Prescription digital therapeutics company, Click Therapeutics, has announced the initiation of a fully remote and decentralised pivotal trial. The study, entitled ReMMi-D, Reduction in Monthly Migraine Days will investigate the efficacy and safety of prescription digital therapeutics in reducing the number of monthly migraines for adults diagnosed with episodic migraine.
Unlike traditional clinical trials, ReMMi-D is a completely remote study, where patients receive digital therapy through a mobile app with study participants remaining in their usual setting. This will allow for a more representative population for enrollment, as patients do not need to travel to a designated clinical trial site.
The fully decentralised Phase 3, randomised, double-blind trial will enrol approximately 558 patients in the U.S. The intervention will be delivered over 12 weeks and efficacy will be evaluated as a change from the baseline in the number of monthly migraine days, between the groups.
“We are pleased and excited to have launched a pivotal trial to validate new ways of helping patients with migraine,” said Shaheen Lakhan, MD, PhD, FAAN, Chief Medical Officer of Click Therapeutics. “We are hoping to support not only the 40 million people with migraine, but also the extensive network of primary care providers and fellow neurologists who are at the forefront battling this disease.”
Click here to read the original news story