Is diabetes causing you pain?, Tingling?, Numbness?
If yes, you may have a condition known as painful Diabetic Peripheral Neuropathy (painful DPN).
What is Diabetic Peripheral Neuropathy?
DPN refers to various types of nerve damage associated with diabetes mellitus like numbness, tingling, pain, etc.
If you wanna more info about DPN, you can gi to this link.
Symptoms of DPN
Symptoms depend on the site of nerve damage and can include motor changes such as weakness; sensory symptoms such as numbness, tingling, or pain; or autonomic changes such as urinary symptoms.
What is the RiNeuD study?
The RiNeuD study is a clinical research study for people who have type 1 or type 2 diabetes that has led to painful Diabetic Peripheral Neuropathy. The goal of the RiNeuD study is to find out if the study medication can provide relief from the pain, tingling, and numbness associated with painful DPN. The study medication may be able to restore cells, called neurons, that transport messages between the brain and other parts of the body.
Who can join the study?
You may be able to join the RiNeuD study if you meet the following study requirements:
- Between 18 and 80 years of age
- Diagnosed with diabetes (type 1 or type 2) at least 6 months ago
- Have pain, tingling, numbness, or weakness in the hands, legs, or feet
- Other study requirements will apply
What can study participants expect?
Study participation will last about 8.5 months and will include the following periods:
- Screening period (4 weeks) – You will have study assessments and procedures to find out if you can join the study.
- Single-Blinded Pain Recording period (2 weeks) – You will be assigned at random (like a coin flip) to receive either the study medication or placebo (no active ingredients). Single-blinded means that you will not know which you receive, but the study doctor will know. You will drink the study medication or placebo every morning and record your pain levels in an electronic study diary. You will attend 1 visit at the study center and receive 1 phone call.
- Double-Blinded Study Medication period (12 weeks) – You will be re-assigned to receive either the study medication or placebo. Double-blinded means that neither you nor the study doctor will know which you receive. You will drink the study medication or placebo every morning and record your pain levels in the study diary. You will visit the study center 4 times and have study assessments and procedures.
- Open-Label Safety period (12 weeks) – You will take the study medication with no chance of receiving placebo. You will drink the study medication every morning and record your pain levels in the study diary. You will visit the study center 5 times and have study assessments and procedures.
- Follow-up period (4 weeks) – After you stop taking the study medication, you will attend 2 visits at the study center, so the study doctor can check your health.