ObvioHealth and Mi-Helper have announced a partnership to conduct a decentralised clinical trial with a small, non-invasive neuromodulation device for the treatment of migraines. The randomised controlled trial will be fully remote, enabling data capture from home—the setting in which the device is intended to be used.
The Mi-Helper device delivers a controlled stream of conditioned air with a nebulised 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, as per an ObvioHealth press release. The ObvioGo app will enable patients to remotely enrol, consent and report relief of pain, and other migraine symptoms, as well as the use of rescue medications and any potential adverse events. The release adds that 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 decentralised clinical trial without the need for physical site visits, we can recruit patients anywhere in the continental USA, 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.”
This study is expected to begin recruiting in the summer of 2023.