At RSDSA, we want to keep you updated on research that may help improve treatment and awareness of Complex Regional Pain Syndrome (CRPS). We are excited to share news about a new trial called CRPS-RISE (Complex Regional Pain Syndrome-Relief and Improvement Study for Efficacy).
What is CRPS-RISE?
CRPS-RISE is a clinical research trial testing an investigational medicine called neridronate. The trial will help researchers learn whether this medicine can help reduce pain in adults with CRPS Type 1 (CRPS-1). The trial is run by Ambros Therapeutics, a clinical-stage biotechnology company based in Irvine, California.
What is neridronate?
Neridronate is a bisphosphonate, a type of drug that affects how bones are formed and broken down. It is “investigational”, meaning it has not been approved by the U.S. Food and Drug Administration (FDA). It can only be used in clinical trials like this one (except in Italy, where doctors already use it for CRPS-1). Because CRPS-1 is a rare disease and there are no approved medicines in the U.S., the FDA has given neridronate for CRPS three special designations: Orphan Drug, Breakthrough Therapy, and Fast Track. These designations mean that FDA recognizes the importance of developing treatments for CRPS.
Who Can Join?
CRPS-RISE will include about 270 adults who have CRPS-1. To join this clinical trial, you must:
- Be 18 years or older
- Have the “warm subtype” of CRPS-1, meaning the affected limb is red, warm, or/and swollen, and
- Have developed CRPS symptoms within the last 6 months
There are other considerations a trial doctor can discuss with you. Neridronate may help reduce the body’s reactions that cause pain and swelling in the warm subtype of CRPS-1. That is why the trial focuses on certain people with CRPS but not everyone. We are sharing this news so that potentially eligible patients are aware of this trial and have the chance to see if they qualify.
How the Trial Works
This is a “placebo-controlled” trial. This means:
- Participants are randomly placed into one of two groups (like a coin flip)
- One group gets neridronate
- The other group gets a placebo (a substance that looks the same but has no medicine in it)
Participants will receive four infusions through a small tube in the vein over 10 days. There will be a followup period, with the trial lasting up to 18 weeks (4 months).
After the trial, participants who are still experiencing symptoms of CRPS-1 may be able to receive neridronate through an expanded access program. This decision would be determined by your trial doctor and yourself.
Locations and Cost
The trial is expected to open at 60 different sites across the United States. There is no cost to participate, and help may be available to pay for travel to clinic visits.
Learn More
If you want to learn more about participating in this trial, Contact a Site. View a full and continually updated list of active research sites on https://clinicaltrials.gov/study/NCT07210515#contacts-and-locations.
We are hopeful for what this research means for the future of CRPS care!
