SPENDD: Quantitative Sensory Testing and Analgesic Response for Painful Peripheral Neuropathy.

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Rochester

About this trial

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 criteria

Qualifiers

None

Disqualifiers

Between 18 and 80 years old (inclusive).

Have a diagnosis of peripheral neuropathic pain in both feet from generalized distal sensory polyneuropathy based on the following criteria

A history of a relevant lesion of the peripheral nervous system, disease, toxic exposure, or no known cause (i.e., idiopathic).

Pain distribution in a neuroanatomically plausible distribution consistent with a symmetrical generalized polyneuropathy (i.e., with a "glove and stocking" distal to proximal gradient).

Trial design

Treatments tested in this trial

  • Pregabalin
  • Duloxetine
  • Placebo

Treatment groups

190 Participants
are divided into 3 treatment groups

Sponsors and collaborators

University of Rochester

Lead sponsor

Beth Israel Deaconess Medical Center

Collaborator