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New pill aims to quiet diabetic nerve pain

NCT ID NCT05480228

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

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.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

127 people

The number who actually took part.

Started

Sep 2022

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

7.1 ISA-Specific Inclusion Criteria (To be used in conjunction with Platform Protocol criteria; note, some ISA criteria may be more stringent than Platform criteria; always follow the more stringent criteria when determining eligibility.) 1. Provides written consent for the EN21-01 ISA. Legally Authorized Representatives (LARs) are not allowed, but impartial witnesses may be utilized as needed for visually impaired participants. 2. Patient-reported daily 11-point NRS (for average pain over the last 24 hours) meets the criteria specified in "Appendix B: Blinded Information" during both the 7-day screening and 7-day baseline periods. The algorithm will be assessed centrally. Waivers to the inclusion criteria will not be allowed. 7.2 ISA-Specific Exclusion Criteria (To be used in conjunction with Platform Protocol criteria; note, some ISA criteria may be more stringent than Platform criteria; always follow the more stringent criteria when determining eligibility.) Participants fulfilling any of the following criteria are not eligible for the study. 1. Diagnosis of alcohol or substance abuse or dependence (other than nicotine or caffeine) within the 2 years before the Screening visit. \*\*This criterion is more stringent than a related Platform Protocol criterion.\*\* 2. Moderate or severe renal impairment, known (documented) or defined as an estimated/calculated creatinine clearance/estimated glomerular filtration rate (eGFR) \< 45 mL/min/1.73 m2, according to the Chronic Kidney Disease Epidemiology Collaboration formula during the screening process. \*\*This criterion is more stringent than a related Platform Protocol criterion.\*\* 3. Any of the following conditions related to corrected QT intervals using Fridericia's formula (QTcF): 1. A QTcF \> 500 ms prior to starting IP, up to and including the V3 pre-dose ECG. 2. A history of the following additional risk factors for torsade de pointes: heart failure, hypokalemia, history or family history of long QT syndrome. 4. History of myocardial infarction, other clinically active significant heart disease, or stroke. \*\*This criterion is more stringent than a related Platform Protocol criterion.\*\* 5. Participants known to have participated in four or more studies for investigational pain drugs. 6. Participants known to be non-responders to more than three previous neuropathic pain medications at adequate doses over at least 4 weeks. Adequate doses (given as total daily doses) are defined as follows: 1,800 mg gabapentin; 300 mg pregabalin; opioid analgesics 60 mg oxycodone equivalent or 200 mg tramadol; 75 mg amitriptyline or equivalent tricyclic antidepressant; 60 mg duloxetine; 150 mg venlafaxine. 7. Known hypersensitivity or contraindication to any excipients of the study drug formulation. 8. Taking prohibited medications as described in Appendix A, "Prohibited Medications." 9. Major depressive episode within the 6 months before screening and/or a history of diagnosed recurrent major depressive disorder within two years. Any of the following conditions related to suicidality: 1. Any suicidal ideation with intent, with or without a plan, at screening, i.e., answering "yes" to questions 4 or 5 on the Suicidal Ideation section of the Baseline/Screening version of the Columbia-Suicide Severity Rating Scale (C-SSRS); 2. Answering "yes" on any item of the Suicidal Behavior Section (except for the "non-suicidal self-injurious behavior") of the C-SSRS if this behavior occurred in the past 2 years; 3. A lifetime history of suicide attempt (V1). 10. Previous known or possible exposure to NRD135S.E1. Waivers to the exclusion criteria will not be allowed.

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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

Contacts and locations

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.