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NCT06614322 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by University of Rochester.

Recruiting
Registry status
Phase 2
Development phase
190
Enrollment target

NCT06614322: Recruiting Phase 2 study, sponsored by University of Rochester.

NCT06614322 is a Phase 2 study that is actively recruiting participants, run by University of Rochester. The registered enrollment target is 190 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06614322, a Phase 2 study, is actively recruiting participants, sponsored by University of Rochester.

RECRUITING
Registry status
Phase 2
Development phase
190 participants
Enrollment target

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.

Primary Outcome

Pain intensity will be measured using the following question: "Please rate your worst pain over the past day on a scale from 0 to 10 (0 = no pain, 10 = worst pain imaginable). The primary outcome will be the mean of 7 daily worst pain ratings. It will be assessed during the baseline week of each period (i.e., week before randomization and the last week of each washout period) and during the 4th week of treatment in each period.

Interventions

  • OTHER Placebo
  • DRUG Duloxetine
  • DRUG Pregabalin

Trial Details

FieldValue
Enrollment Target 190 participants
Start Date 2026-01-29
Est. Completion 2028-06
Phase Phase 2
University of Rochester

636 total trials

What NCT06614322 shows while recruiting

NCT06614322 is an interventional study that assigns participants to a tested intervention. The registered 190 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% higher).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT06614322 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06614322 about?

NCT06614322 is a clinical study titled "SPENDD: Quantitative Sensory Testing and Analgesic Response for Painful Peripheral Neuropathy.". 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 ...

What is the current status of trial NCT06614322?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 190 participants. The study started on 2026-01-29. Estimated completion is 2028-06.

What interventions are being tested in trial NCT06614322?

The interventions under investigation include: Placebo (OTHER), Duloxetine (DRUG), Pregabalin (DRUG).

Who is sponsoring clinical trial NCT06614322?

This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06614322's enrollment target sits among peer trials

190 353rd of 2000 higher than 1,646 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06614322, the US trial registry maintained by the National Library of Medicine. NCT06614322 (mid enrollment · none site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.