Results of largest study with a migraine device solidify safety, efficacy and tolerability of the drug-free Nerivio Migra, offering huge clinical benefit for migraineurs.
SCOTTSDALE, Arizona /PRNewswire/ -- At the annual headache symposium of the American Headache Society, Theranica, a biomedical technology company developing advanced electroceuticals for migraine and other idiopathic pain disorders, will announce the results of TCH-003, a pivotal study of the Nerivio Migra, a novel non-invasive neuromodulation device for the acute treatment of migraine.
"At least 36 million Americans suffer from migraines, at various degrees. Many patients are very dissatisfied with existing medication options (mainly NSAIDs and triptans) for acute treatment of migraine pain and accompanying symptoms, due to their side effects, minimal effectiveness and/or their potential for causing medication-overuse-headache," said Dr. Morris Levin, MD, Director of the Headache Center in the University of California in San Francisco, who served as the chairman of the independent Data Monitoring Committee of the study. "The Nerivio Migra is targeting a very significant unmet need in treating migraines, and the study results demonstrate the significant benefit that this treatment can bring to many patients. Conceivably, this device has the potential to lessen the inappropriate use of opioids and barbiturates for migraine pain, and perhaps other pain conditions."
The prospective, randomized, double-blind, sham-controlled, multi-center study evaluated the efficacy, safety and tolerability of the device on 252 patients who met the International Classification of Headache Disorders (ICHD-3) criteria of migraine with or without aura. The study met its primary and almost all of its secondary and exploratory results with high statistical significance. On its primary endpoint of pain relief at 2 hours post-treatment the device demonstrated 66.7% response rate in the active arm vs. 38.8% in the placebo (p<0.0001).
Statistical significance was obtained on 3 out of 4 secondary endpoints:
- On pain free at 2 hours post-treatment the response rate was 37.4% (active) vs. 18.4% (placebo) (p<0.004).
- On relief of the MBS (most bothersome symptom out of phonophobia, photophobia, and nausea) at 2 hours post-treatment the response rate was 46.3% (active) vs. 22.2% (placebo) (p<0.001).
- On relief of both pain and the MBS at 2 hours post-treatment the response rate was 40.0% (active) vs. 15.2% (placebo) (p<0.0005).
"The study endpoints cover all the main clinical benefits that are really important for patients," said Dr. Brian Grosberg, MD, Director of the Hartford Healthcare Headache Center in Connecticut, and the lead Principal Investigator of the study. "Statistical significance was obtained not only at post 2 hours, but also post 48 hours after the treatment, without any consumption of pain killers or migraine medications. We at the headache society, as well as our migraine patients throughout the nation have been waiting a long time for this - a drug-free acute treatment for migraine that really works well," added Grosberg.
Regulatory submission for Nerivio Migra has been filed in the United States.
Once approved, Theranica plans to commercialize Nerivio Migra by end of 2019.
Investigational Device -
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Ronen Jashek, VP marketing and Business development