Skip to main content
Back to Trials
NCT07811362Recruiting

CRPS-RISE Outcomes Registry

Ambros Therapeutics, Inc.

Start Date

9/17/2026

Completion Date

4/16/2029

Summary

The goal of this observational study is to learn about how well neridronate keeps working in the months after treatment. For 12 or up to 24 months while the registry is open participants will answer online survey questions about their CRPS pain, medication use or procedures done and how CRPS affects what they are able to do.

Detailed Description

The primary objective of the registry is to evaluate the long-term effectiveness of IV neridronate across three outcome domains in participants who qualified in CRPS-RISE with early, warm CRPS-1 and a positive triple phase bone scan, following prior treatment with four infusions of neridronate 100 mg IV over approximately a 10-day period. The three outcome domains include, patient report of health status, CRPS-1 related clinical events, and disability status. No neridronate treatment will be given as part of the registry and limited safety information will be collected. Participants will have received neridronate either through CRPS-RISE and/or through the Open Label Extension.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Participants from CRPS-RISE 1. Completion of four infusions of IP (neridronate 100 mg over a \~ 10-day period \[or the renally modified dosing, as applicable\] or placebo) in CRPS-RISE . 2. Completed CRPS-RISE with a final trial visit at Week 6 (Visit 8) or later. Participants who meet both criteria will be provisionally enrolled pending post-trial unblinding and be included in the Provisionally Enrolled Study Cohort. After CRPS-RISE last patient last visit unblinding, only participants who meet the following neridronate exposure criterion #3 will continue in registry follow-up and be included in the Enrolled Study Cohort: 3. Completion of 4-infusions of neridronate 100 mg over approximately a 10-day period in CRPS-RISE. * Participants from the Open Label Extension (OLE) 1. Completion of 4 infusions of neridronate 100 mg over approximately a 10-day period (or the renally modified dosing, as applicable) in the OLE. 2. Completed OLE with a final trial visit at Week 6 (Visit 8) or later. Exclusion Criteria: There are no exclusion criteria.

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Complex Regional Pain Syndrome I (CRPS I)

Locations

CRPS-RISERegistry

Durham, North Carolina 27703

United States