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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 12 and week 24
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have had pain in my feet and lower legs for more than 6 months.
Select...
I have been diagnosed with diabetic nerve damage.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in pain intensity
Secondary outcome measures
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 • NCT041520832%
Hypersensitivity
100%
80%
60%
40%
20%
0%
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
~2040
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,216 Previous Clinical Trials
3,767,388 Total Patients Enrolled
Narayan Kissoon, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
2 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had pain in my feet and lower legs for more than 6 months.I have nerve pain as defined by specific guidelines.My leg pain is not caused by diabetes but could be due to other reasons like chemotherapy or vitamin deficiency.I have been diagnosed with diabetic nerve damage.I am scheduled for a major surgery during the treatment period.I haven't started new pain medications like gabapentin or capsaicin in the last month.I am on a stable, low dose of Tramadol (200 mg/day or less) or not taking opioids.I have a history of serious heart or blood vessel problems.I have poor blood flow in my legs, indicated by low toe pressure or lack of foot pulses.Your average pain score is 4 or higher on a pain scale during the baseline week.I have used CGRP inhibitors for treatment.I have long-lasting, non-healing wounds.You have a body mass index (BMI) of 39 or higher.I do not have a history of severe mental health issues like psychosis, bipolar mania, or dementia.
Research Study Groups:
This trial has the following groups:- Group 1: Eptinezumab Group
- Group 2: Placebo Group
- Group 3: Open-label Eptinezumab Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the trial criterion allow individuals above 45 to participate?
"This clinical trial is recruiting patients between the ages of 18 and 75 years."
Answered by AI
Has the Eptinezumab Group received clearance from the Food and Drug Administration?
"Our team has evaluated eptinezumab's safety on a scale from 1 to 3 and determined that it should receive a 2, since Phase 2 trials have established proof of concept but lack efficacy data."
Answered by AI
Who satisfies the eligibility criteria to join this clinical trial?
"To qualify for this research, applicants must be diagnosed with diabetic polyneuropathy and should fall between the age of 18 to 75. Ultimately, 100 individuals need to take part in these studies."
Answered by AI
Is this research endeavor open to new participants?
"According to the clinicaltrials.gov page, this medical trial is no longer accepting participants at present. The study was initially posted on July 1st 2023 and last updated June 30th of that same year. However, there are 72 other trials actively recruiting candidates currently."
Answered by AI
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