| NCT ID | NCT07811362 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ambros Therapeutics, Inc. |
| Condition | Complex Regional Pain Syndrome I (CRPS I) |
| Study Type | OBSERVATIONAL |
| Enrollment | 270 participants |
| Start Date | 2026-09-17 |
| Primary Completion | 2029-04-16 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 270 participants in total. It began in 2026-09-17 with a primary completion date of 2029-04-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Joel Castellanos, MD
PRINCIPAL INVESTIGATOR
UCSD
Frequently Asked Questions
Who can join the NCT07811362 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Complex Regional Pain Syndrome I (CRPS I). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07811362 currently recruiting?
Yes, NCT07811362 is actively recruiting participants. Contact the research team at CRPS-RiseRegistry@iqvia.com for enrollment information.
Where is the NCT07811362 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT07811362 clinical trial?
NCT07811362 is sponsored by Ambros Therapeutics, Inc.. The principal investigator is Joel Castellanos, MD at UCSD. The trial plans to enroll 270 participants.