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)
Phase 3 Trial of AMBTX-01 (neridronate) for Complex Regional Pain Syndrome Type 1
• Male or female participant ≥ 18 years of age at time of Screening.
• 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.
• Single affected limb at the Screening and Randomization Visits meeting the following warm subtype criteria:
‣ Edema in the affected limb
⁃ AND ≥ 2 of the following:
• Obvious redness in the affected region relative to the same region on the contralateral limb on inspection
∙ ≥ 1°C increase in temperature on the affected limb relative to the contralateral limb
∙ Moderate-to-severe edema
• CRPS symptoms ≤ 6 months since onset.
• Increased uptake in the involved limb compared to the contralateral limb on TPBS (phase 2 and/or phase 3) during Screening. A historic scan not older than 3 months prior to Randomization Visit is acceptable, if available and of sufficient quality for a central read.
• Pain now assessments of \> 4 on the 11 point numerical rating scale in the CRPS affected limb.
• Women of childbearing potential must:
‣ Be nonpregnant.
⁃ Be nonlactating.
⁃ Agree to use a highly effective method of contraception and for at least 6 months following last investigational product administration.
⁃ Exception: Women exclusively engaging in same sex sexual activities are not required to meet this criterion.