ESPOUSE study of SpringTMS in migraine meets primary endpoint- eNeura

eNeura announced positive topline data from its ESPOUSE (eNeura SpringTMS Post-market Observational U.S. Study of Migraine) Study. The study achieved its primary endpoint showing reduction in monthly headache days. eNeura plans to submit the positive data to the FDA to expand the SpringTMS label to include migraine prevention. The ESPOUSE Study was conducted at eight leading U.S. Headache Centers on 132 migraine patients. Patients following a protocol of daily use of the SpringTMS device reported an average reduction from nine headache days per month at baseline to six days post treatment. There were no serious adverse events reported during the study.

The data is consistent with a post-market study published in the UK that supported the company's expansion of the CE Marking label for its SpringTMS device to include migraine prevention in addition to acute treatment of migraine. Of the 190 patients surveyed in the study (59 with episodic and 131 with chronic migraine), 62% reported pain relief, indicating that the device was effective at reducing or alleviating migraine pain. Patients with episodic migraine saw a reduction from a baseline of 12 days per month to nine days and patients with chronic migraine saw a reduction from 24 days baseline to 16 days. Patients also reported a reduction in headache duration, pain severity and medication use. There were no serious adverse events reported during this study as well. Topline data was presented at the European Headache and Migraine Trust International Congress (EHMTIC).