New pill aims to quiet diabetic nerve pain

NCT ID NCT05480228

Completed Symptom relief Sponsor: James P. Rathmell, MD Source: ClinicalTrials.gov ↗

First seen Jan 05, 2026 · Last updated Jun 23, 2026 · Updated 24 times

Summary

This study tested whether a daily capsule called NRD135S.E1 can safely reduce nerve pain caused by diabetes. 127 adults with painful diabetic neuropathy took either the drug or a placebo for 13 weeks. Researchers measured pain changes using a 0-10 scale and tracked any side effects.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

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Locations

American Indian Clinical Trials Research Network

Rapid City, South Dakota, 57701, United States
Clinical Inquest Center

Beavercreek, Ohio, 45431, United States
Clinicore International

Houston, Texas, 77077, United States
Columbia University Medical Center/Neurological Institute

New York, New York, 10032, United States
Eastern Virginia Medical School

Norfolk, Virginia, 23510, United States
Healthcare Research Network (Flossmoor)

Flossmoor, Illinois, 60422, United States
Healthcare Research Network (Hazelwood)

Hazelwood, Missouri, 63042, United States
Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States
Low Country Pain Center

Orangeburg, South Carolina, 29118, United States
MGH Department of Anesthesia, Critical Care, and Pain

Boston, Massachusetts, 02114, United States
Mount Sinai School of Medicine

New York, New York, 10029, United States
NYU Langone Manhattan

New York, New York, 10017, United States
Nerve and Muscle Center of Texas

Houston, Texas, 77030, United States
Northwestern Department of Neurology

Chicago, Illinois, 60611, United States
SIMEDHealth LLC

Gainesville, Florida, 32607, United States
South Lake Pain Institute

Clermont, Florida, 34711, United States
University of California, San Diego

San Diego, California, 92037, United States
University of Florida

Gainesville, Florida, 32611, United States
University of Kansas Medical Center

Kansas City, Kansas, 66160, United States
University of Maryland - Baltimore

Baltimore, Maryland, 21201, United States
University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States
University of Rochester

Rochester, New York, 14627, United States
University of Utah School of Medicine

Salt Lake City, Utah, 84132, United States
University of Washington

Seattle, Washington, 98195, United States
University of Wisconsin

Madison, Wisconsin, 53706, United States
VCU Department of Neurology

Richmond, Virginia, 23298, United States

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

NRD135S.E1 (a small chemical entity taken as a daily capsule)

What this could lead to

If it works, this could point toward a new daily pill to reduce nerve pain in people with diabetes.

What could go wrong

This is a small, early phase 2 trial. The drug may not work better than placebo, and side effects are possible. Results may not apply to everyone with diabetic nerve pain.

Conditions

The condition(s) this trial relates to.

diabetic neuropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

PAINFUL DIABETIC NEUROPATHY PAINFUL DIABETIC NEUROPATHY