Experimental nerve pain drug trial halted midway

NCT ID NCT05895552

What the study statuses mean

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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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 an experimental drug called RTA 901 to see if it could safely reduce nerve pain in people with diabetes. The trial planned to enroll 209 adults with diabetic peripheral neuropathic pain, comparing two doses of the drug against a placebo over 12 weeks. However, the study was terminated early, so results are limited.

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

209 people

The number who actually took part.

Started

Jul 2023

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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.

Run-in Inclusion Criteria: * Diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) at least 1 year prior to Screening * Clinical diagnosis of DPNP defined as symptomatic distal symmetric polyneuropathy (secondary to diabetes) in the lower extremities, which may include symptoms of pain that is burning, lancinating, tingling, or shooting (electric shock-like). Pain in the lower extremities may occur with paresthesia or dysesthesia (unpleasant sensations of burning). Neuropathic pain may be accompanied by an exaggerated response to painful stimuli (hyperalgesia) and pain evoked by light touch or contact, eg, with socks, shoes, and bedclothes (allodynia); * NPRS pain intensity score ≥ 4 on an 11-point scale at Screening * A score ≥ 2.5 on the Michigan Neuropathy Screening Instrument (MNSI) Part B Run-in Exclusion Criteria: * Has neuropathy from a cause other than T1DM or T2DM * Has a condition other than DPNP that could confound the assessment of pain (eg, fibromyalgia or regional pain caused by lumbar or cervical compression); * Diabetic foot ulceration or infection within 90 days prior to Screening * Prior participation in a study with RTA 901; NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • 3 Sync LLC

    Lake Worth, Florida, 33460, United States

  • 3 Sync LLC

    Sunrise, Florida, 33013, United States

  • 3 Sync LLC

    Kingwood, Texas, 77339, United States

  • Acclaim Clinical Research

    San Diego, California, 92120, United States

  • ActivMed Practices & Research, LLC

    Methuen, Massachusetts, 01844, United States

  • ActivMed Practices & Research, LLC

    Portsmouth, New Hampshire, 03801, United States

  • Agile Clinical Research Trials, LLC

    Atlanta, Georgia, 30328, United States

  • Amir A Hassan, MD, PA

    Houston, Texas, 77089, United States

  • Arizona Research Center

    Phoenix, Arizona, 85053, United States

  • Baycare Clinical Research

    Tampa, Florida, 33607, United States

  • Biopharma Informatic, LLC

    Houston, Texas, 77043, United States

  • Boston Clinical Trials, LLC

    Boston, Massachusetts, 02131, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02215, United States

  • Care United Research, LLC

    Forney, Texas, 75126, United States

  • Carolina Institute for Clinical Research, LLC

    Fayetteville, North Carolina, 28303, United States

  • Centricity Research Columbus Endocrinology

    Columbus, Georgia, 31904, United States

  • Centricity Research Phoenix Multispecialty

    Mesa, Arizona, 85206, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Clinical Research Consultants, LLC

    Kansas City, Missouri, 64111, United States

  • Clinical Research Institute

    Los Angeles, California, 90048, United States

  • Clinical Research of West Florida Inc

    Clearwater, Florida, 33765, United States

  • Clinical Research of West Florida, Inc.

    Tampa, Florida, 33606, United States

  • Clinical Site Partners, Orlando

    Winter Park, Florida, 32789, United States

  • Columbia University

    New York, New York, 10032, United States

  • Conquest Research, LLC

    Winter Park, Florida, 32789, United States

  • Denver Endocrinology Diabetes and Thyroid Center PC

    Englewood, Colorado, 80113, United States

  • Diabetes & Endocrinology Associates of Stark County, Inc.

    Canton, Ohio, 44718, United States

  • Diabetes & Glandular Disease Clinic, P.A.

    San Antonio, Texas, 78229, United States

  • Diabetes and Thyroid Center of Fort Worth

    Fort Worth, Texas, 76053, United States

  • East Coast Institute for Research, LLC

    Jacksonville, Florida, 32204, United States

  • East Coast Institute for Research, LLC

    Canton, Georgia, 30114, United States

  • East Coast Institute for Research, LLC

    Macon, Georgia, 31210, United States

  • Endocrine IPS, PLLC

    Houston, Texas, 77079, United States

  • Epic Clinical Research

    Lewisville, Texas, 75057, United States

  • Excel Clinical Research

    Las Vegas, Nevada, 89109, United States

  • Finlay Medical Research

    Miami, Florida, 33126, United States

  • Floridian Clinical Research

    Miami Lakes, Florida, 33016, United States

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731, United States

  • Genesis Clinical Research

    Tampa, Florida, 33603, United States

  • Hope Clinical Research, Inc.

    Canoga Park, California, 91303, United States

  • IMA Clinical Research, PC

    St. Petersburg, Florida, 33709, United States

  • Innovative Research of West Florida, Inc.

    Clearwater, Florida, 33756, United States

  • Integrated Clinical Trial Services, Inc.

    West Des Moines, Iowa, 50265, United States

  • Jubilee Clinical Research Inc

    Las Vegas, Nevada, 89106, United States

  • Las Vegas Endocrinology

    Henderson, Nevada, 89074, United States

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana, 47714, United States

  • Meta Medical Research Institute

    Dayton, Ohio, 45432, United States

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61606, United States

  • Multi Specialty Research Associates, LLC

    Lake City, Florida, 32055, United States

  • Nerve and Muscle Center of Texas

    Houston, Texas, 77030, United States

  • New Horizon Research Center

    Miami, Florida, 33165, United States

  • Notus Clinical Research

    Charleston, South Carolina, 29414, United States

  • Optimus Medical Group

    San Francisco, California, 94102, United States

  • PIH Health Whittier Hospital

    Whittier, California, 90606, United States

  • Paradigm Clinical Research

    Wheat Ridge, Colorado, 80033, United States

  • REX Clinical Trials, LLC

    Beaumont, Texas, 77701, United States

  • Rainier Clinical Research Center

    Renton, Washington, 98057, United States

  • Remington-Davis, Inc.

    Columbus, Ohio, 43215, United States

  • Revival Research Institute, LLC.

    Sterling Heights, Michigan, 48126, United States

  • Richmond Behavioral Associates

    Staten Island, New York, 10314, United States

  • Shadow Creek Medical Clinic

    Pearland, Texas, 77584, United States

  • StudyMetrix Research

    City of Saint Peters, Missouri, 63303, United States

  • Tandem Clinical Research

    Marrero, Louisiana, 70072, United States

  • Tandem Clinical Research

    Metairie, Louisiana, 70006, United States

  • Trinity Clinical Research LLC

    Tullahoma, Tennessee, 37388, United States

  • VICIS Clinical Research

    Tampa, Florida, 33615, United States

  • VIP Trials

    San Antonio, Texas, 78230, United States

  • Valley Research - Trials

    Fresno, California, 93720, United States

  • Velocity Clinical Research, Cincinnati

    Cincinnati, Ohio, 45242, United States

  • Velocity Clinical Research, Inc.

    Lincoln, Nebraska, 68510, United States

  • Velocity Clinical Research, Inc.

    Norfolk, Nebraska, 68510, United States

  • Velocity Clinical Research, Providence

    East Greenwich, Rhode Island, 68510, United States

  • Velocity Clinical Research, Salt Lake City

    West Jordan, Utah, 84088, United States

  • WR-ClinSearch, LLC

    Chattanooga, Tennessee, 37421, United States

  • Zenos Clinical Research

    Dallas, Texas, 75230, United States

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