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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
227 Previous Clinical Trials
312,847 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,347 Previous Clinical Trials
650,642 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
~32 spots leftby Jan 2025
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