Study on Eptinezumab for Painful Diabetic Neuropathy in Adults

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What is this study about?

This clinical trial is focused on studying a condition known as painful diabetic neuropathy, which is a type of nerve pain that affects people with diabetes. The study is testing a treatment called eptinezumab, which is a type of medication known as a CGRP monoclonal antibody. This medication is being investigated to see if it can help reduce the intensity of pain experienced by individuals with this condition.

The purpose of the study is to evaluate how effective eptinezumab is in decreasing pain levels over a period of 24 weeks. Participants in the study will receive either the medication or a placebo, and their pain levels will be monitored and recorded regularly. The study aims to compare the pain relief experienced by those receiving eptinezumab with those receiving the placebo.

Throughout the study, participants will be asked to keep a diary to record their pain levels every morning. This information will help researchers understand how the treatment affects pain over time. The study will also look at other aspects of pain relief, such as the severity of neuropathic pain and the overall level of pain relief experienced at different points during the study.

1 joining the trial

Upon joining the trial, you will be informed about the study’s purpose, procedures, and your role as a participant. You will be asked to provide consent to participate in the trial.

2 baseline assessment

Before starting the treatment, a baseline assessment will be conducted. This includes recording your average pain score using a numerical rating scale (NRS) from 0 to 10, where 0 means no pain and 10 means the worst possible pain. This assessment will take place one week before the randomization.

3 randomization and first administration

You will be randomly assigned to receive either the study medication, eptinezumab, or a placebo. The medication will be administered through an intravenous infusion, which means it will be given directly into your vein. The first administration marks the beginning of the 24-week treatment period.

4 ongoing treatment and monitoring

Throughout the 24-week period, you will continue to receive the assigned treatment. Your pain intensity will be self-reported weekly using the NRS. Every fourth week, you will record your pain over the last 24 hours in a diary. This helps in assessing the change in your pain intensity over time.

5 midpoint assessment

At week 12, a midpoint assessment will be conducted. This includes evaluating the severity of your neuropathic pain using the Neuropathic Pain Scale (NPS) and assessing your pain relief, categorized as complete, good, moderate, mild, none, or worse.

6 final assessment

At the end of the 24-week period, a final assessment will be conducted. This will again involve evaluating your neuropathic pain severity using the NPS and assessing your pain relief. The results will help determine the effectiveness of the treatment.

Who Can Join the Study?

Age between 18 and 75 years.
Have a confirmed diagnosis of probable diabetic polyneuropathy. This means nerve damage caused by diabetes, confirmed by specific medical tests.
Experience probable neuropathic pain, which is pain caused by nerve damage, as defined by specific medical guidelines.
Have symmetric distal pain, meaning pain that is the same on both sides of the body, especially in the lower legs, and has been present for more than 6 months.
Have an average pain score of 4 or higher on a scale from 0 to 10 during the week before starting the study.

Who Cannot Join the Study?

Patients who do not have painful diabetic polyneuropathy cannot participate. This is a condition where people with diabetes experience pain due to nerve damage.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Both male and female patients can participate, but if you do not identify as either, you may not be eligible.
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care, like children or those unable to make decisions for themselves.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Region Midtjylland	Aarhus	Denmark
Steno Diabetes Center Copenhagen	Herlev	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	30.01.2023

Trial locations

Investigated drugs:

Eptinezumab is a type of medication known as a monoclonal antibody. It is designed to target and block a specific protein in the body called CGRP, which is involved in the transmission of pain. In this clinical trial, eptinezumab is being tested to see if it can help reduce the pain experienced by people with diabetic neuropathy, a condition that causes nerve pain due to diabetes. The goal is to see if this medication can lower the intensity of pain over a period of 24 weeks.

Investigated diseases:

Diabetic neuropathy

Painful diabetic polyneuropathy – Painful diabetic polyneuropathy is a nerve disorder caused by diabetes, affecting the peripheral nerves. It typically begins with tingling or numbness in the feet and can progress to severe pain. Over time, the pain may spread to the legs and hands. The condition can lead to a loss of sensation, making it difficult to feel injuries or temperature changes. As it progresses, it may cause muscle weakness and coordination problems. The symptoms can vary in intensity and may fluctuate over time.

Trial ID:

2022-500338-27-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Eptinezumab for Painful Diabetic Neuropathy in Adults

What is this study about?

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