Ambros Therapeutics, Inc.
Phase 3 Trial of AMBTX-01 (neridronate) for Complex Regional Pain Syndrome Type 1
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
Inclusion Criteria: 1. Male or female participant ≥ 18 years of age at time of Screening. 2. A diagnosis of CRPS-1 according to the clinical Budapest Criteria as recommended by the International Association for the Study of Pain (IASP), as well as no known peripheral nerve injury. Signs and symptoms of CRPS must apply to a single identified affected limb (i.e., arm, hand, wrist, leg, ankle or foot) and must demonstrate asymmetry with respect to the contralateral limb. 3. Single affected limb at the Screening and Randomization Visits meeting the following warm subtype criteria: 1. Edema in…
neridronate 100 mg, given as a 2-hour infusion on Days 1, 4, 7, and 10.
placebo comparator