Efficacy and Safety of Gemlapodect in Adults & Adolescents with Tourette Syndrome

A double-blind, placebo-controlled, phase 2b, multi-center, twelve-week prospective study to evaluate the efficacy and safety of gemlapodect in Adult and Adolescent Patients with Tourette Syndrome. The study aims to determine whether the investigational drug, gemlapodect, can reduce tics in individuals with Tourette’s Syndrome.

As a site coordinator I managed the daily operations at Cortica from study startup, designing source documents, and developing standardized practices, to recruitment, scheduling, running visits, and data management. Throughout, I maintained continuous dialogue with the study sponsor, principal investigator, site staff, and participants, while ensuring compliance with confidentiality agreements, Good Clinical Practices, and both FDA and IRB regulations.