RecruitingPhase 3

Evaluation of IV AMBTX-01 (Neridronate) for Treatment of CRPS Type 1 (CRPS-RISE)

Ambros Therapeutics, Inc. · NCT07210515

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation: Not posted. Ask the study team before screening.
Who can join: Ages 18+ · All sexes
Healthy volunteers: Not accepted (a condition is required)
Study type: Interventional · Phase 3
Target enrollment: 270
US sites recruiting: 31
Study start: April 14, 2026
Record last updated: October 16, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

Phase 3 Trial of AMBTX-01 (neridronate) for Complex Regional Pain Syndrome Type 1

Being studied: Neridronate; Placebo

Conditions: Complex Regional Pain Syndrome Type I

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

Male or female participant ≥ 18 years of age at time of Screening.
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.
Single affected limb at the Screening and Randomization Visits meeting the following warm subtype criteria:

Edema in the affected limb
AND ≥ 2 of the following:

Obvious redness in the affected region relative to the same region on the contralateral limb on inspection
≥ 1°C increase in temperature on the affected limb relative to the contralateral limb
Moderate-to-severe edema
≤ 6 months since the onset of CRPS symptoms relative to the Randomization visit
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.
Women of childbearing potential must:

Be nonpregnant.
Be nonlactating.
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.

Adequate compliance with the eDiary during the screening period.

Exclusion Criteria

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.
≥ 40 points on the Pain Catastrophizing Scale.
Prior use of neridronate or participation in a clinical study where the participant may have received neridronate.
The use of any of the following treatments within the timeframe specified from Randomization Visit:

Within the last 12 months:

IV bisphosphonates
IV immunoglobulin
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
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.
Severely impaired renal function.
Hypocalcemia.
Vitamin D deficiency.
Significant dental findings such as an unhealed tooth extraction site.
Eye inflammation.
Significantly elevated liver-related lab tests or evidence of significant liver disease.
Clinically unstable cardiac disease.
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.

Recruiting US locations

Ambros Clinical Trial Site
Phoenix, AZ 85032
Site contact: +1 602-288-4673 · shana.harshell@hriaz.com
Ambros Clinical Trial Site
Tucson, AZ 85710
Site contact: +1 520-495-4680 · melissa@qlmc.com
Ambros Clinical Trial Site
Little Rock, AR 72205
Site contact: +1 501-398-8622 · HHattabaugh@uams.edu
Ambros Clinical Trial Site
La Jolla, CA 92093
Site contact: +1 619-518-8333 · vpolk@health.ucsd.edu
Ambros Clinical Trial Site
Napa, CA 94558
Site contact: +1 707-252-9606 · nichole@neurovations.com
Ambros Clinical Trial Site
Pasadena, CA 91105
Site contact: grazy@havanaresearchinstitute.com
Ambros Clinical Trial Site
Santa Monica, CA 90404
Site contact: +1 310-264-7246 · kguzman@crpscenter.com
Ambros Clinical Trial Site
Tustin, CA 92780
Site contact: +1 562-652-0005 · hikyhe@solacecr.com
Ambros Clinical Trial Site
Washington D.C., DC 20006
Site contact: +1 202-808-8295 · drdesai@isppcenter.com
Ambros Clinical Trial Site
Brandon, FL 33511
Site contact: +1 941-780-9224 · sstickels@synergyhealthcorp.com; ckelly@synergyhealthcorp.com
Ambros Clinical Trial Site
Daytona Beach, FL 32117
Site contact: +1 386-278-8000 · awillhoite@arrowtrials.com
Ambros Clinical Trial Site
Pembroke Pines, FL 33025
Site contact: +1 954-852-5484 · a.garciaduconge@optimumcareresearch.com
Ambros Clinical Trial Site
Lawrenceville, GA 30046
Site contact: +1 470-657-6031 · mosyaw.stephens@skycrng.com
Ambros Clinical Trial Site
Newnan, GA 30265
Site contact: +1 770-755-6914 · dhelton@vistaclinresearch.com
Ambros Clinical Trial Site
Orland Park, IL 60462
Site contact: +1 646-744-5943 · nag@m1-health.com
Ambros Clinical Trial Site
Overland Park, KS 66210
Site contact: +1 913-825-2314 · amy.r@neuroscienceresearchctr.com
Ambros Clinical Trial Site
Reno, NV 89511
Site contact: 775-284-8650 · madeline@nvadvancedpain.com
Ambros Clinical Trial Site
Shrewsbury, NJ 07702
Site contact: KGee@treatingpain.com
Ambros Clinical Trial Site
Charlotte, NC 28211
Site contact: +1 704-405-3150 · shill@qccresearch.com
Ambros Clinical Trial Site
Wilmington, NC 28412
Site contact: +1 910-408-5746 · tmahaffey@wakeresearch.com
Ambros Clinical Trial Site
Winston-Salem, NC 27103
Site contact: +1 336-765-6181 · Hreyna@ccrpain.com
Ambros Clinical Trial Site
Cleveland, OH 44130
Site contact: +1 440-234-5700 · jheil@northstarresearch.org
Ambros Clinical Trial Site
Dayton, OH 45432
Site contact: +1 937-252-2000 ext 251 · bkulkarni@metamedresearch.com
Ambros Clinical Trial Site
Fort Worth, TX 76244
Site contact: +1 214 407-8640 · mavalos@stryderesearch.com
Ambros Clinical Trial Site
Houston, TX 77079
Site contact: +1 832-969-6157 · sekeia.willis@sclamanagement.com
Ambros Clinical Trial Site
Lubbock, TX 79410
Site contact: +1 877-972-7576 · keely.esch@sclamanagement.com
Ambros Clinical Trial Site
Mesquite, TX 75150
Ambros Clinical Trial Site
Mesquite, TX 75150
Site contact: +1 972 599-1530 · DeZaria.kidd@citplano.com
Ambros Clinical Trial Site
Charlottesville, VA 22903
Site contact: +1 434-688-6678 · MI9K@uvahealth.org
Ambros Clinical Trial Site
Richmond, VA 23238
Site contact: +1 804-330-2611 · crc2@vaispine.com
Ambros Clinical Trial Site
Seattle, WA 98195
Site contact: +1 206-807-1430 · crpsrise@uw.edu

Study contacts (from the official record)

Medical Affairs · +1 949-508-0173 · Medinfo@ambrostx.com
Ambros Therapeutics, Inc