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NEW Diabetes and Pain Medication Study

Phase 2
Recruiting
Led By Jessica Robinson-Papp, MD
Research Sponsored by James P. Rathmell, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Do you have pain in your lower extremities (legs, feet, toes, ankles, etc.)?
Do you have Type 2 Diabetes?
Must not have
Have you had a heart attack or stroke?
Timeline
Screening 45 weeks
Treatment 12 weeks
Follow Up 107 days
Awards & highlights

Study Summary

This trial will test treatments for painful diabetic nerve pain. It's part of the NIH's HEAL Initiative.

Who is the study for?
This trial is for people with Type 2 Diabetes who suffer from painful diabetic neuropathy, specifically pain in the lower extremities. Participants should have stable diabetes treatment for at least three months without expected changes in their medication regimen. Those who've had a recent heart attack or stroke cannot join.Check my eligibility
What is being tested?
The study is part of EPPIC-Net and aims to test various treatments for Painful Diabetic Peripheral Neuropathy (PDPN) using a platform protocol that allows multiple drugs to be tested under one overarching study design.See study design
What are the potential side effects?
Since specific interventions are not listed, side effects will vary depending on the particular treatment being tested but may include typical drug-related reactions such as nausea, dizziness, skin irritation, or other symptoms related to nerve pain medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I experience pain in my legs, feet, toes, or ankles.
Select...
I have Type 2 Diabetes.
Select...
I have diabetic neuropathy.
Select...
My diabetes treatment has been stable for at least 3 months with no expected changes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a heart attack or stroke.

Timeline

Screening ~ 45 weeks
Treatment ~ 12 weeks
Follow Up ~107 days
This trial's timeline: 45 weeks for screening, 12 weeks for treatment, and 107 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Daily 0-10 pain NRS
Secondary outcome measures
Generalized Anxiety Disorder - 2 item scale (GAD-2)
Opioid Use Questionnaire (OUQ)
PROMIS Physical Functioning Short-Form 6b
+7 more
Other outcome measures
Neuropathy Examination
Norfolk Quality of Life - Diabetic Neuropathy (Norfolk QOL-DN)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: EN21-01 ISAExperimental Treatment1 Intervention
The EN21-01 Intervention Specific Analysis is detailed in the protocol (NCT#)
Group II: Placebo ComparatorPlacebo Group1 Intervention
Each ISA will detail the use of the Placebo Comparator.

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

New York UniversityOTHER
225 Previous Clinical Trials
312,753 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,337 Previous Clinical Trials
648,722 Total Patients Enrolled
James P. Rathmell, MDLead Sponsor
1 Previous Clinical Trials
122 Total Patients Enrolled

Media Library

ISA specific (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05476276 — Phase 2
Diabetic Neuropathy Research Study Groups: EN21-01 ISA, Placebo Comparator
Diabetic Neuropathy Clinical Trial 2023: ISA specific Highlights & Side Effects. Trial Name: NCT05476276 — Phase 2
ISA specific (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05476276 — Phase 2
Diabetic Neuropathy Patient Testimony for trial: Trial Name: NCT05476276 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still slots available for participants in this experiment?

"This medical trial can be found on clinicaltrials.gov and is actively seeking participants. It was first published on September 21st, 2022 with the most recent update occurring February 6th, 2023."

Answered by AI

How many locations have been approved for the management of this research study?

"Potential participants in this trial can be found at South Lake Pain Institute, Clermont; the University of Florida, Gainesville; Mount Sinai School of Medicine, New york and Washington. Additionally, there are 7 other clinical centres involved in this study."

Answered by AI

How many participants are contributing to this research project?

"This clinical trial necessitates 122 patients with appropriate inclusion criteria. There are multiple locations that can be utilised for enrollment, such as the South Lake Pain Institute in Clermont, Florida and the University of Florida in Gainesville, New york."

Answered by AI

Has EN21-01 ISA attained clearance from the FDA?

"Our team at Power believes EN21-01 ISA is relatively safe, scoring it a 2 on the safety scale. This assessment was made due to being a Phase 2 trial with some evidence of security, but no proof that this medication works effectively."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
Other
Massachusetts
New York
What site did they apply to?
University of Wisconsin
University of Rochester
MGH Department of Anesthesia, Critical Care, and Pain
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
1
2
0

What questions have other patients asked about this trial?

How long do visits take? How long do screenings take? How soon will I get a response??
PatientReceived no prior treatments
How long do screening visits take? Is mileage covered. How many visits required?
PatientReceived no prior treatments

Why did patients apply to this trial?

Improve my health. Nothing seems to work. See how I can be helped. I need help with my condition.
PatientReceived 2+ prior treatments
Dealing with this for 10 years.
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. University of Rochester: < 24 hours
  2. MGH Department of Anesthesia, Critical Care, and Pain: < 24 hours
  3. University of Wisconsin: < 24 hours
Average response time
  • < 2 Days
Typically responds via
Email
Phone Call
~41 spots leftby Jan 2025