HPR Dr. Schaffler GmbH conducts Phase-I clinical studies in CNS – focused on experimental (CNS) pharmacodynamics and pain processing in humans.

Economic aspects of phase-I clinical trials:

HPR Dr. Schaffler GmbH studies are run economically and time-saving by the use of advanced computer-assisted, on-line procedures and by the use of relatively low sample sizes in trial conduct (e.g. n=18 to 24 subjects), as well as by the introduction of ethically acceptable intra-individual crossover designs, in which each participant is his/her own control (resulting in a low variability for a complex and efficient repeated-measurement statistic with baseline adjustment).

Phase-I Clinical Trials (CNS and Pain)

HPR Dr. Schaffler GmbH offers study designs in the following areas:

  • Pharmacodynamics (pd) / Pharmacokinetics (pk)
  • Bioequivalence / Bioavailability (pk and pd)
  • Safety checks (basic and every-day-related testing of tolerance – e.g. as diverse vital sign and laboratory parameter measurements, as well as testing car driving ability, handling machinery and investigations of drug/drug and drug/alcohol interactions)
  • Efficacy pd-testing of vigilance, cognition, psycho- and skeleto-motor testing, tremor, hypoxia, hypercarbia, quantitative (Laser) algesimetry, induction and measurement of inflammatory processes
  • Time-efficacy and dose-response
  • Interactions: Drug-drug, drug-food (pk) and drug-alcohol pd-interactions (i.v./ parenteral alcohol model) – as well as general pk/pd testing
  • Proof of Concept (PoC)/ Proof of Principle (PoP)/ Proof of Mechanisms (PoM) studies

Studies are designed by incorporating the following models and methods:

  • Investigation of multiple types of Evoked Potentials (EPs) from scalp EEG (AEP, SEP, VEP)
  • Standard and/or provocation EEG: e.g. resting, vigilance-controlled, and task-related EEG or EEG under additional provocations like photic driving, hyperventilation and sleep deprivation conditions
  • Electroretinography (ERG) – as a special case of EPs at the eye – resulting from retinal responses to light stimuli (peripheral glia cell approach via b-wave effects!) with the option of simultaneous, occipital VEP evaluation
  • Oculodynamic test (ODT) – saccadic eye movement measurements (EOG) – with the simultaneous application of a combined complex choice reaction task (CRT)
  • Pursuit tracking test (PTT) – eye-hand-coordination test (visu-motoric task)
  • Questionnaires including computer-assisted data capture
  • Computerized visual analogue scales (VAS scoring on tablet PC)
  • Orthostatic strain/dysregulation test (tilt-table)
  • Integrated force/EMG-measurement system
  • Tremor intensity measuring (by tremor spectral analysis – measuring tremor amplitude and frequency)
  • Skin colour measurement, using CIE Lab-system with red-green and blue-yellow colour dimension or single colour spectra (SRS, skin reflection spectrometry)
  • pd-modeling
    • Laser-pain model/quantitative algesimetry
    • UV and capsaicin application for inflammatory and sensitized skin state induction (e.g. hyperalgesia, allodynia)
    • hypoxia model (normobaric exposure to 10% oxygen/global cerebral deficit syndrome induction)
    • respiratory depression testing (drug-induced) with CO2-application (exposure to increasing inspiratory CO2 concentrations of 0%, 2% and 4%, hypercarbia)
    • “motion sickness” simulation by caloric stimulation of inner ear – measuring of induction and changes in nystagm, sweating and vital signs