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New treatment option for Painful Peripheral Neuropathy
Official title SPENDD: Quantitative Sensory Testing and Analgesic Response for Painful Peripheral Neuropathy.
ClinicalTrials.gov ID: NCT06614322
What this study is testing
What is Pregabalin?
Pregabalin is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for painful peripheral neuropathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Time commitment: about 19 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 5\. INCLUSION AND
You likely can't join if
- 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...
- DN4 score≥ 4
See the full eligibility criteria
Who can join
- 5\. INCLUSION AND
What rules you out
- 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...
- 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...
- 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...
- 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. Exclusion Criteria:
- 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...
- Have a central cause of neuropathic pain (e.g., demyelinating disease, spinal cord injury, Parkinson's disease).
- Have a history of an inciting traumatic or surgical cause that corresponds with the development of features consistent with a peripheral neuropathy.
- Bilateral polyradiculopathy, with a distal distribution (i.e., symptoms extending into the feet).
- History of acute polyneuropathy (e.g., Guillain-Barre Syndrome, acute motor sensory axonal neuropathy [AMSAN]) within 6 months prior to Visit 1.
- 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...
- Charcot-Marie-Tooth disease in which nociceptive pain from joint deformity confounds assessment of neuropathic pain.
- 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.
- Have taken duloxetine (at least 60mg/day) in the past 6 months or have taken duloxetine at any dosage within a week prior to the screening visit.\ \
- Have taken pregabalin (at least 300mg/day) OR gabapentin (at least 1200mg/day) in the past 6 months or have taken pregabalin or gabapentin at any dosage within a week prior to the screening visit.##
- Have ever previously taken BOTH pregabalin (or gabapentin) AND duloxetine at sufficient dosages and for a sufficient length of time that, in the opinion of the investigator, the participant should have experienced pain...
- Taking venlafaxine, buproprion, tramadol, or St. John's Wort. Concomitant use of one medication that inhibits the reuptake of serotonin is allowed at certain dosages. (See Appendix A for maximum allowed dosages for...
- Taking a monoamine oxidase inhibitor.\ \
- Taking CYP1A2 inhibitors or thioridazine.
- Have a spinal cord stimulator.
- Have an active, uncontrolled/unstable medical condition (e.g., neurological, gastrointestinal, renal, hepatic, cardiovascular, pulmonary, metabolic, endocrine, hematological, genitourinary, cancer, or other major...
- Had a clinically significant illness or operative procedure within four weeks of screening.
- Known hypersensitivity to pregabalin. ##
- Known hypersensitivity to duloxetine.\ \
- Known history of chronic kidney disease that in the opinion of the investigator would make it unsafe to participate.
- Known history of chronic liver disease that in the opinion of the investigator would make it unsafe to participate.
- Excessive consumption of alcohol (i.e., more than 5 drinks / day for males and more than 4 drinks / day for females).
- A history of illicit drug use in the past year or planning to take any illicit drugs during the course of the study (other than cannabinoid products).
- Patients who are at significant risk of suicide, or are a danger to self or others, in the opinion of the investigator, based upon clinical interview and the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening...
- Evidence of cognitive impairment including dementia or a psychiatric condition (e.g., schizophrenia, bipolar disorder) that may interfere with the subject's ability to complete assessments.
- Amputation of lower limbs (foot, ankle, leg, or thigh). Isolated toe amputations are permitted.
- Pregnant or planning to become pregnant during the study period or breastfeeding (screened via self-report).
- Enrolled in another investigational medication trial or a trial of any intervention for pain in your feet.
- Unable or unwilling to provide informed consent.
- Any additional reason that, in the opinion of the site investigator, would make it unsafe to participate or inclusion of the participant would hurt the study.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- New York, New York, United States
- Rochester, New York, United States
- Pittsburgh, Pennsylvania, United States
- Salt Lake City, Utah, United States
- Burlington, Vermont, United States
- Richmond, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 19 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; New York, New York, United States; Rochester, New York, United States; Pittsburgh, Pennsylvania, United States; Salt Lake City, Utah, United States; Burlington, Vermont, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.