Evaluation of IV AMBTX-01 (Neridronate) for Treatment of CRPS Type 1 (CRPS-RISE)
Start Date
4/14/2026
Completion Date
1/1/2028
Summary
Phase 3 Trial of AMBTX-01 (neridronate) for Complex Regional Pain Syndrome Type 1
Detailed Description
This is a multicenter, randomized, triple-blind, controlled trial, to assess the efficacy, safety, and tolerability of neridronate 400 mg IV in adult participants with the warm subtype of Complex Regional Pain Syndrome Type 1 (CRPS-1) and a positive triple phase bone scan (TPBS). The total planned trial duration for each participant will be approximately up to 18 weeks and will include: * Screening period of 2 up to 6 weeks * Treatment period on Days 1, 4, 7, and 10 * Post-treatment follow-up through week 12
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Neridronate
Placebo
Conditions
Locations
Ambros Clinical Trial Site
Phoenix, Arizona 85032
United States
Ambros Clinical Trial Site
Tucson, Arizona 85710
United States
Ambros Clinical Trial Site
Napa, California 94558
United States
Ambros Clinical Trial Site
Pasadena, California 91105
United States
Ambros Clinical Trial Site
Tustin, California 92780
United States
Ambros Clinical Trial Site
Washington D.C., District of Columbia 20006
United States
Ambros Clinical Trial Site
Brandon, Florida 33511
United States
Ambros Clinical Trial Site
Pembroke Pines, Florida 33025
United States
Ambros Clinical Trial Site
Newnan, Georgia 30265
United States
Ambros Clinical Trial Site
Chicago, Illinois 60640
United States
Ambros Clinical Trial Site
Orland Park, Illinois 60462
United States
Ambros Clinical Trial Site
Charlotte, North Carolina 28211
United States
Ambros Clinical Trial Site
Wilmington, North Carolina 28412
United States
Ambros Clinical Trial Site
Winston-Salem, North Carolina 27103
United States
Ambros Clinical Trial Site
Houston, Texas 77079
United States