Ensuring Endpoint Reliability in Movement Disorder Trials

Case Study Optimizing Clinician Ratings in a Tardive Dyskinesia Trial

Signant's Rater Training and Central Rating services played a key role optimizing signal detection for a movement disorder trial that led to FDA product approval.

This regulatory efficacy trial assessed abnormal, involuntary movements in patients with tardive dyskinesia using the Abnormal Involuntary Movement Scale (AIMS).

Our comprehensive approach helped investigators deliver consistent, standardized assessments by:

• Training and calibrating raters to ensure accurate, consistent COA administration and scoring
• Conducting site-independent, blinded ratings to assess changes in AIMS scores with maximum precision
• Implementing quality monitoring throughout the study to identify and address potential scoring variability

The successful outcome of this study directly contributed to FDA approval of a novel treatment for tardive dyskinesia.