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

NCT06614322 | Recruiting Phase 2 FDA Drug

• 1 other identifier: STUDY00009806
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 7

Brief 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

Keywords

Peripheral Neuropathy; Pregabalin; Duloxetine; QST

Outcome Measures

Primary Outcomes (1)

• Pain Intensity

  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.

  From enrollment to end of treatment period at 4 weeks

Secondary Outcomes (1)

• PGIC

  From enrollment to end of treatment period at 4 weeks

Study Arms (3)

Period 1 - Placebo, Placebo, Duloxetine, Duloxetine, Pregabalin, Pregabalin

EXPERIMENTAL

Participants will be randomized to 1 of the 6 possible treatment sequences

Drug: Pregabalin; Drug: Duloxetine; Other: Placebo

Period 2 - Duloxetine, Pregabalin, Placebo, Pregabalin, Duloxetine, Placebo

EXPERIMENTAL

Participants will be randomized to 1 of the 6 possible treatment sequences

Drug: Pregabalin; Drug: Duloxetine; Other: Placebo

Period 3 - Pregabalin, Duloxetine, Pregabalin, Placebo, Placebo, Duloxetine

EXPERIMENTAL

Participants will be randomized to 1 of the 6 possible treatment sequences

Drug: Pregabalin; Drug: Duloxetine; Other: Placebo

Interventions

Pregabalin DRUG

300mg/day pregabalin capsule

Period 1 - Placebo, Placebo, Duloxetine, Duloxetine, Pregabalin, Pregabalin; Period 2 - Duloxetine, Pregabalin, Placebo, Pregabalin, Duloxetine, Placebo; Period 3 - Pregabalin, Duloxetine, Pregabalin, Placebo, Placebo, Duloxetine

Duloxetine DRUG

60mg/day duloxetine capsule

Period 1 - Placebo, Placebo, Duloxetine, Duloxetine, Pregabalin, Pregabalin; Period 2 - Duloxetine, Pregabalin, Placebo, Pregabalin, Duloxetine, Placebo; Period 3 - Pregabalin, Duloxetine, Pregabalin, Placebo, Placebo, Duloxetine

Placebo OTHER

Placebo capsule

Period 1 - Placebo, Placebo, Duloxetine, Duloxetine, Pregabalin, Pregabalin; Period 2 - Duloxetine, Pregabalin, Placebo, Pregabalin, Duloxetine, Placebo; Period 3 - Pregabalin, Duloxetine, Pregabalin, Placebo, Placebo, Duloxetine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Between 18 and 80 years old (inclusive).
• Have a diagnosis of peripheral neuropathic pain in both feet from generalized distal sensory polyneuropathy based on the following criteria
• A history of a relevant lesion of the peripheral nervous system, disease, toxic exposure, or no known cause (i.e., idiopathic).
• Pain distribution in a neuroanatomically plausible distribution consistent with a symmetrical generalized polyneuropathy (i.e., with a "glove and stocking" distal to proximal gradient).
• DN4 score≥ 4
• Have experienced the neuropathic pain in the feet for at least 6 months.
• Have at least one of the following sensory signs upon clinical examination: abnormal pinprick perception, allodynia, hyperalgesia, abnormal light touch perception, abnormal vibratory perception, or abnormal proprioception.
• Have average daily baseline worst pain intensity in their feet of 4 or greater and less than 10, on a 0-10 numeric rating scale of pain intensity (0 = "no pain," 10= "most intense pain imaginable") as measured on the daily diary during screening from at least 5 measurements.
• Able to understand and read English. This requirement is to ensure that participants can provide informed consent and complete PROs.
• Have been on stable dosages of all pain medications or using all non-pharmacologic treatments for neuropathy pain at consistent frequency for at least 1 month and willing and able to stay on those dosages (or use those frequencies) (except acetaminophen rescue) throughout the duration of the study.
• If taking cannabinoid products for any reason, must be at stable dosages for at least 1 month prior to the screening visit and willing to stay on that dosage for the duration of the study.
• Willing and able to complete electronic patient-reported outcomes at home using a REDCap link.
• Taking any opioid medication with a daily mean morphine equivalent (MME) of \> 30.
• Have a different diagnosis of pain in the feet including but not limited to musculoskeletal pain (e.g., foot arthritis, plantar fasciitis) or lumbar sacral radiculopathy that they rate to be worse than their neuropathic pain in their feet, or that in the opinion of the investigator, precludes the participant from rating their neuropathy pain in their feet.
• Have a central cause of neuropathic pain (e.g., demyelinating disease, spinal cord injury, Parkinson's disease).

Sponsors & Collaborators

• University of Rochester: lead
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (7)

Beth Israel Deaconess Medical Center for Autonomic and Peripheral Nerve Disorders

Boston, Massachusetts, 02215, United States

RECRUITING

Ichan School of Medicine at Mount Sinai

New York, New York, 10029, United States

NOT YET RECRUITING

University of Rochester

Rochester, New York, 14618, United States

RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, 15206, United States

NOT YET RECRUITING

University of Utah

Salt Lake City, Utah, 84132, United States

NOT YET RECRUITING

University of Vermont

Burlington, Vermont, 05401, United States

RECRUITING

VCU Medical Center

Richmond, Virginia, 23298, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

Pregabalin; Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Thiophenes; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jennifer Gewandter, PhD, MPH

  University of Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel De Guzman

CONTACT

585-275-9361; rachel_deguzman@urmc.rochester.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study will be double-blinded, that is, the participants, study staff, and statisticians will be blinded to the treatment assignments until the study data are locked and primary analyses have been performed. Unblinding of individual treatment sequence during the study is discouraged. However, the PI at a site may break the blind for a subject in the event of a medical emergency, where knowledge of the subject's treatment sequence must be known in order to facilitate appropriate emergency medical treatment.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 26, 2024
• Study Start: January 29, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-02

Locations

US (7)