If only people could see what diabetic nerve pain feels like.

If you struggle with chronic nerve pain in your legs due to diabetes (diabetic peripheral neuropathy, or DPN), Vertex Pharmaceuticals is conducting research studies that may be an option.

See if you may qualify

Vertex is conducting multiple clinical research studies on pain related to DPN.

To join one of these studies, an individual must:

  • Be between the ages of 18 and 80
  • Have a diagnosis of type 1 or type 2 diabetes
  • Have pain in both legs due to DPN for at least one year

There are additional requirements for participation, which the study team will discuss with interested individuals.

About the DPN Pain Program

The purpose of these studies is to understand if an investigational drug is safe and effective for adults with pain associated with diabetic peripheral neuropathy (DPN). The word “investigational” means these medications are not yet approved for use by the US Food and Drug Administration (FDA) or other regulatory agencies in Canada, Europe, or elsewhere.

These non-opioid investigational drugs are being developed for the management of pain. They are designed to target a sodium channel in the body called Nav1.8, which plays an important role in pain signaling. Researchers are evaluating if blocking this channel will treat pain from DPN.

See if you may qualify

About Diabetic Peripheral Neuropathy (DPN)

Diabetic neuropathy is a kind of damage to the nerves that occurs in about 50% of people with diabetes. Diabetic neuropathy can affect a wide variety of nerves. When it affects the nerves of the feet, legs, arms, and hands, it is called diabetic peripheral neuropathy (DPN). DPN is the most typical form of diabetic neuropathy. Common symptoms may include but are not limited to:

  • Feelings of numbness
  • Inability to feel pain
  • Weakness of the muscles
  • A tingling or burning feeling
  • High sensitivity to touch in the affected areas
  • Ulcers, infections, joint and bone damageFootnote1

Diagnosis of DPN may occur at any age and be different based on what symptoms are present. Testing may include checking muscle strength and reflexes or biopsies of the nerves and muscles.Footnote2

References

  1. mayoclinic.org/diseases-conditions/diabetic-neuropathy/symptoms-causes/syc-20371580
  2. hopkinsmedicine.org/health/conditions-and-diseases/diabetes/diabetic-neuropathy-nerve-problems

What You Should Know about Clinical Research Studies

Clinical research studies look at an investigational drug, medical device, or procedure to see if it is safe, how it affects the body, and if it works to treat a specific disease. Clinical research studies are conducted by doctors who are responsible for the study participants’ study-related care.

In most countries, the regulatory health authority, such as the Food and Drug Administration (FDA) in the United States, requires that several phases of clinical research be performed to better understand the safety and effectiveness of new investigational drugs and certain medical devices.

Clinical research studies must be reviewed by an institutional review board (IRB) or ethics committee (EC). An IRB/EC is a group that is responsible for helping to protect the rights and well-being of study participants. In addition, every study participant is monitored with study-related medical tests and exams before, during, and sometimes even after the study.

Participation in any clinical research study is completely voluntary, and participants may choose to leave the study at any time for any reason. If you would like to leave the study, you should discuss this with your study doctor, who will give you information about how to do this safely.

Before you can take part in any of the DPN studies, you will first need to attend the screening visit(s) for initial tests and assessments to see if you are able to participate. After all the necessary tests and assessments have been completed, and you are determined to be eligible to participate, you may enter the study.

Throughout the studies in the DPN Pain Program, the study team will perform tests and procedures to check on your health. These tests and procedures include vital sign measurements, such as blood pressure and temperature; physical exams; height and weight measurements; blood and urine sample collections for lab tests; heart tests, such as electrocardiograms (ECGs); questionnaires on how you are feeling; and other assessments.

Do you struggle with pain due to diabetes?

Consider taking part in the DPN Pain Program.

See if you may qualify