RecruitingPhase 2NCT06614322

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

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.


Sponsor

University of Rochester

Enrollment

190 participants

Start Date

Jan 29, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Duloxetine, Placebo, and others for people with chemotherapy-induced peripheral neuropathy (cipn), diabetic peripheral neuropathic pain (dpn), and other related conditions. The study is currently recruiting participants at 7 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Disorders

Boston, Massachusetts, United States

Ichan School of Medicine at Mount Sinai

New York, New York, United States

University of Rochester

Rochester, New York, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

University of Utah

Salt Lake City, Utah, United States

University of Vermont

Burlington, Vermont, United States

VCU Medical Center

Richmond, Virginia, United States

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NCT06614322


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