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Tools4Patient presented data at the MDS Congress 2021 that predicted the placebo response in Parkinson's disease (PD) in a multi-center, multi-national clinical study. This approach–called Placebell©™–to mitigate the negative impact of the placebo response is an effective tool to increase study power of randomized clinical trials (RCTs), resulting in increased success rates and decreased clinical trial timelines and cost.
The predictive, multivariate Placebell model is based on patients' psychological traits and other factors associated with the placebo response (e.g., baseline PD intensity). For this study, 94 subjects with mild to moderate PD received placebo treatment for 3 months in a blinded administration. The placebo response was measured by: MDS-UPDRS part III (primary endpoint); MDS-UPDRS part I, II and IV; IGAC, PGAC; PDQ-39 (PD questionnaire); ESS (Epworth Sleep Scale); FSS (Fatigue Severity Scale). Tools4Patient's proprietary Multidimensional Psychological Questionnaire (MPsQ) was administered once (at baseline) and was used to assess various psychological traits related to the placebo response.
Read more about the presentation and model here.