IntraBio Authorized to Begin Phase III Trial for CACNA1A-Related Disorders
IntraBio Inc. has received regulatory authorization to commence a pivotal Phase III trial of levacetylleucine for CACNA1A-related disorders across the U.S., U.K., EU, and Switzerland. The trial will involve 12 multinational sites and will use a 12-week, randomized, double-blind, placebo-controlled crossover design. This study aims to evaluate the safety, tolerability, and efficacy of levacetylleucine, a drug previously approved for Niemann-Pick disease type C. CACNA1A-related disorders are rare neurological conditions with no current approved therapies. The trial's design mirrors successful previous studies, potentially offering a new treatment option for affected patients. 
