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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Ambros Therapeutics, Inc.
Study ID
NCT07210515
Phase
PHASE3
Status
Recruiting
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Conditions

  • Complex Regional Pain Syndrome Type I

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Neridronate — DRUG
    neridronate 100 mg, given as a 2-hour infusion on Days 1, 4, 7, and 10.
  • Placebo — DRUG
    placebo comparator

Study Details

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

Key Dates

First listed
Oct 7, 2025
Start date
Apr 14, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
270 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: neridronate
    400 mg AMBTX-01 infusion
  • Placebo Comparator: Placebo
    Placebo comparator

Primary Outcome Measure

Change in pain intensity from baseline to Week 12. [ Time Frame: Week 12 ]

Central Contacts

Locations (19)

FacilityCityStateZIPSite coordinators
Ambros Clinical Trial SitePhoenixArizona85032-
Ambros Clinical Trial SiteTucsonArizona85710-
Ambros Clinical Trial SiteNapaCalifornia94558-
Ambros Clinical Trial SitePasadenaCalifornia91105-
Ambros Clinical Trial SiteTustinCalifornia92780-
Ambros Clinical Trial SiteWashington D.C.District of Columbia20006-
Ambros Clinical Trial SiteBrandonFlorida33511-
Ambros Clinical Trial SiteDaytona BeachFlorida32117-
Ambros Clinical Trial SitePembroke PinesFlorida33025-
Ambros Clinical Trial SiteLawrencevilleGeorgia30046-
Ambros Clinical Trial SiteNewnanGeorgia30265-
Ambros Clinical Trial SiteChicagoIllinois60640-
Ambros Clinical Trial SiteOrland ParkIllinois60462-
Ambros Clinical Trial SiteRenoNevada89511-
Ambros Clinical Trial SiteShrewsburyNew Jersey07702-
Ambros Clinical Trial SiteCharlotteNorth Carolina28211-
Ambros Clinical Trial SiteWilmingtonNorth Carolina28412-
Ambros Clinical Trial SiteWinston-SalemNorth Carolina27103-
Ambros Clinical Trial SiteHoustonTexas77079-

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