Translational pain models in humans
The objectives of this work package are:
- To improve the design, construct and predictive validities of experimental pain models in healthy human subjects.
- To link sensory profiles and biomarkers in human pain models to known mechanisms in animal pain models.
- To provide links between animal pain models and clinical pain states.
- To improve human pain modeling by reference to the IMMPACT domains for clinical trials (e.g. measurement of spontaneous and evoked pain and pain co-morbidities such as anxiety, circadian rhythm disturbance and cognitive impairment).
- To compare electrophysiologically recorded changes in peripheral nerve activity (microneurography and non-invasive measures of excitability) in human and animal models.
- To provide materials for a training center for teaching human surrogate models.
The development of human models and markers to translate pain outcomes and pharmacology between animals and humans consists of three parts:
- Part 1: Refinement of human surrogate models.
- Part 2: Refinement of end points in human pain models that can serve as a translational comparator for animal data and chronic pain patients.
- Part 3: Consensus conference to compile and compare findings on models, readouts, pharmacological interventions with drugs and trial designs.
Based on the multidimensional data set which will be derived from part 1 and 2, the consensus conferences will address the design of future multi-center proof of concept trials, potentially using several models, several readouts and several pharmacological interventions. This comprehensive data compilation and discussion will result in a recommendation for a battery of human translational models for pharmacodynamic profiling of new analgesics.
Participants contributing to Work Package 3:
- Ruprecht-Karls-Universität Heidelberg (lead)
- Grünenthal GmbH (co-lead)
- King’s College London
- Neuroscience Technologies S L
- Christian-Albrechts-Universität zuKiel
- Klinikum der Johann Wolfgang Goethe-Universität Frankfurt amMain
- Boehringer Ingelheim International GmbH
- Pfizer Ltd
- Eli Lilly and Company Ltd
- UCB Pharma SA
- Laboratoriosdel Dr Esteve S A,
- AbbVie GmbH & Co KG