Cefaly in Hot Pursuit of a Migraine Prevention Indication

Each year migraines are estimated to impact about 39 million people in the U.S. and about 1 billion worldwide. Chronic migraines are characterized by 15 or more headache days per month for at least three months.  Cefaly Technology has developed an electroceutical treatment platform that can tackle the neurological disease. However, the Belgium-based company is working on a new application for the Cefaly Prevent Device to focus on the chronic migraine population. “When we received [FDA] approval for the device in 2014, it was mainly based on the trials that were executed for acutely migraine sufferer – so people that are suffering from two to eight migraine attacks per month,” Jean-Yves Mignolet, R&D manager for Cefaly Technology, told MD+DI. “To be able to extend the indication, we had to do a clinical trial addressing the chronic migraine sufferer.” Data from the study showed that the enrolled patients had an average 19 migraine days per month, which was significantly reduced by 23% after 3-months of electroceutical treatment with the Cefaly Prevent device. Other endpoints (headache episodes, headache days, cumulative hours of headache) were also significantly improved; very impressively, the consumption of anti-migraine medication was reduced by 31%. A sub-analysis was performed on a group of patients suffering from permanent headache, which is the most difficult category of migraine patients to treat, yet even in this category patients showed significant imp...
Source: MDDI - Category: Medical Devices Authors: Tags: Electronics Source Type: news