Unified Dyskinesia Rating Scale: Application for FDA Designation as a Preferred Scale for Assessing Dyskinesia in Parkinson’s Disease

Study Rationale:
Several scales are available for the rating of dyskinesia in Parkinson’s disease, and the designation of a single preferred scale for studies of  new treatments will allow different treatments to be compared in a uniform manner with a single measurement tool that best fits the needed criteria to asses all aspects of dyskinesia.

Hypothesis:
Given the strong clinimetric profile of the Unified Dyskinesia Rating Scale (UDysRS) and its core features of reliability, validity, responsivity and availability in several languages, we hypothesize that the FDA will accept the UDysRS as a preferred scale.

Study Design:
The investigators will develop an application to the FDA that documents the clinimetric strengths of the UDysRS with documentation on its wide use and scientific rigor.

Impact on Diagnosis/Treatment of Parkinson’s Disease:  
Having a single designated scale for the evaluation of all treatments being developed for dyskinesia in Parkinson’s disease will allow a uniform and carefully synchronized comparison of interventions so that treatments can be compared and the superior treatment can be readily identified for patients.

Next Steps for Development:  
Working with The Michael J. Fox Foundation (MJFF), the PIs will develop the application and submit it promptly within the granting period with a request for rapid review and designation. If successful, the PIs will work with MJFF and the International Parkinson and Movement Disorder Society to publicize the designation worldwide.