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Monoclonal Antibodies

Eptinezumab for Diabetic Neuropathy

Phase 2

Recruiting

Led By Narayan Kissoon, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Symmetric distal pain worse in the distal lower extremities present for > 6 months.

Confirmed diagnosis of probable diabetic polyneuropathy, as defined by the Toronto consensus criteria and a TCNS > 5 or abnormal DPNCheck or abnormal NCS.

Must not have

The patient has a history of clinically significant cardiovascular disease, including uncontrolled hypertension, ischaemia or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism).

Planned larger surgery in the treatment period.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 12 and week 24

Summary

This trial will compare a drug to placebo to see if it reduces pain in people with diabetic nerve pain. #DPN #eptinezumab #CGRP

Who is the study for?

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.

What is being tested?

The study tests the effectiveness of Eptinezumab (a CGRP monoclonal antibody) against a placebo in reducing pain intensity in patients with diabetic polyneuropathy. Participants will be randomly assigned to receive either the medication or placebo to compare outcomes.

What are the potential side effects?

While not specified here, CGRP monoclonal antibodies like Eptinezumab may cause side effects such as injection site reactions, constipation, muscle spasms and possibly elevated blood pressure. Individual experiences can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had pain in my feet and lower legs for more than 6 months.

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I have been diagnosed with diabetic nerve damage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of serious heart or blood vessel problems.

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I am scheduled for a major surgery during the treatment period.

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I am on a stable, low dose of Tramadol (200 mg/day or less) or not taking opioids.

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I have poor blood flow in my legs, indicated by low toe pressure or lack of foot pulses.

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I have used CGRP inhibitors for treatment.

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I have long-lasting, non-healing wounds.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 12 and week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 12 and week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 12 and week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in pain intensity

Secondary study objectives

Change in Neuropathic Pain Severity

Pain relief at 12 weeks

Pain relief at 24 weeks

Side effects data

From 2020 Phase 3 trial • 485 Patients • NCT04152083

Hypersensitivity

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Eptinezumab

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Open-label Eptinezumab GroupExperimental Treatment1 Intervention

At the end of the placebo-controlled treatment period, all participants will have the option to continue into the 24-week long active study treatment period and will receive 2 infusions of eptinezumab.

Group II: Eptinezumab GroupExperimental Treatment1 Intervention

Subjects diagnosed with diabetic polyneuropathy (DPN) will receive 2 infusions of eptinezumab during the 24 week-long placebo-controlled treatment period.

Group III: Placebo GroupPlacebo Group1 Intervention

Subjects diagnosed with diabetic polyneuropathy (DPN) will receive 2 infusions of placebo during the 24-week long placebo-controlled treatment period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Eptinezumab

2021

Completed Phase 3

~2200

0 / 8Eligibility criteria met