Two different clinical trials have been conducted within the realm of the QSPainRelief project – extending, in part, beyond the end of the project: The first one on healthy volunteers, the second one on patients suffering from persistent pain after surgery, also called persistent post-surgical pain (PPSP).
Trial 1 – Healthy volunteers
Contact:
Prof. Dr. Geert Jan Groeneveld
CSO and CMO at CHDR
+31 715 246 407
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In the first clinical trial on 48 healthy volunteers, 2 novel combinations of pain medication (opioid + A, and opioid + B) were compared to placebo treatment to assess their clinical efficacy, safety, tolerability, and pharmacokinetic parameters. The novel analgesic combinations in these studies consisted of a selected opioid with known analgesic effects in both acute and chronic pain conditions, and a novel compound A or compound B, respectively. Which opioid was used was determined by work package 2 (WP2) researchers during the project. The nature of compounds A and B were determined through mathematical modelling of work package 4 (WP4) experts. This ensured that the most promising compounds with the best analgesic profile were chosen.
Both studies (opioid + A, and opioid + B) investigated the clinical efficacy and potential adverse effects in 24 healthy women and 24 healthy men (aged 18 to 45) compared to each of the two analgesic compounds alone and compared to placebo treatment. The two studies were organised by the Centre for Human Drug Research (CHDR) in Leiden, the Netherlands, as part of work package 7 (WP7).
Trial 2 – Chronic pain patients
Contact:
Prof. Dr. Patricia Lavand’homme
Professor of Anaesthesiology
Phone: +32 276 418 97
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OR
Prof. Dr. André Mouraux
Professor of Medicine
Phone: +32 276 454 47
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The second clinical trial on up to 180 patients suffering from persistent post-surgical pain (PPSP) aimed for improved pain relief in these patients and assessed the actual therapeutic effect of different combinations of pain medication. The real-world data collected in this trial has been and will continue to be essential for calibrating and fine-tuning the QSPainRelief platform, so that in the near future (when the QSPainRelief platform will be ready and openly accessible for medical professionals), the best possible combinational treatment strategy can be selected for each chronic pain patient, based on their age, sex, genetic background and medical history.
- Calibration of the QSPainRelief platform required patient data from about 60 individuals on how different drug combinations affect the processing of nociceptive (pain-sensing) input in the spinal cord and brain, in other words, how they affect the central nervous system (CNS) regarding medication-induced therapeutic versus adverse effects, and how these effects within pain-relevant neuronal networks of the CNS translate into what the patient feels and how effective the treatment is.
- Following this calibration step, additional patient data from about 120 individuals are required to evaluate the ability of the QSPainRelief model platform to prospectively predict CNS effects and clinical effects of different treatment combinations in patients. This step is still ongoing beyond the end of the project.
To that end, work package 8 (WP8) researchers are currently still conducting a clinical study in both female and male patients (age 18 to 70) who suffer from disabling post-surgical pain for more than two weeks after surgery to characterise the treatment effects of different drug combinations and two common adverse effects, namely sedation and cognitive dysfunction. Using non-invasive biomarkers of CNS activity, such as electroencephalogram (EEG) data, measurable CNS effects within pain-relevant neuronal networks are being compared with the clinical therapeutic effects and any adverse effects self-reported by the patients. These self-reports, collected up to three months after treatment initiation, are also intended to monitor potential pain medication misuse or addictive behaviour. Patients are recruited at Cliniques Universitaires Saint-Luc (CUSL) in Bruxelles, Belgium, and tested at Université Catholique de Louvain (UCL) in Louvain-la-Neuve, Belgium. View this brief video explaining the online patient questionnaire!
Data protection & privacy
Processing of patient data for research within QSPainRelief and beyond the end of the project underlies strict ethics guidelines for data protection. Therefore, patient data will only be used after explicit written agreement by each patient and in an untraceable, anonymised way.