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

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

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-80

SponsorUniversity of Rochester

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Exclusion criteria 10, 13, 14, 20 pertain only to trial protocols that include duloxetine.

Exclusion criterion 11, 19 pertain only to trial protocols that include pregabalin.

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.

Trial design

Design model

Crossover

Treatments tested in this trial

Pregabalin
Drug
300mg/day pregabalin capsule
Duloxetine
Drug
60mg/day duloxetine capsule
Placebo
Other intervention
Placebo capsule

Treatment groups

190 Participants

are divided into 3 treatment groups

Group A: Period 1 - Placebo, Placebo, Duloxetine, Duloxetine, Pregabalin, PregabalinExperimental treatment 3 interventions

Group B: Period 2 - Duloxetine, Pregabalin, Placebo, Pregabalin, Duloxetine, PlaceboExperimental treatment 3 interventions

Group C: Period 3 - Pregabalin, Duloxetine, Pregabalin, Placebo, Placebo, DuloxetineExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

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.

Time frame

From enrollment to end of treatment period at 4 weeks

Secondary outcomes

PGIC

PGIC will be rated using the following question: "Since the beginning of this treatment period, my overall pain is.. \[very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse\]"

Time frame

From enrollment to end of treatment period at 4 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Rochester

Lead sponsor

Beth Israel Deaconess Medical Center

Collaborator

Source ClinicalTrials.gov

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