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NCT07811362From ClinicalTrials.govRecruiting

CRPS-RISE Outcomes Registry

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)

  • Complex Regional Pain Syndrome I (CRPS I)

At a glance

Phase
Phase not stated
Study type
Observational
Sponsor
Ambros Therapeutics, Inc.
Enrolment target
270
Started
17 September 2026
Main results due
16 April 2029
Study sites
1
Registry updated
29 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(1)

  • CRPS-RISERegistry

    Durham, North Carolina, United States

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07811362. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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CRPS-RISE Outcomes Registry | Trialion