CRPS-RISE Clinical Trial

Now Enrolling Participants

Do you or someone you know have ongoing pain, swelling, or changes in skin color or temperature after an injury or surgery?

Doctors and researchers are studying a possible new treatment for Complex Regional Pain Syndrome Type 1 (CRPS-1).

The CRPS-RISE trial aims to find out whether an investigational drug may reduce pain and other CRPS symptoms in adults with the “warm” subtype of Complex Regional Pain Syndrome Type 1 (CRPS-1).

Complex Regional Pain Syndrome Type 1 (CRPS-1). People with CRPS feel pain that is stronger and/or longer than what would be expected from the original injury. CRPS can last for months or even years. The “warm” subtype means the affected limb may be swollen, red, and/or warm.

CRPS-RISE is testing a medicine called neridronate.

Neridronate is a bisphosphonate, a type of drug that affects how bones are formed and broken down. In Italy, neridronate is approved for doctors to prescribe to people with various conditions, including CRPS. Neridronate is not approved for the treatment of CRPS-1 in the US. It is being researched in trials such as this one with permission from the U.S. Food and Drug Administration (FDA).

CRPS-RISE will compare neridronate with a placebo. A placebo looks like the investigational drug but does not contain any active ingredients. You will have an equal (50/50) chance of receiving either the investigational drug or placebo. This will be chosen at random by a computer. You will not know which you are receiving.

You will receive the trial treatment by IV infusion. This means the investigational drug or placebo will flow through a mean tube inserted into one of your veins.

This trial may be suitable for you if you have been diagnosed with CRPS-1 and:

• Are at least 18 years of age
• Have started having symptoms within the last 6 months
• Have CRPS in only one limb and that limb is swollen, red, and/or warm

If you are able to join, the trial lasts up to 18 weeks (about 4 months). This includes:

• Screening visit: Up to 6 weeks
• Treatment period: 2 weeks with 4 IV Infusions.
• Follow-up period: 10 weeks with 3 in-clinic visits and 2 phone calls

Study-related treatment and procedures will be provided at no cost to participants.

You may be compensated for the visits and completion of a daily electronic diary. Please ask the study team for details.

If you would like to learn whether you may qualify for the CRPS-RISE study, please complete the contact form here and a study coordinator will reach out to you.