Eptinezumab for Diabetic Neuropathy
What You Need to Know Before You Apply
What is the purpose of this trial?
The main purpose of this study is to compare the change in pain intensity during treatment with a CGRP monoclonal antibody (eptinezumab) compared with placebo treatment in patients with painful diabetic polyneuropathy (DPN).
Do I have to stop taking my current medications for the trial?
The trial does not require you to stop your current medications if they are stable doses of anticonvulsants, antidepressants, tramadol, or topical treatments (excluding high dose capsaicin patch and botulinum toxin type A). However, you cannot start new neuropathic pain medications like gabapentin, pregabalin, or certain antidepressants one month before or during the trial.
What safety data is available for Eptinezumab (Vyepti) in treating diabetic neuropathy?
Is the drug Eptinezumab a promising treatment for diabetic neuropathy?
What data supports the idea that Eptinezumab for Diabetic Neuropathy is an effective treatment?
The available research does not provide any data on Eptinezumab for Diabetic Neuropathy. Instead, it focuses on Janus kinase inhibitors for other conditions like rheumatoid arthritis, juvenile dermatomyositis, and diabetic kidney disease. Therefore, there is no information here to support the effectiveness of Eptinezumab for Diabetic Neuropathy.1112131415
Who Is on the Research Team?
Narayan Kissoon, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for adults with painful diabetic neuropathy who've had symptoms for over 6 months, have a pain score of ≥4, and meet specific diagnostic criteria. Excluded are those on high-dose opioids or other recent neuropathic treatments, with chronic wounds, planned major surgery, BMI ≥39 kg/m^2, history of certain mental health conditions or significant cardiovascular disease.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 2 infusions of eptinezumab or placebo during the 24-week placebo-controlled treatment period
Open-label extension
Participants have the option to continue into a 24-week active study treatment period with eptinezumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Eptinezumab
Eptinezumab is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor