Theranica announces positive results from clinical trial for migraine treatment device
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Theranica Bio-electronics announced positive top-line results from a double-blind, randomized, placebo-controlled, multicenter clinical trial to evaluate efficacy and safety of Nerivio for the treatment of episodic and chronic migraine.
According to a company release, the study met the primary endpoint, demonstrating a statistically significant reduction from baseline in monthly migraine days in patients treated with Nerivio — a smartphone-controlled, wearable device — compared with placebo.
“There is a growing recognition that certain chronic pain diseases, such as migraine, may be treated with therapies other than pharmacological agents, or in combination with those," Alon Ironi, CEO of Theranica, said in the release. “This is validated by clinical evidence from randomized controlled studies such as this one, as well as real-world evidence studies.”
Participants using Nerivio every other day experienced a reduction of 4 migraine days per month from baseline, compared with a reduction of 1.3 days in the placebo group, per the release. The study further showed that patients with chronic migraines experienced a reduction of 4.7 monthly migraine days, while those with episodic migraines experienced a reduction of 3.2 days.
In addition, Nerivio demonstrated superiority compared with placebo in mean reduction of monthly headache days (4.5 vs. 1.8), moderate/severe headache days (3.8 vs. 2.2), percentage of patients experiencing a reduction of headache days and moderate/severe headache days, and mean reduction of acute medication days (3.5 vs. 1.4), the release stated.
“The high efficacy of Nerivio compared to placebo, with favorable safety and tolerability, suggests that Remote Electrical Neuromodulation (REN) could be a beneficial nonpharmacological therapy option for both preventive and acute treatment of migraine, subject to FDA approval,” Brian Grosberg, MD, director of the Hartford Healthcare Headache Program in Connecticut and primary study investigator, said in the release.