ML-004 in Adolescents and Adults with Autism Spectrum Disorders (ASD)
A randomized, double-blind, parallel group, placebo-controlled study to investigate the efficacy, safety and tolerability of ML-004 in adolescents and adults with ASD. The study aims to understand whether ML-004, an extended-release version of zolmitriptan, can support with emotion regulation and sociability in those with Autism Spectrum Disorder.
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.
Visits consisted of completing a range of rating scales, assessments, and medical procedures administered by the PI and/or the site coordinator. To successfully run visits I was trained in administering the Wechsler Abbreviated Scale of Intelligence (WASI-II), Tobii eye-tracking software, and deemed research reliable in conducting the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2). My visit responsibilities also consisted of managing appointment structures, recording vitals, performing ECGs, and answering any procedure or protocol related questions.