind, sham-controlled, multicenter study has demonstrated that REN provides superior, clinically meaningful relief of migraine pain and complete pain freedom at 2 h post-treatment compared to sham stimulation. This study demonstrated a low incidence of device-related adverse events which was similar between treatment groups (4.8% vs 2.4%, p = 0.49). 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 compare the efficacy of REN with current standard of care in the acute treatments of migraine
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