HPR – Human Pharmacodynamics

30 Years Experience with Proof of Concept (PoC) Studies
in Human Pain Research – using
Human Pharmacodynamic (Laser) Algesimetry

Algesimetric measurements

using Laser-Evoked Potentials >LEPs< from different skin types (for INDs, Rx, generics, OTCs) in oral, parenteral & topical administration modes

EFNS guidelines (Europ J Neurol 2010) …  laser-evoked potentials (LEPs) are the easiest and most reliable of the neurophysiological methods for assessing function of nociceptive pathways …

The Approach

  • Multiple intra-individual cross-over designs
  • 2- up to 6-way crossover trial paradigms
  • With different skin conditions in the same trial

Time and Cost Aspects

  • Programmed saving with regard to both aspects
  • Full-service-testing of diverse nociceptive conditions – within one setting
  • Minor pool of participants (e.g. about 16 to 24 subjects only)

Study Conduct

  • Experimental part in well-defined time-lines
  • E.g. 6-way (single-dose) trial in 6 weeks + Screening and ESV period (of 1 week each)
  • 2 weeks for statistics and first results from up to 2300 LEP sessions per study
  • Realtime recording and pre-analysis during study

The Settings

  • Laser Evoked Potentials (LEPs) from normal and sensitized skin
    (e.g. UVB-irradiation and capsaicin-irritation)
  • Psychophysics, electronic (pain) VAS, QST & quantitative skin colorimetry
  • Use of healthy volunteers

Validity & Comparability

  • High – due to sophisticated (objective-quantitative) test paradigms and due to a high expertise with references to former studies in many other experimental and marketed analgesic compounds and similars – resulting in a large data base (>50 compounds), done with the same or similar settings for comparisons – over 30 years now


Invited Speaker at NIH Workshop:
Discovery and Validation of Biomarkers to Develop Non-Addictive Therapeutics for Pain

Emerging Tools and Approaches in Biomarker Discovery and Development

Predictive validity of human Laser-EPs in extended phase-I IND analgesic research

Look Video Cast of NIH Pain Workshop in Washington DC:
Link: https://videocast.nih.gov/summary.asp?Live=28514&bhcp=1

Start looking from 1:25h for presentation Day 2 Nov 15th 2018
(about 20min, Dr.K.Schaffler HPR – Discussion later)

Invited Speech at NIH Pain Workshop Washington DC Nov 15th 2018 (Video Cast)

Posted in Clinical Studies, Development/ Invention, Klinische Studien |

Important invitation by NIH to participate in “Discovery of Biomarkers to Develop Transformational Non-Addictive Therapeutics for Pain”

Posted in Clinical Studies, Development/ Invention |

A Phase I, randomized, double-blind, laser evoked potential study to evaluate the analgesic/anti-hyperalgesic effect of ASP9226, a state-dependent N-type voltage-gated calcium channel inhibitor, in healthy male subjects

Posted in Clinical Studies |

A Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase I Study of Analgesic/Antihyperalgesic Properties of ASP8477, a Fatty Acid Amide Hydrolase Inhibitor, in Healthy Female Subjects

Posted in Clinical Studies |

Investigation of the predictive validity of laser- EPs in normal, UVB-inflamed and capsaicin-irritated skin with four analgesic compounds in healthy volunteers

Posted in Clinical Studies |

HPR Poster Presentation at the 15th World Congress on Pain in Buenos Aires 2014

Posted in Clinical Studies |

HPR Dr. Schaffler GmbH in cooperation with Zalicus announces positive results of Z944 Phase 1B Clinical Study in Pain

Posted in Clinical Studies |

An oral TRPV1 antagonist attenuates laser radiant-heat-evoked potentials and pain ratings from UV(B)-inflamed and normal skin

Posted in Clinical Studies |

Dose-response relationship after single oral dose administrations of morphine and oxycodone using laser-evoked potentials on UVB- and capsaicin-irritated skin in healthy male subjects

Posted in Clinical Studies |

HPR Dr. Schaffler GmbH Corporate Video…

Posted in Clinical Studies |

American Society for Clinical Pharmacology and Therapeutics 2012 ASCPT Annual Meeting, March 12-17, 2012 in National Harbor, Maryland, US

Posted in Clinical Studies |

13th World Congress on Pain (IASP) in Montreal, Quebec, Canada, Aug./Sept. 2010

Posted in Clinical Studies |

7th Congress of the European Federation of IASP Chapters (EFIC) – PAIN IN EUROPE VII – Hamburg, Germany, September 2011

Posted in Clinical Studies |

Phase-I Pilot Study: Investigating objective measures of pain-processing-related nociception and subjective pain perception in an elderly cohort in the presence and absence of a standard analgesic on irritated (UVB) and non-irritated skin

Posted in Clinical Studies |