Efficient remote electrical neuromodulation device for migraine prevention in pivotal trial

Efficient remote electrical neuromodulation device for migraine prevention in pivotal trial

Efficient remote electrical neuromodulation device for migraine prevention in pivotal trial

in adults with both episodic and chronic migraine Headache, the remote electronic neuromodulation (REN) device Nerivio (Theranica) demonstrated superiority over a placebo device in reducing monthly migraine days when used for preventive treatment.

According to Theranica, the pivotal double blind, randomized placebo-controlled clinical trial met its primary endpoint, indicating that there is a history of at least 6 months in patients with migraine. headacheTreatment with Nervio resulted in a reduction of 1.3 days in the placebo group (net therapeutic benefit, 2.7 days; P<.001).

When investigators examined Chronic and . evaluated the effect of Nervio on separate monthly migraine days for patients with episodic migraineA reduction of 4.7 days was reported compared to 1.6 days for placebo in the past (P = .001) and a reduction of 3.2 days later, compared to 1.0 days for placebo (P = .003).

“These data demonstrate Nervio’s potential to provide a new non-pharmacological preventive treatment option for people with migraines,” said primary investigator Brian Grosberg, director of the Hartford Healthcare headache program in Connecticut. a statement. “The higher efficacy of Nerivio compared to placebo, along with favorable safety and tolerability, suggests that REN may be a beneficial non-pharmacological therapy option for both preventive and acute treatment of migraine, subject to FDA approval. “

The 248 study participants, aged 18 to 75 years, had a history of 6 to 24 headache days per 28-day period for each of the 3 months preceding the study. They were allowed to continue urinating 1 drug with potential migraine-prophylactic effects. No patients were included who had an active implanted electrical and/or neurostimulator device, uncontrolled epilepsy, a history of opioid or barbiturate use, or who were pregnant or lactating.

A screening visit was followed by a 4-week baseline phase, an 8-week double-blind preventive treatment phase, and a 4-week open-label phase.

According to the study, 40% of the 248 study participants continued to use preventive medications, primarily prescribed oral medications, calcitonin gene-related peptide monoclonal antibody injections, and onabotulinumtoxinA injections. Findings in patients in this subgroup were similar to those in the overall group, with Nervio treatment having a reduction of 3.5 monthly migraine days compared to 1.5 days for the placebo device (P = .03).

An analysis of several additional endpoints also found Nervio to be better treated with placebo than with placebo, including:

  • Monthly average decrease All headache days from baseline: 4.5 days versus placebo 1.8 days p (P<.001)
  • decrease in monthly Moderate/severe headache days: 3.8 days versus 2.2 days; P =.005
  • mean lack On acute-drug days: 3.5 days versus 1.4 days; P = .001
  • percentage of patients Headache and moderate/severe headache experiencing a reduction in days

Theranica chief executive officer Alon Irony said evidence continues to accumulate from both randomized trials and real-world studies, either with non-pharmacological treatments or with drugs, for treating chronic pain diseases like migraines.

“It is well known that individuals with migraine have different responses to treatments, and sometimes respond best to a combination of different modalities.” He said the current study’s findings add to the increased support for developing migraine treatments beyond pharmaceuticals.

The company plans to submit details of the study to peer-reviewed publications and to present the data at future scientific conferences.

Reference: Grosberg B, Rabani L, Wiesel M, et al. AndEffectiveness comparison of remote electrical neuromodulation and standard care medications for the acute treatment of chronic migraine: a post-hoc analysis. Pain Manager. 2022;12:837-844. doi:10.2217/pmt-2022-0053.

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