IMPACT-TD Registry: Real-World Assessment of the Impact and Progression of Tardive Dyskinesia

Abstract: Background: The long-term impact, burden, and treatment patterns of tardive dyskinesia (TD) are not well understood. Patient- and clinician-reported outcomes are important in determining the severity and multidimensional impact of TD on patients. This upcoming study will evaluate the course, impact, and treatment of TD in real-world clinical practice. Methods: This phase 4, prospective, observational, 3-year longitudinal study will consist of 2 parts. The study population in Part A (registry) will include adult patients who have probable TD. Part B (IMPACT-TD) will include a subset of patients in the registry who initiate TD treatment for the first time and will evaluate the impact of TD with 2 newly developed patient- and clinician-reported measures (adapted TD-specific Neuro-QoL and 4-domain clinical scale, respectively). Results: Recruitment is planned to start in the second half of 2022. Estimated sample size of the registry is a minimum of 600 patients in Part A with approximately 140 in Part B. The suggested clinic visit interval for Part A is approximately every 3 months for a total of 13 visits; for Part B, the interval is every month for a total of 4 visits. Conclusions: This upcoming study aims to assess the burden of TD and to educate on variables that affect the patterns and progression of TD. The 2 newly developed patient- and clinician-reported outcomes may be additional tools to assess the impact and treatment of TD.Short Description: The long-term assessment of patients with tardive dyskinesia (TD) is important in determining the severity and multidimensional impact of the disease. This upcoming phase 4, prospective, observational, 3-year longitudinal, 2-part study will assess the burden of TD with newly developed patient- and clinician-reported outcomes in real-world clinical practice.Name of Sponsoring Organization(s): Teva Branded Pharmaceutical Products R&D, Inc.