Phase 2 Peripheral Neuropathy Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged between 18 and 80 years old.
• People who have been diagnosed with nerve pain (neuropathic pain) in both feet caused by a widespread nerve condition affecting the legs and feet, where the cause may be a known illness, exposure to a toxic substance, or unknown.
• People whose foot nerve pain follows a pattern that spreads from the feet upward (sometimes described as a "glove and stocking" pattern), and who score 4 or higher on a standard nerve pain questionnaire called the DN4.
• People who have had this nerve pain in their feet for at least 6 months.
• People who show at least one abnormal sensation on physical examination, such as unusual responses to pinprick, light touch, vibration, or balance sense, or who experience pain from normally non-painful touch (allodynia) or increased pain sensitivity (hyperalgesia).
• People whose average daily worst foot pain rates between 4 and 9 out of 10 on a pain scale, based on at least 5 diary entries during the screening period.
• People who are able to read and understand English, so they can give informed consent and complete the required questionnaires.
• People who have been on a stable dose of all pain medications or non-medication pain treatments for at least 1 month and are willing to keep those doses the same throughout the study (with the exception of using acetaminophen for breakthrough pain).
• People who use cannabinoid products and have been on a stable dose for at least 1 month before screening, and are willing to keep that dose the same for the whole study.
• People who are willing and able to complete electronic questionnaires at home using a secure online link.

Who may not be able to join:

• People taking opioid pain medications at doses averaging more than 30mg of morphine equivalent per day.
• People who have another source of pain in their feet — such as arthritis, plantar fasciitis, or a back-related nerve problem — that is rated as worse than their nerve pain, or that would make it difficult to separately assess the nerve pain.
• People whose nerve pain comes from a condition affecting the brain or spinal cord (a "central" cause), such as multiple sclerosis, spinal cord injury, or Parkinson's disease.
• People whose nerve condition started after a physical injury or surgery.
• People with nerve root problems on both sides of the body that extend down into the feet.
• People who had a sudden-onset nerve condition (such as Guillain-Barré Syndrome) within the 6 months before the first visit.
• People with nerve damage caused by an autoimmune condition (such as rheumatoid arthritis, lupus, Sjögren's syndrome, Lyme disease, or a condition called CIDP), unless the underlying inflammation is well-controlled and expected to remain stable throughout the study, in the opinion of the study doctor.
• People with a hereditary nerve condition called Charcot-Marie-Tooth disease where joint-related pain makes it difficult to separately measure nerve pain.
• People who stopped taking a treatment that caused their nerve damage (such as certain chemotherapy or HIV medications) less than 6 months before the first visit.
• People who have taken duloxetine at 60mg per day or more in the past 6 months, or at any dose within one week before screening (applies to certain versions of the trial protocol only).
• People who have taken pregabalin at 300mg per day or more, or gabapentin at 1200mg per day or more, in the past 6 months, or either medication at any dose within one week before screening (applies to certain versions of the trial protocol only).
• People who have previously tried both pregabalin (or gabapentin) and duloxetine at adequate doses for adequate time, and did not get meaningful pain relief from either medication.
• People currently taking venlafaxine, bupropion, tramadol, or St. John's Wort, or who are taking more than one medication that affects serotonin levels above the doses allowed by the study (applies to certain versions of the trial protocol only).
• People currently taking a type of antidepressant called a monoamine oxidase inhibitor (MAOI) (applies to certain versions of the trial protocol only).
• People currently taking medications known as CYP1A2 inhibitors, or the antipsychotic medication thioridazine.
• People who have a spinal cord stimulator device implanted.
• People with an active, uncontrolled, or unstable serious medical condition — such as heart, kidney, liver, lung, neurological, or other major health conditions — or an uncontrolled psychiatric illness, that the study doctor believes would make participation unsafe or affect the study results.
• People who have had a significant illness or surgery within four weeks of the screening visit.
• People with a known allergy or sensitivity to pregabalin (applies to certain versions of the trial protocol only).
• People with a known allergy or sensitivity to duloxetine (applies to certain versions of the trial protocol only).
• People with a known history of chronic kidney disease that the study doctor believes would make participation unsafe.
• People with a known history of chronic liver disease that the study doctor believes would make participation unsafe.
• People who drink alcohol excessively — more than 5 drinks per day for males or more than 4 drinks per day for females.
• People who have used illicit drugs in the past year or plan to use them during the study (cannabinoid products are excluded from this restriction).
• People who, in the opinion of the study doctor, are at significant risk of suicide or of harming themselves or others, including those who have had certain suicidal thoughts in the past 6 months or a suicide attempt in the past 2 years, as assessed by a clinical interview and a standard questionnaire.
• People with signs of cognitive impairment, dementia, or a psychiatric condition such as schizophrenia or bipolar disorder that could interfere with completing the study assessments.
• People who have had a foot, ankle, leg, or thigh amputation (isolated single-toe amputations are permitted).
• People who are pregnant, planning to become pregnant during the study, or currently breastfeeding.
• People who are already enrolled in another clinical trial of an investigational medication or any pain treatment for their feet.
• People who are unable or unwilling to give informed consent.
• People whom the site investigator believes should be excluded for any other safety or study quality reason.

Important: Always verify eligibility with the trial site directly before applying.