Painful Diabetic Peripheral Neuropathy Study

STUDY BASICS

Do you have Painful Diabetic Peripheral Neuropathy (PDPN)? You may be eligible to participate in a research study to find out if different treatments have an effect on painful neuropathy due to diabetes. Compensation is provided.

STUDY PURPOSE

Painful Diabetic Peripheral Neuropathy, or PDPN,  is when diabetes damages your nerves and causes pain or numbness. If you choose to participate in this study, you will help researchers determine which new experimental pain treatments help people with PDPN. We want to find out if these treatments are safe to take without causing too many side effects. This research study will also evaluate a new experimental drug called NRD135S.E1 as a possible treatment. Your response to the study drug may give doctors more information about treating pain in people with PDPN.

COULD THIS STUDY BE RIGHT FOR YOU?

You may be eligible if you:

• Are at least 18 years old
• Have had Type II diabetes with PDPN for at least 6 months 
• Are on stable treatment of diabetes for at least 3 months
• Don't have a history of heart attacks, heart disease, or stroke 
• Aren't able to become pregnant 
• Do not use opioids, marijuana, or pain medications during the study. You can use acetaminophen (Tylenol) as needed. 

WHAT PARTICIPANTS CAN EXPECT

Eligible participants will:

• Take a study medication pill each day. You will be randomly assigned to either the medication or placebo (pill without any active ingredients).
•  Answer questions about your health and response to the medication.
• Record the time and amount of study drug and other pain medication you use each day using an app
• Wear an actigraphy device on your wrist for one week before each in-person visit. This is to measure activity (for example steps).
• Provide urine and blood samples at in-person visits. 
• Not use marijuana, illegal drugs, or some medicines which are forbidden in this study (for example, opioids like Percocet or Tramadol).