Loading clinical trials...

SPENDD: Quantitative Sensory Testing and Analgesic Response for Painful Peripheral Neuropathy. | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

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.

NCT06614322•University of Rochester

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients eligible for inclusion in this study must fulfill all of the following criteria:
•1. Between 18 and 80 years old (inclusive).
•2. Have a diagnosis of peripheral neuropathic pain in both feet from generalized distal sensory polyneuropathy based on the following criteria
•1. A history of a relevant lesion of the peripheral nervous system, disease, toxic exposure, or no known cause (i.e., idiopathic).
•2. Pain distribution in a neuroanatomically plausible distribution consistent with a symmetrical generalized polyneuropathy (i.e., with a "glove and stocking" distal to proximal gradient).
•3. DN4 score≥ 4
•3. Have experienced the neuropathic pain in the feet for at least 6 months.
•4. 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.
•5. 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.
•6. Able to understand and read English. This requirement is to ensure that participants can provide informed consent and complete PROs.
+2 more criteria

Exclusion Criteria

•* Exclusion criterion 11, 19 pertain only to trial protocols that include pregabalin.
•1. Taking any opioid medication with a daily mean morphine equivalent (MME) of \> 30.
•2. 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.
•3. Have a central cause of neuropathic pain (e.g., demyelinating disease, spinal cord injury, Parkinson's disease).
•4. Have a history of an inciting traumatic or surgical cause that corresponds with the development of features consistent with a peripheral neuropathy.
•5. Bilateral polyradiculopathy, with a distal distribution (i.e., symptoms extending into the feet).
•6. History of acute polyneuropathy (e.g., Guillain-Barre Syndrome, acute motor sensory axonal neuropathy \[AMSAN\]) within 6 months prior to Visit 1.
•7. Have autoimmune-mediated neuropathy (e.g., RA, lupus, Sjogren syndrome, Lyme disease, chronic inflammatory demyelinating polyneuropathy (CIDP)) unless the associated inflammation is controlled and, in the opinion of the investigator, is expected to remain stable throughout the course of the study.
•8. Charcot-Marie-Tooth disease in which nociceptive pain from joint deformity confounds assessment of neuropathic pain.
•9. Have taken the treatment that caused the participant's neuropathy (e.g., neurotoxic chemotherapy, certain HIV therapies) less than 6 months prior to Visit 1.
+22 more criteria

Locations (7)

Beth Israel Deaconess Medical Center for Autonomic and Peripheral Nerve Disorders

Boston, Massachusetts, United States

Ichan School of Medicine at Mount Sinai

New York, New York, United States

University of Rochester

Rochester, New York, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

University of Utah

Salt Lake City, Utah, United States

University of Vermont

Burlington, Vermont, United States

VCU Medical Center

Richmond, Virginia, United States

Key Dates

Start Date

January 1, 2026

Primary Completion Date

June 1, 2028

Completion Date

June 1, 2028

Last Updated

December 15, 2025

Enrollment

190

ESTIMATED participants

Conditions

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

Interventions

Pregabalin

DRUG

Duloxetine

DRUG

Placebo

OTHER

Contacts

Rachel De Guzman

CONTACT

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

Gut Microbiome Profiles in Patients with Chemotherapy-induced Neuropathy in the RCT OzoParQT (NCT06706544).

NCT06799351

Chemotherapy Induced Peripheral Neuropathy (CIPN)Paresthesia+2 more

View study

NOT_YET_RECRUITINGNA

Preliminary Effectiveness and Feasibility of Transcutaneous Acupoints Electrical Stimulation on Chemotherapy-induced Peripheral Neuropathy Among Children With Acute Lymphoblastic Leukemia

NCT07319481

Chemotherapy Induced Peripheral Neuropathy (CIPN)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Gut Microbiome Profiles in Patients with Chemotherapy-induced Neuropathy in the RCT OzoParQT (NCT06706544).

Preliminary Effectiveness and Feasibility of Transcutaneous Acupoints Electrical Stimulation on Chemotherapy-induced Peripheral Neuropathy Among Children With Acute Lymphoblastic Leukemia

Simple Surgical Glove Compression to Prevent Chemotherapy-Induced Peripheral Neuropathy

Neoadjuvant FOLFOX Chemotherapy for Colon Cancer: Long-Term Chemotherapy-Induced Peripheral Neuropathy and Impact on Quality of Life