Do you suffer from discomfort or pain caused by Distal Sensory Polyneuropathy (DSP)?
This study is designed to assess efficacy and safety of treatment with an experimental medication for Distal Sensory Polyneuropathy (DSP).
Distal Sensory Polyneuropathy (DSP) is a type of peripheral neuropathy that primarily affects the sensory nerves in the body’s extremities, such as the hands and feet. It is characterized by numbness, tingling, pain, and sometimes weakness in these areas. The condition often results from damage to the small nerve fibers, typically caused by chronic conditions such as diabetes, HIV, or certain toxins. DSP can lead to a loss of sensation and, in severe cases, may impair a person’s ability to perform daily activities.
Would you like to take part?
As a volunteer in a research study, you’ll receive study-related medical care from the study doctor and regular study-related follow up on your health to monitor the effectiveness of the care you’ll receive. The results of this research will be used to determine whether or not the medication being studied will be of benefit to others with DSP. Study volunteers are an important part of moving medical care forward.
You may qualify to participate in this study if you:
- Are 18 years of age or older at the time of signing informed consent
- Have a VAS pain value greater than or equal to 40 and less than 95 at the time of Visit 1
- Are willing to enter required data daily throughout the 24-week duration of the study
- Experience the presence of painful DSP without prominent motor or automatic features with gradual or insidious onset with a maximum duration of 6 months and a known cause of nerve injury, such as metabolic, toxic exposure, nutritional, immunologic, infection, hereditary, multifactorial, or no known cause identified
- Show the presence of at least 1 clinician-rated assessed sensory signs of DSP:
- decreased sensation to light touch
- decreased sensation to pinprick
- allodynia by brushing
- hyperalgesia by pinprick
- reflex abnormality
- Are willing to maintain a consistent regimen of any ongoing nonpharmacological pain-relieving therapies and/or nutritional supplements and will not start any new nonpharmacological pain-relieving therapies and/or nutritional substances during study participation
- Are willing to discontinue all medications taken for chronic pain conditions, expect the allowed concomitant pain medication permitted per study protocol, which is acetaminophen for the duration of the study
- Have a BMI less than or equal to 45 kg/m^2
You may not qualify to participate in this study if you:
- Have a history of other potentially causative and/or confounding sources of pain that may impair self-assessment of pain due to painful DSP, including but not limited to:
- history of acute polyneuropathy
- history of chronic inflammatory demyelinating polyneuropathy
- autoimmune-related neuropathy
- hereditary neuropathies
- Charcot-Marie-Tooth disease in which nociceptive pain from joint deformity confounds assessment of neuropathic pain
- focal neuropathies
- neuropathy secondary to COVID and Lyme disease
- Presence of sciatica
- Have a history of other potentially confounding sources of pain that may impair self-assessment of pain due to painful DSP, including but not limited to:
- symptomatic peripheral vascular disease
- clinically significant peripheral edema
- presence of fibromyalgia
- Have had procedures for treatment of painful DSP within the following time frame:
- procedure within the past 6 months prior to screening indented to produce permanent sensory loss in the target area of interest
- therapeutic injection within 90 days prior to screening
- capsaicin application to the feet within 6 months of screening
- Use spinal cord stimulation or other stimulation device
- Have not achieved glycemic control on a stable diabetes treatment regimen for at least 90 days prior to screening with glucose-lowering agents and/or subcutaneous insulin or diet and exercise, in the opinion of the investigator for participants diagnosed with Type 1 or Type 2 diabetes
- Have HbA1c greater than 11 at screening
- Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy that requires immediate treatment intervention
- Have hepatitis infection, defined as:
- positive hepatitis B surface antigen, or
- positive for both hepatitis B core antibody and positive for HBV DNA
- positive hepatitis C antibody and positive for HCV RNA
- Have a history or presence of severe hepatic disease including cirrhosis
- Have been diagnosed with cancer within 2 years of screening
- Display evidence of clinically significant or unstable psychiatric disease by medical history
- Have a history or presence of uncontrolled asthma, uncontrolled eczema, significant atopy or common variable immune deficiency
There are other eligibility requirements that the study doctor will review. Only the study doctor can finally determine whether you are eligible to participate in the study or not.
