NEW Diabetes and Pain Medication Study

Recruiting in Palo Alto (17 mi)

+20 other locations

Overseen ByJessica 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.

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.

Participant Groups

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.

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.