We are happy to announce the start of the second AGI Studio series on placebo effects in ataxias.
PLACEBO EFFECT: how to infer it, and how to accommodate it in ataxia trial designs?
While planning of current and upcoming ataxia treatment trials does need to account for placebo effects, in order to ensure that the trial will be a success, there is a stark absence of data allowing to calculate the placebo effect in ataxia trials. This AGI studio aims to provide a joint discussion format on how to infer the placebo effect in ataxia treatment trials, and how to accommodate it in ataxia trial designs. The presentations aim to kick off and structure this discussion format by several inputs:
• an overview on the placebo effect in ataxia treatment trials, potential mechanisms, and learnings from other diseases (session #1)
• learnings from the placebo response in FA, including discussions on which items are more vs less prone to placebo- and which might at least partly generalizable even across ataxia genotypes (session #2)
• modelling the placebo response in ataxia trials (session #3)
AGI studios are not “ready-to-digest presentations”, but instead aim to provide an active, joint open discussion format for hard-to-crack methodological key bottlenecks in the ataxia trial-readiness field, where potential first approaches towards solutions are to be developed jointly by all attendees (rather than ready-made by the presenter and/or moderator).
Register now for our studio sessions:
Session #1. The placebo effect in ataxia trials: overview, potential mechanisms, and learnings from other diseases.
Date: Fr, 19 May 2023, 4-5 PM CEST
Speakers:
Roderick Maas (Radboud University Medical Center, the Netherlands)
Annette Merdes/Veronique Crutel (Servier)
Register here
Session #2: Experiences from Friedreich's Ataxia: The Placebo Effect in Clinical Trials using the mFARS Scale
Date: 2 June 2023, 4-5 pm CEST
Speaker: Christian Rummey
Register here
Session #3: Modelling the placebo response in ataxia trials.
Date: 16 June 2023, 4-5 pm CEST
Speaker: Sophie Tezenas du Montcel (Sorbonne University, Paris, France)
Register here
Past Studios:
Studio 1 (July 2022): Longitudinal progression modelling of COAs in ataxia – differential value vs. limitations of change models, slope models, and disease course mapping, exemplified for degenerative ataxias.
Hosts: Matthis Synofzik & Andreas Traschütz (AGI Working Group 1)
Each session presented a different perspective and discussion on longitudinal progression modelling of COAs in ataxia, in particular the models and methods to be used.
Session 1
Speaker: Christian Rummey (Clinical Data Science GmbH, Basel, Switzerland)
past event
Watch the video here
Session 2
Speaker: Dieter Hilgers (University of Aachen, Aachen, Germany)
past event
Watch the video here
Session 3
Speaker: Sophie Tezenas du Montcel (Sorbonne University, Paris, France)
past event
Watch the video here