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

NCT06614322 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2026-04-23

No results posted yet for this study

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.

Conditions

  • Painful Peripheral Neuropathy
  • Diabetic Peripheral Neuropathic Pain (DPN)
  • Chemotherapy Induced Peripheral Neuropathy (CIPN)
  • Idiopathic Peripheral Neuropathy

Interventions

DRUG

Pregabalin

300mg/day pregabalin capsule

DRUG

Duloxetine

60mg/day duloxetine capsule

OTHER

Placebo

Placebo capsule

Sponsors & Collaborators

Principal Investigators

  • Jennifer Gewandter, PhD, MPH · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-29
Primary Completion
2028-06-30
Completion
2028-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06614322 on ClinicalTrials.gov