Neridronate for Complex Regional Pain Syndrome

(CRPS-RISE Trial)

This trial tests a new treatment called neridronate, a bisphosphonate drug, for individuals with Complex Regional Pain Syndrome Type 1 (CRPS-1), a painful condition affecting a limb. The researchers aim to determine if neridronate can reduce pain and other symptoms compared to a placebo, which contains no active drug. The trial seeks participants who have experienced CRPS symptoms for six months or less and have noticeable swelling and redness in one limb. Individuals with CRPS-1 who meet these criteria might be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering a chance to contribute to potentially groundbreaking treatment advancements.

The trial does not specify if you must stop taking your current medications, but it mentions that participants cannot take certain treatments like bisphosphonates, denosumab, calcitonin, ketamine, or radiation therapy within specific timeframes before joining. It's best to discuss your current medications with the trial team to see if they are allowed.

Research has shown that neridronate is generally safe for people with complex regional pain syndrome (CRPS). One study found that intravenous neridronic acid, a type of neridronate, was safe for most people, as they did not experience serious side effects. Another study found that neridronate can help reduce pain in CRPS patients without causing major problems.

Unlike other treatments for Complex Regional Pain Syndrome, which often include pain relievers, nerve blocks, or physical therapy, neridronate is unique because it targets bone metabolism. Researchers are excited about neridronate because it is a bisphosphonate, which means it can help modify the disease process by affecting the bones directly. This is different from traditional treatments that mainly focus on managing symptoms rather than altering the underlying issue. The potential for neridronate to offer a more effective and lasting solution makes it an exciting prospect in the treatment of this challenging condition.

Research has shown that neridronate, which participants in this trial may receive, may help treat Complex Regional Pain Syndrome (CRPS). Studies have found that patients experienced quick and lasting relief from symptoms, with benefits lasting up to three years. Pain levels and disease severity decreased, and overall quality of life improved. Another study found that these improvements continued and even got better over a year for most patients. While some side effects were reported, the treatment's potential to reduce pain makes it a hopeful option for those with CRPS.¹²⁴⁶⁷