ObvioHealth and Mi-Helper, Inc. announce a partnership to conduct a decentralized clinical trial for a non-invasive neuromodulation device for the treatment of migraines. The randomized controlled trial will be fully remote, enabling data capture from home—where the device is intended to be used.
Mi-Helper has been developed to meet a massive unmet need for effective, targeted, and drug-free pain management of migraines, a condition which impacts 1 billion people worldwide. Severe headaches are among the top causes of emergency room outpatient visits in the United States. And, in a recent study, 40% of migraine sufferers reported dissatisfaction with current treatments due to lack of efficacy, poor tolerability, and contraindications to common migraine-specific medications.
The small Mi-Helper device delivers a controlled stream of conditioned air with a nebulized mist to the mucosa membranes in the nose, providing relief from migraine-related pain and associated symptoms such as nausea and photosensitivity.
“We are working with the top headache neurologists in the world to inform our clinical studies,” said Steve Schaefer, CEO of Mi-Helper. “We are committed to delivering a paradigm shift for migraine treatment—fast, accessible, and affordable relief for this highly complex and debilitating neurological disease.”
The Mi-Helper study features an adaptive design, beginning with the establishment of optimal dosing and culminating in a pivotal trial to determine therapeutic efficacy. The ObvioGo app will enable patients to remotely enroll, consent, and report relief of pain and other migraine symptoms as well as the use of rescue medications and any potential adverse events. ObvioHealth’s COACH (Clinical Oversight And Coordination Hub) team will remotely monitor patient compliance and safety in near real time.
“Mi-Helper and ObvioHealth are dedicated to inclusivity,” said Ivan Jarry, CEO of ObvioHealth. “By designing a decentralized clinical trial without the need for physical site visits, we can recruit patients anywhere in the continental United States, including underserved communities. This will provide Mi-Helper with essential data on a real-world population in a real-world setting and should help to ensure that the device, when launched, can serve a broad population.”
SOURCE: PR Newswire