WP3 summary:

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)
  • AstraZeneca
  • King’s College London
  • UniversityofOxford
  • 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
  • Astellas