Phase 3 Study of IV Neridronate for Treating Warm Subtype Complex Regional Pain Syndrome Type 1

What this Trial Is About

Researchers are evaluating the intravenous drug neridronate AMBTX-01 for treating adults with the warm subtype of Complex Regional Pain Syndrome Type 1 CRPS-1. This phase 3, multicenter, randomized, triple-blind, placebo-controlled trial aims to assess the efficacy, safety, and tolerability of neridronate 400 mg in participants who have a positive triple phase bone scan. The study is sponsored by Ambros Therapeutics, Inc. and focuses on improving pain and related symptoms in affected limbs. Participants will receive either 400 mg of neridronate or a placebo through intravenous infusion on Days 1, 4, 7, and 10. The trial includes a screening period lasting 2 to 6 weeks to confirm eligibility, followed by the four treatment infusions, and then a post-treatment follow-up period lasting through Week 12. The treatment and follow-up phases will monitor changes in pain and CRPS symptoms over time. During the study, participants will undergo various assessments including pain intensity measurements, CRPS severity scoring, physical functioning surveys, and global impressions of change. These evaluations occur at multiple timepoints including baseline, Days 4, 7, 10, and Weeks 3, 6, 9, and 12. Researchers will track medication use, limb temperature, edema, and sleep interference among other outcomes. The total participation duration is approximately up to 18 weeks, ensuring thorough monitoring of treatment effects and safety.

Evaluation of IV AMBTX-01 (Neridronate) for Treatment of CRPS Type 1 (CRPS-RISE)