Theranica has announced the publication of a new, peer-reviewed article in Pain Reports detailing a study assessing its novel, drug-free treatment option for chronic migraine. The prospective, multicentre, open-label trial evaluated the efficacy and safety of remote electrical neuromodulation (REN), provided using the company’s flagship product, Nerivio—a smartphone-controlled, prescribed wearable device for the acute treatment of migraine in chronic migraine patients.
Results from the study’s 99 chronic migraine participants demonstrated favourable efficacy of REN, with nearly 60% of the participants experiencing pain relief at two hours after the treatment and close to 65% of those experiencing sustained pain relief even 24 hours post-treatment. More than 20% of the participants experienced disappearance of their headache (pain freedom) at two hours post-treatment as well.
Additionally, post two-hour improvement in nausea, photophobia, phonophobia and functional ability were demonstrated. Only one of the 99 participants (1%) reported a mild, local device-related adverse event—which was resolved independently shortly after the treatment, according to a Theranica press release.
“Chronic migraine is characterised by headaches experienced on at least 15 days per month,” said Brian Grosberg, director of the Hartford Healthcare Headache Center (West Hartford, USA), who served as the primary investigator of the study. “People with chronic migraine not only have a higher frequency of migraine attacks, but their attacks tend to be more severe than episodic migraine patients. They typically need to take more medications, usually cocktails of preventive and acute medications. The challenge is to relieve the migraine symptoms while avoiding the risk of medication overuse headache (MOH) and other complications. Non-pharmacological interventions such as REN help meet this need by providing a drug-free treatment option. As a clinically validated, non-pharmacological acute treatment option for people with migraine, Nerivio is an excellent fit for fulfilling this need.”
“To the best of our knowledge, this was the largest clinical trial of acute treatment of migraine specifically targeting chronic migraine patients,” said Liron Rabany, chief scientist of Theranica and a co-author of the study paper. “We are determined to continue our clinical development, adding ever-increasing solid evidence of the clinical benefit that REN brings to different sub-populations of people with migraine. All people with migraine, adults or adolescents, should have the option of discussing a non-pharmacological therapy with their healthcare providers, as a first-line treatment option, or as an adjunct.”
Worn on the upper arm at the onset of a migraine attack, Nerivio alleviates migraine symptoms without need for medications by utilising REN to trigger an endogenous analgesic mechanism, known as conditioned pain modulation (CPM). The device is controlled by an app on the patient’s smartphone, allowing patients to set the intensity of their treatment.
Nerivio has received US Food and Drug Administration (FDA) authorisation and a CE mark for use in acute treatment of episodic and chronic migraine in adult and adolescent patients, and, the release adds, already serves close to 25,000 people with migraine in the USA.