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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Intravenous (IV) infusion of 300 mg
Intravenous (IV) infusion of placebo (looks exactly like the study drug, but it contains no active ingredients)
Mayo Clinic Minnesota
Rochester, Minnesota, United States
Steno Diabetes Center Aarhus
Aarhus, Denmark
Steno Diabetes Center Copenhagen
Copenhagen, Denmark
Change in pain intensity
Weekly self-reported mean pain intensity (mean pain over the last 24 h recorded every morning in every fourth week in a diary) by the average numerical rating scale (NRS) on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.
Time frame: Baseline, 24 weeks
Change in Neuropathic Pain Severity
Measured by the total score of Neuropathic Pain Scale (NPS) on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.
Time frame: Baseline, week 12 and week 24
Pain relief at 12 weeks
Measured using a scale of complete, good, moderate, mild, none, worse
Time frame: 12 weeks
Pain relief at 24 weeks
Measured using a scale of complete, good, moderate, mild, none, worse
Time frame: 24 weeks
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