The effects of pain killers on pain processing - fMRI (version 1.0)
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled, cross-over trial in healthy subjects to investigate the effects of lacosamide, pregabalin and tapentadol on biomarkers of pain processing observed by functional magnetic resonance imaging (FMRI) of the brain
IRAS ID
264792
Contact name
Irene Tracey
Contact email
Sponsor organisation
Danish Pain Research Centre, Department of Clinical Medicine, Aarhus University, Denmark
Clinicaltrials.gov Identifier
2019-000908-15, EudraCT number
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
This is an fMRI study in healthy volunteers to investigate how the body reacts to three different types of standard-of-care pain killers, namely Lacosamide (Vimpat ®), Tapentadol (Palexia ®) and Pregabaline (Lyrica ®). The results may help to develop better pain treatment in the future.
Currently available pharmacological therapies provide inadequate relief for many patients with chronic pain. It is known that novel drugs which are efficacious analgesics in preclinical models often have little or no clinical efficacy, but it is often not known whether the drug engaged the human target sufficiently to have a meaningful pharmacodynamic effect. Hence, early deselection of unpromising candidates would greatly reduce attrition rates in clinical development. The drugs used in this study are standard-of-care pain killers. By validating the effects of these drugs on pain hypersensitivity, and measuring changes in brain activity due to the drugs, we aim to develop a set of objective measures of nociceptive signal processing and functional biomarkers derived from non-invasive fMRI measures of brain activity. This will facilitate novel drug development in the future.
A multisite, exploratory, single dose, randomised, placebo-controlled, double-blinded, crossover design will be used. We aim to recruit 20 healthy volunteers aged 18-45, each of whom will complete 5 visits to the Centre for Functional MRI of the Brain (FMRIB) at the John Radcliffe Hospital, Oxford. Visit 1 will involve eligibility assessment, demonstration of the test stimuli (induce sensitisation on the left leg using High Frequency Stimulation routinely used for clinical diagnostic purposes) and baseline fMRI measures. During visit 2-5, we will measure the effects of the three drugs on this hypersensitivity and the associated changes in brain activity using functional MRI. This will be compared to the effects of placebo. The study is a part of the IMI2-Paincare project (www.imi-paincare.eu).
REC name
South West - Central Bristol Research Ethics Committee
REC reference
20/SW/0017
Date of REC Opinion
19 Mar 2020
REC opinion
Further Information Favourable Opinion