Sensory Phenotyping to Enhance Neuropathic Pain Drug Development (SPENDD): A Randomized, Double-blinded Cross-over Clinical Trial Aimed at Investigating Whether Bedside Quantitative Sensory Testing Can Predict Response to Analgesics.
University of Rochester
Summary
The goal of this clinical trial is to determine whether quantitative sensory testing (QST) can be used to classify participants into pain sub-groups and predict who will respond best to certain pain treatments in participants with painful peripheral neuropathy. The analgesic effect is evaluated by measuring pain intensity and Patient Global Impression of Change (PGIC). This study is a 3-period cross-over trial. This means researchers will compare 3 different drugs (pregabalin, duloxetine, and placebo) over a period of 19 weeks. Participants will: * Undergo a quantitative sensory testing (QST) exam. * Provide a blood sample. * Complete questionnaires on the computer. * Take the study drug as instructed.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
5\. INCLUSION AND EXCLUSION CRITERIA Inclusion Criteria: Patients eligible for inclusion in this study must fulfill all of the following criteria: 1. Between 18 and 80 years old (inclusive). 2. Have a diagnosis of peripheral neuropathic pain in both feet from generalized distal sensory polyneuropathy based on the following criteria 1. A history of a relevant lesion of the peripheral nervous system, disease, toxic exposure, or no known cause (i.e., idiopathic). 2. Pain distribution in a neuroanatomically plausible distribution consistent with a symmetrical generalized polyneuropathy (…
Interventions
- DrugPregabalin
300mg/day pregabalin capsule
- DrugDuloxetine
60mg/day duloxetine capsule
- OtherPlacebo
Placebo capsule
Locations (7)
- Beth Israel Deaconess Medical Center for Autonomic and Peripheral Nerve DisordersBoston, Massachusetts
- Ichan School of Medicine at Mount SinaiNew York, New York
- University of RochesterRochester, New York
- University of PittsburghPittsburgh, Pennsylvania
- University of UtahSalt Lake City, Utah
- University of VermontBurlington, Vermont