NCT07210515

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

A Randomized, Triple-blind, Placebo-controlled, Phase 3 Trial to Evaluate the Efficacy, Safety, and Tolerability of Intravenous AMBTX-01 (Neridronate) for Treatment of Complex Regional Pain Syndrome Type 1 (CRPS-RISE)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: Ambros Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase 3 Trial of AMBTX-01 (neridronate) for Complex Regional Pain Syndrome Type 1

Detailed description

This is a multicenter, randomized, triple-blind, controlled trial, to assess the efficacy, safety, and tolerability of neridronate 400 mg IV in adult participants with the warm subtype of Complex Regional Pain Syndrome Type 1 (CRPS-1) and a positive triple phase bone scan (TPBS). The total planned trial duration for each participant will be approximately up to 18 weeks and will include: * Screening period of up to 6 weeks * Treatment period on Days 1, 4, 7, and 10 * Post-treatment follow-up through week 12

Conditions

• Complex Regional Pain Syndrome Type I

Interventions

Type	Name	Description
DRUG	Neridronate	neridronate 100 mg, given as a 2-hour infusion on Days 1, 4, 7, and 10.
DRUG	Placebo	placebo comparator

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-12-01
• Completion: 2028-01-01
• First posted: 2025-10-07
• Last updated: 2026-03-31

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study