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)

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.

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.

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.