Actively Recruiting
Sensory Phenotyping to Enhance Neuropathic Pain Drug Development: A Randomized, Double-blinded Cross-over Trial to Predict Response to Analgesics Using Quantitative Sensory Testing
Led by University of Rochester · Updated on 2026-04-23
190
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Rochester
Lead Sponsor
B
Beth Israel Deaconess Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether quantitative sensory testing (QST) can help classify patients with painful peripheral neuropathy into sub-groups and predict who will respond best to certain pain treatments. This Phase 2 clinical trial evaluates the pain-relieving effects of three drugs by measuring pain intensity and Patient Global Impression of Change (PGIC). This is a randomized, double-blinded, cross-over study lasting 19 weeks, where participants receive three treatments in sequence: pregabalin (300mg/day), duloxetine (60mg/day), and a placebo capsule. Participants are assigned to one of six possible treatment sequences to compare the effects of these drugs. Participants will undergo QST exams, provide blood samples, complete computer questionnaires, and take study drugs as instructed. Pain intensity and overall patient impression of change will be measured from enrollment through the end of each 4-week treatment period. The study includes careful monitoring and data collection during the treatment and follow-up phases.
CONDITIONS
Brief Title
SPENDD: Quantitative Sensory Testing and Analgesic Response for Painful Peripheral Neuropathy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 80 years old (inclusive)
- Diagnosed with peripheral neuropathic pain in both feet from generalized distal sensory polyneuropathy
- Neuropathic pain present in feet for at least 6 months
- At least one sensory sign on clinical exam such as abnormal pinprick, allodynia, hyperalgesia, or abnormal touch/vibration/proprioception
- Average daily worst foot pain intensity of 4 or greater on a 0-10 scale during screening
- Able to understand and read English
- On stable doses of pain medications or non-drug treatments for at least 1 month and willing to maintain them during study
- Stable cannabinoid product dosage for at least 1 month if applicable
- Willing and able to complete electronic patient-reported outcomes at home
You will not qualify if you...
- Taking opioid medication with daily morphine equivalent over 30
- Having other foot pain diagnoses worse than neuropathic pain or that interfere with pain rating
- Central causes of neuropathic pain such as demyelinating disease or spinal cord injury
- History of traumatic or surgical causes leading to peripheral neuropathy symptoms
- Bilateral polyradiculopathy with distal symptoms
- Acute polyneuropathy within 6 months prior to screening
- Autoimmune neuropathy unless inflammation is controlled and stable
- Charcot-Marie-Tooth disease with nociceptive pain confounding neuropathic pain assessment
- Recent treatment causing neuropathy within 6 months
- Recent use of duloxetine or pregabalin/gabapentin within 6 months or within a week of screening
- Previous lack of benefit from both pregabalin/gabapentin and duloxetine at sufficient doses
- Use of certain medications such as venlafaxine, bupropion, tramadol, St. John's Wort, or monoamine oxidase inhibitors
- Presence of spinal cord stimulator
- Uncontrolled or unstable medical or psychiatric conditions
- Recent significant illness or surgery within 4 weeks
- Known hypersensitivity to pregabalin or duloxetine
- Chronic kidney or liver disease making participation unsafe
- Excessive alcohol consumption
- Recent illicit drug use or planned use during study (except cannabinoids)
- Significant suicide risk or danger to self/others
- Cognitive impairment or psychiatric condition interfering with assessments
- Amputation of lower limbs (except isolated toes)
- Pregnancy, planning pregnancy, or breastfeeding
- Enrolled in other investigational trials for foot pain
- Unable or unwilling to provide informed consent
- Any other investigator-determined safety concerns
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Each treatment period lasts 4 weeks in a crossover design
Participants receive randomized sequences of pregabalin, duloxetine, and placebo capsules to evaluate analgesic response.
Multiple visits during each 4-week treatment period depending on sequence assignment
Trial Site Locations
Total: 7 locations
1
Beth Israel Deaconess Medical Center for Autonomic and Peripheral Nerve Disorders
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Ichan School of Medicine at Mount Sinai
New York, New York, United States, 10029
Not Yet Recruiting
3
University of Rochester
Rochester, New York, United States, 14618
Actively Recruiting
4
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15206
Not Yet Recruiting
5
University of Utah
Salt Lake City, Utah, United States, 84132
Not Yet Recruiting
6
University of Vermont
Burlington, Vermont, United States, 05401
Actively Recruiting
7
VCU Medical Center
Richmond, Virginia, United States, 23298
Not Yet Recruiting
Research Team
R
Rachel De Guzman
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
3
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