Trials / Recruiting
RecruitingNCT06614322
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.
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 190 (estimated)
- Sponsor
- University of Rochester · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Pregabalin | 300mg/day pregabalin capsule |
| DRUG | Duloxetine | 60mg/day duloxetine capsule |
| OTHER | Placebo | Placebo capsule |
Timeline
- Start date
- 2026-01-29
- Primary completion
- 2028-06-01
- Completion
- 2028-06-01
- First posted
- 2024-09-26
- Last updated
- 2026-04-13
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06614322. Inclusion in this directory is not an endorsement.