Tools4Patient Develops Predictive Model of the Placebo Response in Parkinson’s Disease
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.
“Modeling the Placebo Response in Parkinson’s Disease” was 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); Olivier Rascol (Centre d’Investigation Clinique, INSERM); Gaetan Garraux (University of Liege); Brian Berman (Department of Neurology; VCU School of Medicine); Glenn Stebbins and Christopher Goetz (Department of Neurological Sciences; Rush University Medical Center).
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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.
The placebo response is a major contributing factor to clinical trial failures (even late-stage) in many therapeutic areas. Tool4Patient’s Placebell is an innovative predictive method that addresses this complex challenge. Placebell combines machine learning-based algorithms with individual patient personality data to predict the individual placebo response in a patient before the first dose of a drug is administered. This predictive tool improves the success rate of clinical trials, all with no statistical or operational risk to a study. These data in PD further the positive results with Placebell in osteoarthritis, demonstrating consistent and repeated reduction in data variability and improvement in clinical trial assay sensitivity.
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“The placebo response is a significant barrier to demonstrating efficacy of experimental therapies for Parkinson’s disease,” says Olivier Rascol, M.D., Ph.D. Professor of Clinical Pharmacology at Toulouse University Hospital, France. “This predictive model of the placebo response in Parkinson’s disease is an important step forward in managing this issue and accelerating the delivery of medicines to this patient population.”
“The Parkinson’s disease study extends Placebell’s success as a platform solution for multiple indications, including recent data analyzed for chronic pain, OA and ophthalmology,” says Dominique Demolle, Ph.D., CEO of Tools4Patient. “We continue to partner with top pharma and biotech companies – along with top CROs – to help reduce drug development risk related to the placebo response using Placebell. This is part of a portfolio of solutions being developed by Tools4Patient that address key challenges to drug development.”
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