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)
Ambros Therapeutics, Inc.
Summary
Phase 3 Trial of AMBTX-01 (neridronate) for Complex Regional Pain Syndrome Type 1
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 2 up to 6 weeks * Treatment period on Days 1, 4, 7, and 10 * Post-treatment follow-up through week 12
Eligibility
- Age range
- 18+ years
- Sex