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

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Start date pushed from Jan 29, 2026 to Feb 2, 2026
    • Primary and study completion dates: Jun 2028 to Jun 1, 2028
    • Eligibility criteria expanded, about 45 words
    • Secondary endpoints: details revised at 1 of 1 entry
  2. Site details revised at 4 of 7 sites
    • Eligibility criteria shortened, about 5 words
    v5
  3. Site details revised at 2 of 7 sitesv4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2026 to Jan 29, 2026
    • Eligibility criteria expanded, about 34 words
    • Site details revised at 7 of 7 sites
    v3
  5. Start date: Sep 2025 to Jan 2026
    • Study sites: 5 to 7
    • Eligibility criteria expanded, about 383 words
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06614322
Lead Sponsor University of Rochester
Collaborators: Beth Israel Deaconess Medical Center
Conditions
(from sponsor)		 Painful Peripheral Neuropathy, Diabetic Peripheral Neuropathic Pain (DPN), Chemotherapy Induced Peripheral Neuropathy (CIPN), Idiopathic Peripheral Neuropathy
Related terms Peripheral Nervous System Diseases
Enrollment 190 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov