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.
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Painful Peripheral Neuropathy
- Sponsor
- University of Rochester
- Enrollment
- 190
- Locations
- 12
- Primary Endpoint
- Pain Intensity
- Status
- Recruiting
- Last Updated
- 19 days ago
Overview
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.
Investigators
Jennifer Gewandter
Associate Professor
University of Rochester
Eligibility Criteria
Inclusion Criteria
- •5\. INCLUSION AND
Exclusion Criteria
- •Inclusion Criteria:
- •Patients eligible for inclusion in this study must fulfill all of the following criteria:
- •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.
Arms & Interventions
Period 1 - Placebo, Placebo, Duloxetine, Duloxetine, Pregabalin, Pregabalin
Participants will be randomized to 1 of the 6 possible treatment sequences
Intervention: Placebo
Period 2 - Duloxetine, Pregabalin, Placebo, Pregabalin, Duloxetine, Placebo
Participants will be randomized to 1 of the 6 possible treatment sequences
Intervention: Placebo
Period 3 - Pregabalin, Duloxetine, Pregabalin, Placebo, Placebo, Duloxetine
Participants will be randomized to 1 of the 6 possible treatment sequences
Intervention: Placebo
Period 3 - Pregabalin, Duloxetine, Pregabalin, Placebo, Placebo, Duloxetine
Participants will be randomized to 1 of the 6 possible treatment sequences
Intervention: Duloxetine
Period 2 - Duloxetine, Pregabalin, Placebo, Pregabalin, Duloxetine, Placebo
Participants will be randomized to 1 of the 6 possible treatment sequences
Intervention: Pregabalin
Period 1 - Placebo, Placebo, Duloxetine, Duloxetine, Pregabalin, Pregabalin
Participants will be randomized to 1 of the 6 possible treatment sequences
Intervention: Pregabalin
Period 1 - Placebo, Placebo, Duloxetine, Duloxetine, Pregabalin, Pregabalin
Participants will be randomized to 1 of the 6 possible treatment sequences
Intervention: Duloxetine
Period 3 - Pregabalin, Duloxetine, Pregabalin, Placebo, Placebo, Duloxetine
Participants will be randomized to 1 of the 6 possible treatment sequences
Intervention: Pregabalin
Period 2 - Duloxetine, Pregabalin, Placebo, Pregabalin, Duloxetine, Placebo
Participants will be randomized to 1 of the 6 possible treatment sequences
Intervention: Duloxetine
Outcomes
Primary Outcomes
Pain Intensity
Time Frame: 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 Outcomes
- PGIC(From enrollment to end of treatment period at 4 weeks)