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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
University of Rochester
Study ID
NCT06614322
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Pregabalin — DRUG
    300mg/day pregabalin capsule
  • Duloxetine — DRUG
    60mg/day duloxetine capsule
  • Placebo — OTHER
    Placebo capsule

Study Details

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.

Key Dates

Start date
Jan 29, 2026
Status verified
Feb 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
190 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Period 1 - Placebo, Placebo, Duloxetine, Duloxetine, Pregabalin, Pregabalin
    Participants will be randomized to 1 of the 6 possible treatment sequences
  • Experimental: Period 2 - Duloxetine, Pregabalin, Placebo, Pregabalin, Duloxetine, Placebo
    Participants will be randomized to 1 of the 6 possible treatment sequences
  • Experimental: Period 3 - Pregabalin, Duloxetine, Pregabalin, Placebo, Placebo, Duloxetine
    Participants will be randomized to 1 of the 6 possible treatment sequences

Primary Outcome Measure

Pain Intensity [ Time Frame: From enrollment to end of treatment period at 4 weeks ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical Center for Autonomic and Peripheral Nerve DisordersBostonMassachusetts02215
Nicholas Steed
[email protected]
617-632-8454
Roy Freeman, MD (PRINCIPAL_INVESTIGATOR)
Ichan School of Medicine at Mount SinaiNew YorkNew York10029
Kaitlyn Coyle
[email protected]
212-241-0190
Jessica Robinson-Papp, MD (PRINCIPAL_INVESTIGATOR)
University of RochesterRochesterNew York14618
Rachel De Guzman
[email protected]
585-275-9361
Jennifer Gewandter, PhD, MPH (PRINCIPAL_INVESTIGATOR)
University of PittsburghPittsburghPennsylvania15206
Bhagyasri Dharmaraj
[email protected]
412-665-8048
Ajay Wasan, MD (PRINCIPAL_INVESTIGATOR)
University of UtahSalt Lake CityUtah84132
Mariana Doudova
[email protected]
801-581-3818
Rob Singleton, MD (PRINCIPAL_INVESTIGATOR)
University of VermontBurlingtonVermont05401
Jane Low
[email protected]
(802) 847-0983
Noah Kolb, MD (PRINCIPAL_INVESTIGATOR)
VCU Medical CenterRichmondVirginia23298
Stephanie Taylor
[email protected]
804-628-5734
Gordon Smith, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Beth Israel Deaconess Medical Center for Autonomic and Peripheral Nerve Disorders· Boston, MAIchan School of Medicine at Mount Sinai· New York, NYUniversity of Rochester· Rochester, NYUniversity of Pittsburgh· Pittsburgh, PAUniversity of Utah· Salt Lake City, UTUniversity of Vermont· Burlington, VT

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