🏛️ Verified NIH Protocol • Sourced via U.S. National Library of Medicine (Last Synced: 2026-04-23)

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

🟢 Recruiting Phase 2 💊 Investigational Drug / Biologic Sponsor: University of Rochester

🩺 Protocol 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.

Primary Research Facility: Beth Israel Deaconess Medical Center for Autonomic and Peripheral Nerve Disorders (Boston, Massachusetts)

📋 Basic Study Criteria & Logistics Checklist

0 of 3 Checked

Review these 3 basic logistical and protocol criteria extracted from the public NIH record. (This is a preliminary logistical checklist, not an official clinical eligibility determination).

Diagnosed with, undergoing evaluation for, or seeking treatment related to Painful Peripheral Neuropathy?

🔍 Study Population / Focus Area (Source: Protocol Primary Condition)

Aged between 18 Years and 80 Years?

🔍 Protocol Specified Age Range: 18 Years to 80 Years

Able to attend required in-person clinic visits and study procedures at one of the participating study centers?

🔍 Logistical Requirement: 7 Registered Participating Sites

📍 Primary Site Map

Site: Beth Israel Deaconess Medical Center for Autonomic and Peripheral Nerve Disorders — Boston, Massachusetts

📍 All Participating Trial Locations (7 Sites)

Multi-Center Trial

This protocol is enrolling participants across multiple clinical centers:

1. Beth Israel Deaconess Medical Center for Autonomic and Peripheral Nerve Disorders — Boston, Massachusetts • Contact: (617) 632-8454

2. Ichan School of Medicine at Mount Sinai — New York, New York • Contact: (212) 241-0190

3. University of Rochester — Rochester, New York • Contact: (585) 275-9361

4. University of Pittsburgh — Pittsburgh, Pennsylvania • Contact: (412) 665-8048

5. University of Utah — Salt Lake City, Utah • Contact: (801) 581-3818

6. University of Vermont — Burlington, Vermont • Contact: (802) 847-0983

7. VCU Medical Center — Richmond, Virginia • Contact: (804) 628-5734

📄 Print Doctor Discussion Sheet

Preview and print a 1-page summary with 5 tailored questions for your physician.

💰 Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act § 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

💡 Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.

🏛️ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT06614322 • Last Synced: 2026-04-23

View on ClinicalTrials.gov ↗