NEW Diabetes and Pain Medication Study

Recruiting at20 trial locations

Overseen by Jessica Robinson-Papp, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: James P. Rathmell, MD

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests several treatments for nerve pain in diabetic patients to identify effective therapies for reducing this type of pain.

Research Team

Jessica Robinson-Papp, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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.

Inclusion Criteria

I have Type 2 Diabetes.

I have diabetic neuropathy.

I experience pain in my legs, feet, toes, or ankles.

Exclusion Criteria

I have had a heart attack or stroke.

My diabetes treatment has been stable for at least 3 months with no expected changes.

Treatment Details

Interventions

• ISA specific (Other)

Trial Overview 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.

Participant Groups

Group I: EN21-01 ISA Experimental Treatment 1 Intervention

The EN21-01 Intervention Specific Analysis is detailed in the protocol (NCT#)

Group II: Placebo Comparator Placebo Group 1 Intervention

Each ISA will detail the use of the Placebo Comparator.

Who Is Running the Clinical Trial?

James P. Rathmell, MD

Lead Sponsor

Trials

2

Recruited

240+

New York University

Collaborator

Trials

249

Recruited

229,000+

Dr. Fritz François

New York University

Chief Medical Officer

MD from NYU Grossman School of Medicine

Dr. Robert I. Grossman

New York University

Chief Executive Officer since 2007

MD from NYU Grossman School of Medicine

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Jordan Gladman

National Institute of Neurological Disorders and Stroke (NINDS)

Chief Medical Officer

MD from Harvard Medical School

Walter J. Koroshetz

National Institute of Neurological Disorders and Stroke (NINDS)

Chief Executive Officer since 2007

MD from the University of Chicago

Icahn School of Medicine at Mount Sinai

Collaborator

Trials

933

Recruited

579,000+

Dr. Brendan Carr

Icahn School of Medicine at Mount Sinai

Chief Executive Officer since 2024

MD, MA, MS

Dr. Vicki LoPachin

Icahn School of Medicine at Mount Sinai

Chief Medical Officer

MD, FACP, MBA