NCT05937152

A Study of CGRP Monoclonal Antibody to Treat Diabetic Neuropathy

CAT-Trial: CGRP Monoclonal Antibody for Treatment of Painful Diabetic Neuropathy: a Double-blind, Randomized, Placebo-controlled, International Multicenter, Phase II Clinical Trial

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

In neuropathy (nerve inflammation), which is seen in diabetes and other types of damage to the nerves, pain often occurs that can be difficult to treat. Some drugs have some effect on these pains, but unfortunately the treatment is not equally effective for all patients. It is not known why some patients achieve good pain relief with a given treatment. CGRP monoclonal antibody (eptinezumab) was originally developed as a drug for migraine and works by blocking molecules called CGRP that we, based on previous studies, play a major role in pain perception. Our previous studies have shown that patients with painful diabetic neuropathy (DPN) have increased incidence of the CGRP molecules in the skin precisely where patients experience pain compared to patients with painless DPN and healthy people without neuropathy. Eptinezumab is a Food and Drug Administration (FDA) approved drug for migraines, but it is not an approved drug for the treatment of DPN. The purpose of the trial is to investigate whether the treatment has an effect on the pain in the feet experienced by some patients with diabetes.

Conditions

• Diabetic Polyneuropathy

Interventions

Type	Name	Description
DRUG	Eptinezumab	Intravenous (IV) infusion of 300 mg
DRUG	Placebo	Intravenous (IV) infusion of placebo (looks exactly like the study drug, but it contains no active ingredients)

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2023-07-10
• Last updated: 2025-03-06

Locations

3 sites across 2 countries: United States, Denmark

Regulatory

• FDA-regulated drug study