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Could a bone drug ease CRPS pain? large trial underway

NCT ID NCT07210515

Symptom relief Sponsor: Ambros Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 11, 2026 · Updated 14 times

Summary

This phase 3 trial tests whether the drug neridronate, given as four IV infusions over 10 days, can reduce pain and other symptoms of complex regional pain syndrome type 1 (CRPS-1). About 270 adults with CRPS in one limb will receive either the drug or a placebo. The main goal is to see if pain levels drop more with neridronate after 12 weeks.

What this could mean

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

Active substance
Neridronate (a bisphosphonate drug given intravenously)
What this could lead to
If it works, this could provide a new treatment option to reduce pain and severity of CRPS type 1.
What could go wrong
This is a phase 3 trial, but previous results may not guarantee success. The drug may not outperform placebo, and side effects from IV infusions are possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 270 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Jan 2028

An estimate. End dates often move.

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.

Inclusion Criteria: 1. Male or female participant ≥ 18 years of age at time of Screening. 2. A diagnosis of CRPS-1 according to the clinical Budapest Criteria as recommended by the International Association for the Study of Pain (IASP), as well as no known peripheral nerve injury. Signs and symptoms of CRPS must apply to a single identified affected limb (i.e., arm, hand, wrist, leg, ankle or foot) and must demonstrate asymmetry with respect to the contralateral limb. 3. Single affected limb at the Screening and Randomization Visits meeting the following warm subtype criteria: 1. Edema in the affected limb 2. AND ≥ 2 of the following: 1. Obvious redness in the affected region relative to the same region on the contralateral limb on inspection 2. ≥ 1°C increase in temperature on the affected limb relative to the contralateral limb 3. Moderate-to-severe edema 4. ≤ 6 months since the onset of CRPS symptoms relative to the Randomization visit 5. Increased uptake in the involved limb compared to the contralateral limb on TPBS (phase 2 and/or phase 3) during Screening. A historic scan not older than 3 months prior to Randomization Visit is acceptable, if available and of sufficient quality for a central read. 6. Women of childbearing potential must: 1. Be nonpregnant. 2. Be nonlactating. 3. Agree to use a highly effective method of contraception and for at least 6 months following last investigational product administration. Exception: Women exclusively engaging in same sex sexual activities are not required to meet this criterion. 7. Adequate compliance with the eDiary during the screening period. Exclusion Criteria 1. A current or prior diagnosis of CRPS Type 2 or CRPS not otherwise specified (CRPS NOS), or whose CRPS has no known inciting event, or CRPS-1 without criteria of the warm subtype at the time of Screening. 2. ≥ 40 points on the Pain Catastrophizing Scale. 3. Prior use of neridronate or participation in a clinical study where the participant may have received neridronate. 4. The use of any of the following treatments within the timeframe specified from Randomization Visit: 1. Within the last 12 months: * IV bisphosphonates * IV immunoglobulin 2. Within the last 6 months: * Any oral bisphosphonate, denosumab (Prolia®) or receptor activator of nuclear factor kappa B ligand (RANKL) inhibitors (e.g., denosumab biosimilar compounds) * Calcitonin * Ketamine * Radiation therapy to the head or neck 5. Participants currently taking or planning to be treated with prohibited concomitant medications/therapies, or not likely able to follow the protocol restrictions for use of concomitant treatment. 6. Severely impaired renal function. 7. Hypocalcemia. 8. Vitamin D deficiency. 9. Significant dental findings such as an unhealed tooth extraction site. 10. Eye inflammation. 11. Significantly elevated liver-related lab tests or evidence of significant liver disease. 12. Clinically unstable cardiac disease. 13. Any known conditions, from 3 months prior to Screening Visit or to the Randomization Visit, that may interfere with the assessment of CRPS-1, CRPS-related pain, safety, or other trial assessments.

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Conditions

The condition(s) this trial relates to.

complex regional pain syndrome complex regional pain syndrome type 1 Edema Pain

As listed by the trial registrant

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

Complex regional pain syndrome type I

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    27 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ambros Clinical Trial Site

    RECRUITING

    Phoenix, Arizona, 85032, United States

  • Ambros Clinical Trial Site

    RECRUITING

    Tucson, Arizona, 85710, United States

  • Ambros Clinical Trial Site

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • Ambros Clinical Trial Site

    RECRUITING

    La Jolla, California, 92093, United States

  • Ambros Clinical Trial Site

    RECRUITING

    Napa, California, 94558, United States

  • Ambros Clinical Trial Site

    RECRUITING

    Pasadena, California, 91105, United States

  • Ambros Clinical Trial Site

    RECRUITING

    Tustin, California, 92780, United States

  • Ambros Clinical Trial Site

    RECRUITING

    Washington D.C., District of Columbia, 20006, United States

  • Ambros Clinical Trial Site

    RECRUITING

    Brandon, Florida, 33511, United States

  • Ambros Clinical Trial Site

    RECRUITING

    Daytona Beach, Florida, 32117, United States

  • Ambros Clinical Trial Site

    RECRUITING

    Pembroke Pines, Florida, 33025, United States

  • Ambros Clinical Trial Site

    RECRUITING

    Lawrenceville, Georgia, 30046, United States

  • Ambros Clinical Trial Site

    RECRUITING

    Newnan, Georgia, 30265, United States

  • Ambros Clinical Trial Site

    RECRUITING

    Orland Park, Illinois, 60462, United States

  • Ambros Clinical Trial Site

    RECRUITING

    Overland Park, Kansas, 66210, United States

  • Ambros Clinical Trial Site

    RECRUITING

    Reno, Nevada, 89511, United States

  • Ambros Clinical Trial Site

    RECRUITING

    Shrewsbury, New Jersey, 07702, United States

  • Ambros Clinical Trial Site

    RECRUITING

    Charlotte, North Carolina, 28211, United States

  • Ambros Clinical Trial Site

    RECRUITING

    Wilmington, North Carolina, 28412, United States

  • Ambros Clinical Trial Site

    RECRUITING

    Winston-Salem, North Carolina, 27103, United States

  • Ambros Clinical Trial Site

    RECRUITING

    Dayton, Ohio, 45432, United States

  • Ambros Clinical Trial Site

    RECRUITING

    Fort Worth, Texas, 76244, United States

  • Ambros Clinical Trial Site

    RECRUITING

    Houston, Texas, 77079, United States

  • Ambros Clinical Trial Site

    RECRUITING

    Lubbock, Texas, 79410, United States

  • Ambros Clinical Trial Site

    RECRUITING

    Mesquite, Texas, 75150, United States

  • Ambros Clinical Trial Site

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • Ambros Clinical Trial Site

    RECRUITING

    Seattle, Washington, 98195, United States

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