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Tools4Patient has 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.
FREMONT, CA: Tools4Patient, a pioneer in the healthcare industry, aims to accelerate patients' lives by developing and commercializing methods and dada analysis solutions focused on the unique patient behaviors that influence their response to treatment.
Tools4Patient has 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 method of mitigating the negative impact of the placebo response, known as PlacebellTM, is an effective tool for increasing study power in randomized clinical trials (RCTs), resulting in higher success rates and shorter clinical trial timelines and costs.
"Modeling the Placebo Response in Parkinson's Disease" has been presented at the International Parkinson and Movement Disorders Society's MDS Congress 2021. Co-authors of this study include Samuel Branders, Celine Billocq and Alvaro Pereira (Tools4Patient); Gaetan Garraux (University of Liege); Brian Berman (Department of Neurology; VCU School of Medicine); Olivier Rascol (Centre d'Investigation Clinique, INSERM); Glenn Stebbins and Christopher Goetz (Department of Neurological Sciences; Rush University Medical Center).
Tools4Patient's Parkinson's disease study takes Placebell's success as a platform solution for multiple indications to the next level.
The predictive, multivariate Placebell model is based on patients' psychological traits and other factors related to the placebo response (e.g., baseline PD intensity). For this study, 94 subjects with mild to moderate PD received placebo treatment for three 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 utilized to assess various psychological traits related to the placebo response.
In many therapeutic areas, the placebo response is a major contributor to clinical trial failures (even late-stage failures). Placebell by Tool4Patient is an innovative predictive method that addresses this complex challenge. Placebell predicts the individual placebo response in a patient before the first dose of a drug is administered by combining machine learning-based algorithms with individual patient personality data. This predictive tool improves clinical trial success rates while posing no statistical or operational risk to the study. These findings in Parkinson's disease add to the positive results obtained with Placebell in osteoarthritis, demonstrating a consistent and repeated reduction in data variability as well as an improvement in clinical trial assay sensitivity.