Chemotherapy Induced Peripheral Neuropathy (CIPN), Diabetic Peripheral Neuropathic Pain (DPN), Idiopathic Peripheral Neuropathy, Painful Peripheral Neuropathy
Conditions
Keywords
Peripheral Neuropathy, Pregabalin, Duloxetine, QST
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.
Interventions
DRUGPregabalin
300mg/day pregabalin capsule
DRUGDuloxetine
60mg/day duloxetine capsule
OTHERPlacebo
Placebo capsule
Sponsors
University of Rochester
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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≥ 4.4 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. 7. 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. 8. 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. 9. Willing and able to complete electronic patient-reported outcomes at home using a REDCap link.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | From enrollment to end of treatment period at 4 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PGIC | From enrollment to end of treatment period at 4 weeks | PGIC will be rated using the following question: "Since the beginning of this treatment period, my overall pain is.. \[very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse\]" |
Countries
United States
Contacts
CONTACTRachel De Guzman
PRINCIPAL_INVESTIGATORJennifer Gewandter, PhD, MPH
University of Rochester
Outcome results
None listed