What happens after neridronate treatment for CRPS Type 1
Official title: A Prospective Longitudinal Outcomes Registry of Complex Regional Pain Syndrome Type 1 (CRPS-1) in Participants Treated With Neridronate in the CRPS-RISE Trial and/or Open-Label Extension (OLE)
Run by Ambros Therapeutics, Inc. · NCT07811362 · Data updated 2026-11-12
This registry follows people with CRPS Type 1 to see how long the benefits of IV neridronate last over 12 to 24 months.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 270 (estimated) |
| Sponsor | Ambros Therapeutics, Inc. Industry-sponsored |
| Locations | 1 site (Durham, North Carolina) |
| Status | Recruiting |
| Started | September 17, 2026 |
| Main results expected | April 16, 2029 |
| Study ends | April 16, 2029 |
| Registry record updated | September 29, 2026 |
| Trial ID | NCT07811362 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Participants who completed CRPS-RISE and either received four IV infusions of neridronate or completed the open-label extension are eligible for provisional enrollment.
✕Probably not a fit
Patients who did not receive neridronate in the earlier studies or who do not complete post-treatment follow-up may not experience measurable benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational registry that tracks long-term outcomes after neridronate treatment for CRPS Type 1. Participants who previously received neridronate in CRPS-RISE or its open-label extension will complete online surveys about pain, medications, procedures, and daily functioning for up to two years. The study does not administer neridronate as part of the registry and collects limited safety information. The registries’ primary focus is on health status, CRPS-related clinical events, and disability over time.
Why it matters
Potential benefit: If successful, the registry could clarify how durable neridronate benefits are for CRPS Type 1 patients.
How similar studies have gone: Previous studies in this area suggest there can be lasting effects from neridronate, but long-term registry data are limited and this approach is building on prior work.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
CRPS-RISERegistry
Durham, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Joel Castellanos, MD — UCSD
- Study coordinator: CRPS-RiseRegistry
- Email: CRPS-RiseRegistry@iqvia.com
- Phone: 877-834-5183
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
CRPS of the hand: Contrast plus compression vs whirlpool therapy
This randomized study tests whether a combined contrast therapy with intermittent compression helps people with CRPS-I in the hand and wrist more than whirlpool therapy.
-
Neridronate extension study for CRPS-1
This study tests IV neridronate in people with CRPS-1 who completed a previous trial, to see if it continues to help with pain and symptoms.
-
IV neridronate for warm-type Complex Regional Pain Syndrome (CRPS-1) with a positive bone scan
This trial will try IV neridronate to reduce pain and swelling in adults with recent-onset warm-subtype CRPS-1 who have a positive triple-phase bone scan.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.