Actively Recruiting
Evaluation of IV AMBTX-01 (Neridronate) for Treatment of CRPS Type 1 (CRPS-RISE)
Led by Ambros Therapeutics, Inc. · Updated on 2026-05-14
270
Participants Needed
7
Research Sites
89 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase 3 Trial of AMBTX-01 (neridronate) for Complex Regional Pain Syndrome Type 1
CONDITIONS
Official Title
Evaluation of IV AMBTX-01 (Neridronate) for Treatment of CRPS Type 1 (CRPS-RISE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older at screening
- Diagnosed with CRPS-1 using clinical Budapest Criteria, with no known peripheral nerve injury
- CRPS symptoms affecting only one limb showing asymmetry compared to the opposite limb
- Warm subtype CRPS with edema and at least two of the following: redness, temperature increase of 16C or more, or moderate-to-severe edema
- Symptoms present for 6 months or less before randomization
- Positive triple phase bone scan showing increased uptake in the affected limb within 3 months prior to randomization
- Women of childbearing potential must be nonpregnant, nonlactating, and agree to use highly effective contraception during and for 6 months after treatment, except women exclusively having same-sex sexual activity
- Adequate compliance with electronic diary during screening
You will not qualify if you...
- Diagnosis of CRPS Type 2, CRPS not otherwise specified, or CRPS-1 without warm subtype criteria
- Pain Catastrophizing Scale score of 40 points or higher
- Prior use of neridronate or participation in a study with neridronate
- Use of IV bisphosphonates or IV immunoglobulin within 12 months before randomization
- Use of oral bisphosphonates, denosumab, RANKL inhibitors, calcitonin, ketamine, or head/neck radiation therapy within 6 months before randomization
- Use or planned use of prohibited concomitant medications or therapies or inability to follow protocol restrictions
- Severely impaired kidney function
- Low blood calcium levels (hypocalcemia)
- Vitamin D deficiency
- Significant dental issues such as unhealed tooth extraction
- Eye inflammation
- Significantly elevated liver tests or liver disease
- Clinically unstable heart disease
- Any condition within 3 months prior to screening or randomization that may interfere with CRPS assessment, pain evaluation, safety, or study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Ambros Clinical Trial Site
Phoenix, Arizona, United States, 85032
Actively Recruiting
2
Ambros Clinical Trial Site
Tucson, Arizona, United States, 85710
Actively Recruiting
3
Ambros Clinical Trial Site
Tustin, California, United States, 92780
Actively Recruiting
4
Ambros Clinical Trial Site
Brandon, Florida, United States, 33511
Actively Recruiting
5
Ambros Clinical Trial Site
Pembroke Pines, Florida, United States, 33025
Actively Recruiting
6
Ambros Clinical Trial Site
Newnan, Georgia, United States, 30265
Actively Recruiting
7
Ambros Clinical Trial Site
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
Research Team
S
SVP, Clinical Operations
CONTACT
A
Ambros Therapeutics, Inc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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