Theranica Bio-electronics, a prescribed digital therapeutics company developing advanced digitally connected neuromodulation devices for migraine and other pain conditions, announced positive top-line results in its double-blind, randomized, placebo-controlled, multi-center, pivotal clinical trial in the USA (NCT04828707). This trial evaluated the efficacy and safety of Nerivio® for the preventive treatment of migraine in both episodic and chronic migraine patients. The study met the primary endpoint, demonstrating a statistically significant reduction from baseline in monthly migraine days in patients treated with Nerivio®, compared with a placebo device.
Subjects who used Nerivio® every other day experienced a reduction of 4.0 migraine days per month from baseline, compared to a reduction of 1.3 days in the placebo group (net therapeutic gain of 2.7 days, p<0.0001). The study further analyzed the reduction of monthly migraine days separately for chronic migraine participants, who experienced a reduction of 4.7 days (placebo: 1.6 days, p=0.001); and episodic migraine patients, who experienced a reduction of 3.2 days (placebo: 1.0 days, p=0.003).
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